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Access Pharmaceuticals Reports Significant Oral Bioavailability of Cobalamin(TM) Oral Insulin in Additional Studies

Thu, 11 Mar 2010

Dallas, TX, March 11, 2010 - ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) announced that it has received reports of significant bioavailability of orally delivered insulin in two independently-conducted animal studies. The studies, which confirm earlier findings, were performed as part of on-going work with commercial collaborators that are evaluating Access’ Cobalamin™ Oral Drug Delivery Technology.

Seattle Genetics Expands Antibody-Drug Conjugate Patent Portfolio

Thu, 11 Mar 2010

BOTHELL, Wash., Mar 11, 2010 (BUSINESS WIRE) -- Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that the U.S. Patent and Trademark Office has issued a patent related to its antibody-drug conjugate (ADC) technology. U.S. Patent No. 7,659,241 covers cleavable linkers and potent auristatin drug payloads used in certain of Seattle Genetics' ADC programs, most notably brentuximab vedotin (SGN-35), as well as many ADC programs in development by its collaborators. Brentuximab vedotin, an ADC that utilizes the vcMMAE drug-linker unit, is in a pivotal trial for relapsed and refractory Hodgkin lymphoma and a phase II trial for relapsed and refractory systemic anaplastic large cell lymphoma. The company anticipates submitting a New Drug Application for brentuximab vedotin in the first half of 2011.

Advanced Life Sciences Receives FDA Guidance on Approval Pathway for Restanza in Community Acquired Bacterial Pneumonia and Biodefense Indications

Thu, 11 Mar 2010

CHICAGO, March 11, 2010 /PRNewswire via COMTEX/ -- Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, announced today that the U.S. Food and Drug Administration (FDA) has provided guidance on the clinical program required to assess the approvability of Restanza(TM) (cethromycin), a novel oral once-a-day antibiotic, in the treatment of outpatient community acquired bacterial pneumonia (CABP) as well as biodefense indications including anthrax, plague and tularemia.

Genta Initiates Phase 2 Study of Tesetaxel, the Leading Clinical-Stage Oral Taxane, in Patients with Advanced Melanoma

Tue, 9 Mar 2010

BERKELEY HEIGHTS, NJ – February 8, 2010 - Genta Incorporated (OTCBB: GETA) announced that the Company has initiated treatment of the first subject in a new Phase 2 trial of tesetaxel in advanced melanoma. Tesetaxel is the Company’s newest clinical-stage small molecule. As a late Phase 2 oncology product, tesetaxel is the leading oral taxane currently in clinical development. The new trial builds on more than ten years of Genta’s experience in melanoma clinical research.

Cardium Reports on Registered Direct Offering

Tue, 9 Mar 2010

SAN DIEGO, March 9, 2010 /PRNewswire via COMTEX/ -- Cardium Therapeutics, Inc. (NYSE Amex: CXM) today announced that it has entered into agreements with certain institutional investors to sell $5.0 million out of its proposed $10 million registered direct offering. The balance of the registered direct offering is expected to be confirmed by additional investors on or around March 12, 2010 resulting in aggregate gross offering proceeds to Cardium of up to approximately $10 million, before deducting placement agent fees and offering expenses. Cardium expects to use the proceeds from the offering for general corporate purposes.

Exelixis Announces Restructuring

Mon, 8 Mar 2010

SOUTH SAN FRANCISCO, Calif., Mar 08, 2010 (BUSINESS WIRE) -- Exelixis, Inc. (Nasdaq:EXEL) today announced a restructuring as a consequence of its continued strategy to focus resources on the development of its key late-stage compounds. As its first priority, the company will aggressively advance XL184, XL147 and XL765, each of which is the subject of a large clinical development program. Additionally, Exelixis retains a fully integrated R&D organization, and will continue to advance new compounds into development, although the number will be reduced for the foreseeable future. Exelixis has retained the ability to meet all of its obligations to existing partners. Further, as a result of its retained R&D capabilities and its numerous unpartnered clinical and preclinical compounds, the company expects that its ongoing and future business development discussions will be unaffected.

Cardium's Exchange Listing Compliance Plan Accepted by NYSE AMEX

Mon, 8 Mar 2010

SAN DIEGO, March 8, 2010 /PRNewswire via COMTEX/ -- Cardium Therapeutics (NYSE AMEX: CXM) reported that its exchange listing compliance plan submitted on January 26, 2010 has been accepted by the NYSE AMEX LLC (formerly the American Stock Exchange).

Genta Inc. Announces $25 Million Financing

Mon, 8 Mar 2010

BERKELEY HEIGHTS, NJ – March 8, 2010 – Genta Incorporated (OTCBB: GETA) announced today that the Company has entered into definitive agreements with institutional investors for a private placement of Convertible Notes totaling $25 million in gross proceeds. The transaction is expected to close on or about March 10, 2010, subject to the satisfaction of customary closing conditions. Proceeds of the financing will be used to ensure adequate followup to determine overall survival results from Genta’s recently completed Phase 3 trial of Genasense® (oblimersen sodium) Injection plus chemotherapy as first-line treatment of patients with advanced melanoma (known as AGENDA) and to accelerate development of the Company’s pipeline products, among other uses.

Poniard Pharmaceuticals Presents Positive Survival Data from a Phase 2 Clinical Study of Picoplatin in Metastatic Prostate Cancer at the 2010 American Society of Clinical Oncology Genitourinary Cancers Symposium

Fri, 5 Mar 2010

SOUTH SAN FRANCISCO, Calif., March 5, 2010 /PRNewswire via COMTEX/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on innovative oncology therapies, today announced the presentation of positive final data, including survival data, from the Company's Phase 2 clinical trial of picoplatin as a first-line therapy in men with metastatic castration-resistant (hormone-refractory) prostate cancer (CRPC). The results were presented in a General Poster Session today at the 2010 American Society of Clinical Oncology's Genitourinary Cancers Symposium in San Francisco, CA.

RITA NEWS: La Jolla Pharmaceuticals Removed from Rita Biotech Stock Index Following Delisting From Nasdaq

Fri, 5 Mar 2010

As of March 4th, 2010 La Jolla Pharmaceuticals (LJPC) is no longer a part of the Rita Biotech Stock Index. The company delisted from Nasdaq following a failed merger attempt with Adamis Pharmaceuticals Corporation. Please view the press release for more information on this delisting.

Neurocrine Biosciences Inc. Prices Common Stock Offering

Fri, 5 Mar 2010

SAN DIEGO, March 5, 2010 /PRNewswire via COMTEX/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the pricing of an underwritten public offering of 9,100,000 shares of its common stock at a price to the public of $2.20 per share. The gross proceeds from the sale of the shares, before underwriting discounts and commissions and other offering expenses, are expected to be approximately $20 million. The offering is expected to close on or about March 10, 2010, subject to customary closing conditions.

Neurocrine Announces Proposed Public Offering of Common Stock

Thu, 4 Mar 2010

SAN DIEGO, March 4, 2010 /PRNewswire via COMTEX/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that it is offering to sell shares of its common stock in an underwritten public offering. Jefferies & Company, Inc. is the sole book-running manager for this offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Raptor Pharmaceutical Announces Publication of Data Supporting Potential Efficacy of WntTide(TM) in Treatment of Triple-Negative Breast Cancer

Thu, 4 Mar 2010

NOVATO, Calif., Mar 4, 2010 (GlobeNewswire via COMTEX) -- Raptor Pharmaceutical Corp. ("Raptor" or the "Company") (Nasdaq:RPTP) today announced the publication of data on a proprietary, Mesd (Mesoderm development)-based peptide, also known as WntTide(TM), licensed by Raptor from Washington University in St. Louis, in the March 1 Early Addition of Proceedings of the National Academy of Sciences. The paper, titled, "LRP6 Overexpression Defines a Class of Breast Cancer Subtype and Is a Target for Therapy," presents findings from studies conducted by the lab of Dr. Guojun Bu, the inventor of the peptide, and Professor of Pediatrics, Cell Biology and Physiology at Washington University in St. Louis.

La Jolla Pharmaceutical Announces Delisting from Nasdaq and Failure to Get Stockholder Vote for Merger

Wed, 3 Mar 2010

SAN DIEGO--(EON: Enhanced Online News)--La Jolla Pharmaceutical Company today announced that it received notification from the Nasdaq Hearings Panel that the Panel has determined to deny the Company's request for continued listing on The Nasdaq Stock Market and that trading of the Company's common stock will be suspended effective at the open of business on Thursday, March 4, 2010. The Panel determined that the Company is operating as a "public shell" because of the Company's nominal assets, other than cash, and the Company's nominal operations.

GenVec: New Research Reveals Mechanism By Which TNFerade™ Suppresses Metastases

Wed, 3 Mar 2010

GAITHERSBURG, Md., March 3 /PRNewswire-FirstCall/ -- GenVec, Inc. (Nasdaq: GNVC) announced the publication of new preclinical research revealing mechanisms by which TNFerade(TM) suppresses cancer metastases through activation of the immune system.

Seattle Genetics Achieves Milestone under Antibody-Drug Conjugate Collaboration with Genentech

Wed, 3 Mar 2010

BOTHELL, Wash., Mar 03, 2010 (BUSINESS WIRE) -- Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that it has achieved a milestone under its antibody-drug conjugate (ADC) collaboration with Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY). The milestone was triggered by Genentech's submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for an ADC utilizing Seattle Genetics' technology for the treatment of cancer.

CombiMatrix Corporation Retires All Remaining Convertible Debt

Wed, 3 Mar 2010

MUKILTEO, Wash., Mar 3, 2010 (GlobeNewswire via COMTEX News Network) -- CombiMatrix Corporation (Nasdaq:CBMX) announced today that it has fully repaid the secured convertible debenture held by YA Global Investments, L.P., which had an original principal amount of $10.0 million. As a result of retiring this debt, the potentially dilutive reserve of approximately 1.1 million shares of common stock that could have been issued from conversion of the remaining debt was also retired.

Pluristem Therapeutics Receives DSMB Approval to Advance to Final Dose Level with PLX-PAD

Tue, 2 Mar 2010

HAIFA, Israel, March 2, 2010 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI - News) (DAX:PJT) today announced that it has received approval from an independent Data Safety Monitoring Board (DSMB) to advance to the highest and final dose level with its placenta-derived cell therapy product, PLX-PAD, in a Phase I dose-escalating clinical trial in Europe for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD).

Dyax's KALBITOR (ecallantide) Data Presented at American Academy of Allergy, Asthma and Immunology Annual Meeting

Tue, 2 Mar 2010

Results of KALBITOR Efficacy for HAE Acute Attacks by Attack Location

CAMBRIDGE, Mass., Mar 02, 2010 (BUSINESS WIRE) -- Datademonstrating the effectiveness of KALBITOR (ecallantide) to treat hereditary angioedema (HAE) acute attacks by primary attack location were provided in an oral presentation yesterday at the American Academy of Allergy, Asthma and Immunology (AAAAI) 2010 Annual Meeting in New Orleans. KALBITOR, discovered and developed by Dyax Corp. (NASDAQ:DYAX), was approved by the U.S. Food and Drug Administration (FDA) late last year and is indicated for the treatment of acute attacks of HAE in patients 16 years of age or older.

GTC Provides Update on TG20 Monoclonal Antibody Targeting CD20

Mon, 1 Mar 2010

FRAMINGHAM, MA – March 1, 2010 -- GTC Biotherapeutics, Inc. (“GTC”, NASDAQ: GTCB) announced that it has achieved high-level production of TG20; an anti-CD20 monoclonal antibody (MAb). The TG20 MAb, which is produced in the milk of transgenic goats, is being co-developed by GTC and LFB as part of the LFB-GTC joint venture. TG20 has enhanced antibody-dependent cell-mediated cytotoxicity (ADCC), a key feature useful in the treatment of cancer and auto-immune diseases, and it has been shown to have 10-fold enhanced ADCC when compared side by side with rituximab in assays performed with B-cell chronic lymphocytic leukemia, or B-CLL, patient cancer cell isolates.

ARIAD Receives Orphan Drug Designations for Its Investigational pan BCR-ABL Inhibitor, AP24534, in Chronic Myeloid Leukemia

Mon, 1 Mar 2010

CAMBRIDGE, Mass., Mar 01, 2010 (BUSINESS WIRE) -- ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that its investigational pan-BCR-ABL inhibitor, AP24534, has been granted orphan drug designation by both the U. S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). In the U.S., the orphan designation of AP24534 is for the treatment of chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) and in the E.U., its orphan designation is for CML and acute lymphoblastic leukemia.

Agennix AG Announces Longer-Term Mortality Results from Talactoferrin Phase 2 Trial in Severe Sepsis

Fri, 26 Feb 2010

Trial results show effect of talactoferrin on reduction in mortality is sustained at three months and six months

Martinsried/Munich (Germany), Princeton, NJ and Houston, TX, February 26, 2010 – Agennix AG (Frankfurt Stock Exchange: AGX) today announced longer-term mortality results from the talactoferrin randomized, double-blind, placebo-controlled Phase 2 trial in severe sepsis. The trial evaluated talactoferrin versus placebo in 190 adult patients with severe sepsis enrolled at 25 leading centers across the U.S. Patients in both arms received standard of care treatment for severe sepsis in an intensive care unit (ICU) setting. As previously reported, the trial achieved its primary endpoint of a reduction in 28-day all-cause mortality. The results announced today showed that talactoferrin also reduced all-cause mortality compared to placebo over the longer term - at three months and at six months.

Cleveland BioLabs Raises $5 Million From Institutional Investors Through Private Placement

Fri, 26 Feb 2010

BUFFALO, NY, Feb 26, 2010 (MARKETWIRE via COMTEX) -- Cleveland BioLabs, Inc. (NASDAQ: CBLI) (the "Company") announced today that it has signed an agreement with various institutional investors for the private placement of an aggregate of 1,538,462 shares of its common stock and warrants to purchase 1,015,385 shares of its common stock for an aggregate purchase price of $5,000,000, or $3.25 per share. The warrants are exercisable commencing six months following issuance, have a term of exercise of 4.5 years and an exercise price of $4.50. The shares issued to the investors and the shares underlying the warrants have not been and will not be registered under the Securities Act of 1933, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

Genta Initiates Once-Weekly Treatment Schedule for Tesetaxel, a Novel Oral Tubulin Inhibitor, in New Dose-Ranging Study

Thu, 25 Feb 2010

BERKELEY HEIGHTS, N.J.--(BUSINESS WIRE)--Genta Incorporated (OTCBB: GETA) announced that the Company has initiated a new dose-ranging study of tesetaxel, the Company’s novel oral tubulin inhibitor, using a weekly dosing regimen. Tesetaxel -- a late Phase 2 oncology product -- is the leading oral taxane currently in clinical development.

MorphoSys AG Reports Positive Results for Fiscal Year 2009

Thu, 25 Feb 2010

MorphoSys AG (FSE: MOR; Prime Standard Segment; TecDAX) today announced its financial results according to International Financial Reporting Standards (IFRS) for the three-months' period and financial year ending December 31, 2009. The Company increased full-year Group revenues by 13 % to EUR 81.0 million (2008: EUR 71.6 million). Operating profit amounted to EUR 11.4 million (2008: EUR 16.4 million). The year-on-year decrease was a direct result of the planned increased investment in proprietary development in the amount of EUR 19.3 million in 2009 (up from EUR 8.9 million in 2008). Group net profit after taxes decreased to EUR 9.0 million (2008: EUR 13.2 million) due to the higher level of R&D investment. At the end of the year 2009, MorphoSys's cash position amounted to EUR 135.1 million (2008: EUR 137.9 million).

Dynavax Selects Clinical Candidate in Universal Flu Vaccine Program

Thu, 25 Feb 2010

BERKELEY, CA, Feb 25, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that it has selected a clinical vaccine candidate for its novel Universal Flu program, completed key preclinical studies, and is reviewing clinical plans with the FDA in anticipation of initiating a Phase I study by mid-year. Dynavax also said that the trial will be conducted at centers that are members of the Vaccine Testing and Evaluation Units (VTEUs) of the National Institute for Allergy and Infectious Disease (NIAID/NIH). Specifically, Dynavax will collaborate with Dr. Robert B. Belshe, Principal Investigator of the VTEU at St. Louis University in St. Louis, MO and with Dr. Wendy A. Keitel, Principal Investigator, of the VTEU at Baylor University in Houston, TX. Dynavax made its comments today in connection with a Workshop on Influenza Vaccinology sponsored by the President's Council of Advisors on Science and Technology in Washington, D.C.

Cleveland BioLabs Submits Response to Department of Defense Request for Proposal for Radiation Countermeasure

Wed, 24 Feb 2010

Hosts Press Conference to Discuss Business and Clinical Updates

BUFFALO, NY, Feb 24, 2010 (MARKETWIRE via COMTEX) -- Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that it has submitted a response to the Request for Proposal (RFP) issued by The Department of Defense (DoD) for the advanced development, Food and Drug Administration (FDA) approval/licensure and delivery of Medical Radiation Countermeasure (MRC).

La Jolla Pharmaceutical Company (LJPC) Provides Voting Update - More Votes Needed or La Jolla Will Likely Close

Wed, 24 Feb 2010

SAN DIEGO--(BUSINESS WIRE)--La Jolla Pharmaceutical Company today provided an update on the Company’s upcoming special meeting of stockholders on February 26, 2010 at 3:00 p.m. Pacific Time to vote on its proposed merger with Adamis Pharmaceuticals Corporation (OTCBB: ADMP - News).

Transgenomic Licenses IP From IntegraGen to Develop Genetic Test for Autism

Wed, 24 Feb 2010

OMAHA, Neb., Feb. 24 /PRNewswire-FirstCall/ -- Transgenomic, Inc. (OTC Bulletin Board: TBIO) announced today that it has licensed on an exclusive U.S. basis intellectual property from IntegraGen SA that will enable Transgenomic to develop and commercialize a genetic test designed to assess the risk of autism in children who have older siblings diagnosed with an autism spectrum disorder. Under the agreement Transgenomic will develop the test in the Company\'s CAP-accredited and CLIA-certified laboratory, and anticipates launching the new test in the second quarter of 2010. Financial terms of the agreement were not disclosed.

Poniard Pharmaceuticals Secures $20 Million Committed Equity Financing Facility

Wed, 24 Feb 2010

SOUTH SAN FRANCISCO, Calif., Feb 23, 2010 /PRNewswire via COMTEX News Network/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on innovative oncology therapies, today announced that it has entered into a committed equity financing facility under which it may sell up to $20 million of its registered common stock to Commerce Court Small Cap Value Fund, Ltd. over an approximately 18-month period. Poniard is not obligated to utilize any of the facility and remains free to enter into other financing transactions.

Idera Pharmaceuticals Presents Mechanism of Action Data on IMO-3100, a Novel Toll-like Receptor Antagonist for Autoimmune Diseases, at Keystone Symposium

Tue, 23 Feb 2010

CAMBRIDGE, Mass., Feb 23, 2010 (BUSINESS WIRE) -- Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) today presented data on the mechanism of action of IMO-3100, an antagonist of Toll-like Receptor (TLR) 7 and TLR9, in a preclinical primate model at the Keystone Symposia conference "Tolerance and Autoimmunity" being held February 21-26 in Taos, New Mexico. Idera is developing IMO-3100 for the treatment of autoimmune diseases. The presentation entitled "IMO-3100, a novel antagonist, suppresses TLR7- and TLR9-mediated immune responses in non-human primates" was made by Idera scientists. The data presented showed that subcutaneous administration of IMO-3100 suppressed TLR7- and TLR9-mediated immune responses in primates, reducing production of cytokines such as tumor necrosis factor-alpha (TNF-a), interferon-alpha (IFN-a), IP-10, and IL-6.

MorphoSys AG: AbD Serotec Significantly Improves Antibody Generation Process

Tue, 23 Feb 2010

utomation and HuCAL PLATINUM Support Increase in Success Rates to 98%

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) today announced that its research and diagnostic antibody unit AbD Serotec has demonstrated significant progress using the HuCAL-based technology platform to generate custom-made monoclonal antibodies for research and diagnostic use. Over the course of the last four years, AbD Serotec gradually improved success rates year-on-year starting at 80% in 2006 to reach 98% in 2009. This was mainly achieved through a high degree of automation in many aspects of the antibody generation process, by optimizing protocols and finally by the implementation of HuCAL PLATINUM, the latest and most powerful version of MorphoSys's antibody libraries.

GTC Enters into Agreement to Receive $7 Million in Financing From LFB

Mon, 22 Feb 2010

FRAMINGHAM, MA February 22, 2010 -- GTC Biotherapeutics, Inc. (GTC, NASDAQ: GTCB) announced that it has entered into an agreement with its strategic partner, LFB Biotechnologies (Les Ulis, France), pursuant to which LFB has agreed to provide $7 million of new loan financing to GTC. The financing will be in the form of a 4%, 36-month secured term loan with a single payment of principle and interest at maturity. The transaction is expected to close on February 24, 2009 and is subject to customary closing conditions.

NasVax and Novartis Announce Joint Research & Option for License Agreement

Mon, 22 Feb 2010

21 February, 2010 NasVax Ltd (TASE: NSVX) is pleased to announce that it entered into a Joint Research and Option for License Agreement (the "Agreement") with Novartis Vaccines and Diagnostics Srl. ("Novartis"), in which the parties will jointly investigate the feasibility of developing improved vaccines through incorporation of the Company's adjuvant technology (VaxiSomeTM), among which is an improved vaccine for Influenza (including Swine Flu). The Company also granted Novartis an option to acquire a non-exclusive license to use VaxiSome in connection with certain of Novartis' vaccines.

Ablynx Receives €1.2 Million Grant to Further Advance Its ANTI-IL-6R Program, ALX-0061

Fri, 19 Feb 2010

GHENT, Belgium, 19 February 2010 - Ablynx [Euronext Brussels: ABLX], announced today that it has been awarded a grant worth €1.2 million by the Flemish agency for Innovation by Science and Technology (IWT).

The grant supports Ablynx in accelerating the development of its Nanobody-based programme, ALX-0061, into clinical development for the treatment of autoimmune and inflammatory diseases.

GenVec Announces Contract With The Department of Homeland Security

Fri, 19 Feb 2010

GAITHERSBURG, Md., Feb. 19 /PRNewswire-FirstCall/ -- Today GenVec, Inc. (Nasdaq: GNVC) announced a new contract with the Department of Homeland Security (DHS) to continue the development of adenovector-based vaccines against foot-and-mouth disease (FMD) based on research and development done in collaboration with USDA-ARS and DHS S&T scientists at the Plum Island Animal Disease Center. Under this new agreement, GenVec will receive $3.8 million in program funding the first year and an additional $0.7 million if DHS exercises its renewal option under the contract.

MorphoSys and Galapagos Expand Antibody Alliance

Thu, 18 Feb 2010

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) and Galapagos NV (Euronext: GLPG) announce that they have expanded their antibody alliance in bone and joint diseases. Based on the solid progress made so far, the partners have agreed to add another antibody target to the alliance, thereby increasing the total number of programs to four.

Dynavax and GlaxoSmithKline Select Clinical Candidate in the Endosomal TLR Inhibitor Program

Thu, 18 Feb 2010

BERKELEY, CA, Feb 18, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced the selection of a candidate for clinical development in its endosomal Toll-like Receptor (TLR) inhibitor collaboration with GlaxoSmithKline. The selected molecule DV1179, a bifunctional TLR inhibitor, has moved into advanced preclinical IND-enabling studies that could allow clinical development to begin as early as this year. Dynavax and GlaxoSmithKline are collaborating to develop novel inhibitors of endosomal TLRs for the treatment of multiple autoimmune and inflammatory diseases. TLRs are key receptors of the innate immune system.

BioMimetic Therapeutics Completes Submission of PMA Application for FDA Approval of Augment™ Bone Graft

Wed, 17 Feb 2010

FRANKLIN, Tenn., Feb 17, 2010 (BUSINESS WIRE) -- BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today announced it has submitted the third and final module of its Premarket Approval (PMA) application for marketing of Augment(TM) Bone Graft in the U.S. This final module, containing a comprehensive review of the clinical data related to Augment, completes the PMA application to the FDA. The Company previously announced the filing of both the pre-clinical pharmacology/toxicology and quality/manufacturing modules with the FDA in June of 2009. Upon receipt of the clinical module, the FDA begins its 45 day filing process as the first step in the formal review of the PMA. The Company expects the agency to schedule an advisory panel review sometime later in the year.

Dynavax Receives Canadian Approval to Conduct Phase 3 Trials of HEPLISAV(TM)

Tue, 16 Feb 2010

BERKELEY, CA, Feb 16, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced that Health Canada, the Canadian equivalent of the U.S. Food and Drug Administration, has approved the initiation of the Company's next Phase 3 trials in Canada. Initiation of the Canadian studies is expected to facilitate enrollment for the multi-center trials. Immunizations in the U.S. have begun, while the Canadian sites are expected to begin enrollment shortly. In Canada, the Health Products and Food Branch (HPFB) of Health Canada regulates the development of new drugs and vaccines.

Thallion Pharmaceuticals and LFB biotechnologies sign definitive agreement to develop and commercialize treatment for E. Coli (STEC) infection

Tue, 16 Feb 2010

Les Ulis, France and Montréal, Quebec, February 16, 2010 – Thallion Pharmaceuticals Inc. (‘‘Thallion’’) (TSX: TLN) and LFB Biotechnologies (‘‘LFB’’) today announced the signing of a definitive development and commercialization agreement for Shigamabs®, Thallion’s product candidate for the treatment of Shiga toxin-producing E. coli, or STEC, infections. Thallion has granted LFB, an affiliate of the Laboratoire français du Fractionnement et des Biotechnologies of Les Ulis, France, an exclusive license for the commercial rights to Shigamabs® in Europe, South America and other territories of strategic interest to LFB, including Russia, Turkey, China, South Korea and Northern African countries. Thallion retains commercial rights for the rest of world, including North America. The agreement follows the binding Letter of Intent signed in December 2009 between the two parties.

EntreMed Receives Orphan Drug Designation for ENMD-2076 in Leukemia

Tue, 16 Feb 2010

ROCKVILLE, MD, February 16, 2010 – EntreMed, Inc. (Nasdaq: ENMD), today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the Company’s lead oncology drug candidate, ENMD-2076, for the treatment of acute myeloid leukemia (AML).

StemCells, Inc. Launches Cell Culture Medium Enabling the Derivation and Maintenance of True Mouse iPS Cells

Tue, 16 Feb 2010

PALO ALTO, Calif., Feb 16, 2010 (GlobeNewswire via COMTEX) -- StemCells, Inc. (Nasdaq:STEM) announced today the launch of GS2-M(TM), a new cell culture medium that enables the derivation and long-term maintenance of true (germline competent) mouse induced pluripotent stem (iPS) cells. GS2-M, the latest addition to the Company's growing SC Proven(R) line of specialty cell culture products, has been shown to increase the efficiency of reprogramming 'pre-iPS' cells to derive fully pluripotent stem cells, and to maintain mouse iPS cells in a definitive pluripotent state in long-term culture.1,2

Cardium Announces Agreement With bioRASI to Advance and Broaden Clinical Development of Generx Product Candidate

Tue, 16 Feb 2010

SAN DIEGO, Feb. 16 /PRNewswire-FirstCall/ -- Cardium Therapeutics (NYSE Amex: CXM) today announced that it has entered into an agreement with bioRASI, an international contract research organization, to assist Cardium in the evaluation of Generx clinical development opportunities within major newly-industrializing markets in Eastern Europe, Asia and Latin America, for patients with chronic coronary artery disease who are either not optimal candidates for or do not have access to costly angioplasty/stenting or cardiac bypass surgery procedures.

AstraZeneca and Rigel Pharmaceuticals Sign Worldwide License Agreement for Late-Stage Development Product -- Fostamatinib Disodium (R788) -- for the Treatment of Rheumatoid Arthritis (RA)

Tue, 16 Feb 2010

SOUTH SAN FRANCISCO, Calif., Feb 16, 2010 /PRNewswire via COMTEX/ -- AstraZeneca and Rigel Pharmaceuticals (Nasdaq: RIGL) today announced an exclusive worldwide license agreement for the global development and commercialization of fostamatinib disodium (R788), Rigel's late-stage investigational product for rheumatoid arthritis (RA) and additional indications. Fostamatinib disodium, which has completed a comprehensive phase 2 program, is the furthest developed oral Spleen Tyrosine Kinase (Syk) inhibitor being evaluated for RA. Inhibiting Syk is thought to block the intracellular signaling of various immune cells implicated in the destruction of bone and cartilage which is characteristic of RA.

Celldex Receives $3 Million Sublicense Income Payment from TopoTarget

Tue, 16 Feb 2010

NEEDHAM, Mass., Feb 16, 2010 (BUSINESS WIRE) -- Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced that it has received a sublicense income payment of $3 million from TopoTarget A/S (NASDAQ-OMX: TOPO.CO) as a result of the recent co-development and commercialization agreement between TopoTarget and Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) for Belinostat, a novel histone deacetylase (HDAC) inhibitor for the treatment of cancer. In this transaction, TopoTarget granted Spectrum a license for the co-development and commercialization of Belinostat in North America and India, with an option for the Chinese rights, in exchange for an upfront cash payment of $30 million.

AVI BioPharma Receives Grants Totaling $500,000 from CureDuchenne and the Foundation to Eradicate Duchenne to Support Continuing Development of Drug Candidates to Treat Duchenne Muscular Dystrophy

Mon, 15 Feb 2010

BOTHELL, WA — February 15, 2010 — AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based drugs, today announced that CureDuchenne and the Foundation to Eradicate Duchenne (FED), each awarded grants of $250,000 to AVI BioPharma to support continued research and development of the Company’s exon skipping drug candidates for the treatment of Duchenne Muscular Dystrophy (DMD), a genetic muscle wasting disease caused by failure to produce dystrophin. Cure Duchenne and FED are US not-for-profit foundations fully dedicated to supporting the research and development of a cure for DMD.

Idera Pharmaceuticals Presents Preclinical Hyperlipidemia Data on a Toll-like Receptor Antagonist at Keystone Symposium

Mon, 15 Feb 2010

CAMBRIDGE, Mass., Feb 14, 2010 (BUSINESS WIRE) -- Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) presented data on the evaluation of a Toll-like receptor (TLR) antagonist in a preclinical hyperlipidemia model today at the Keystone Symposia conference "Advances in Molecular Mechanisms of Atherosclerosis" being held in Banff, Alberta, Canada. Idera's proprietary TLR antagonists have dual activity for both TLR7 and TLR9, and present a potentially innovative approach for the treatment of certain autoimmune diseases. The presentation, entitled "Control of atherogenic lipids by a novel antagonist of TLR7 and 9 in mouse models of hyperlipidemic disease" (abstract #208), was made by Idera scientists. In the studies presented, a dual antagonist of TLR7 and TLR9 was evaluated in mice fed a high-fat diet to induce hyperlipidemia. Treatment with the antagonist resulted in reduced serum total cholesterol, LDL-cholesterol, leptin, hepatic and kidney steatosis, and body weight gain compared to control mice on high-fat diet.

Ablynx Wins Patent Opposition Case Against Domantis (GSK)

Thu, 11 Feb 2010

GHENT, Belgium, 11 February 2010 - Ablynx [Euronext Brussels: ABLX] announced today that it has selected a new GPCR targeting development candidate, ALX-0651, an anti-CXCR4 Nanobody which is being developed for hematopoietic stem cell mobilisation. The Company is also releasing new data on pulmonary to systemic administration and needle-free administration of Nanobodies. Ablynx will present an update of its therapeutic pipeline and its recent technology advances at its R&D Investor Update in New York, USA tomorrow at 8.00 a.m. EST.

Ablynx Selects GPCR Targeting Development Candidate, Announces New Data on Alternative Routes of Delivery For Nanobodies and Provides an R&D Update

Thu, 11 Feb 2010

New Scientific Publication Highlights Long-Term Survival of Brain Cancer Patients Treated With Peregrine Pharmaceuticals' Cotara

Thu, 11 Feb 2010

Article in Current Cancer Therapy Reviews Reports on GBM Patients Who Have Survived More than Nine Years after Treatment with Cotara-

TUSTIN, Calif., Feb 11, 2010 /PRNewswire via COMTEX News Network/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) today reported publication of data in the online edition of the journal Current Cancer Therapy Reviews that supports the clinical potential of the company's novel brain cancer agent Cotara(R) for the treatment of patients with glioblastoma multiforme (GBM), the deadliest form of brain cancer.(1) Cotara specifically targets cells at the center of brain tumors, so its radioactive payload is able to kill cancer cells while leaving healthy tissue largely unaffected. Cotara is currently being tested in a Phase II clinical trial in recurrent GBM patients.

Advanced Life Sciences Previews 2010 Milestones

Wed, 10 Feb 2010

Major Initiatives Underway in Community, Biodefense and Hospital Settings

CHICAGO, Feb 09, 2010 /PRNewswire via COMTEX/ -- Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, is providing a preview of its priorities and anticipated milestones for 2010 based on a foundation of progress and strengthened strategic focus achieved in 2009.

Agennix AG Announces U.S. Class Action Lawsuit Against Predecessor GPC Biotech AG Fully Closed

Wed, 10 Feb 2010

Martinsried/Munich (Germany), Princeton, NJ and Houston, TX, February 10, 2010 – Agennix AG (Frankfurt Stock Exchange: AGX) today announced that the class action lawsuit brought against its predecessor, GPC Biotech AG, in the United States District Court for the Southern District of New York, is now fully closed.

StemCells, Inc. Announces First Human Neural Stem Cell Transplant in Landmark Myelination Disorder Trial

Wed, 10 Feb 2010

PALO ALTO, Calif., Feb 10, 2010 (GlobeNewswire via COMTEX) -- StemCells, Inc. (Nasdaq:STEM) announced today that its proprietary HuCNS-SC(R) human neural stem cells have been used to treat the first patient enrolled in its Phase I clinical trial in Pelizaeus-Merzbacher Disease (PMD), a myelination disorder that afflicts male children. The stem cells were administered yesterday at the University of California, San Francisco (UCSF) Children's Hospital by direct injection into the brain of a patient with connatal PMD, the most severe form of the disease. This marks the first time that neural stem cells have been transplanted as a potential treatment for a myelination disorder, and the second clinical trial involving the use of HuCNS-SC cells in a neurodegenerative disease.

AbD Serotec Expands Sales Office in Düsseldorf to Support Future Growth

Tue, 9 Feb 2010

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today that its research and diagnostic antibodies unit AbD Serotec will expand its sales organization in Düsseldorf to support growth in continental and eastern Europe as well as in Asia. Today's official opening ceremony was performed by Friedrich G. Conzen, major of Düsseldorf.
Dr. Simon Moroney, Chief Executive Officer of MorphoSys Group, also attended along with Dieter Feger, Head of AbD Serotec. The expanded Düsseldorf office will coordinate global sales activities of AbD Serotec outside North, Central and South America.

Dynavax Initiates Large-Scale Phase 3 Trial of HEPLISAV™

Tue, 9 Feb 2010

BERKELEY, CA, Feb 08, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today initiation of a large-scale Phase 3 trial designed to demonstrate the lot-to-lot consistency of commercial vaccine and to complete the safety database for HEPLISAV(TM), the Company's investigational adult hepatitis B vaccine. This study and the ongoing Phase 3 trial in chronic kidney disease patients are directed toward fulfilling licensure requirements in the U.S., Canada and Europe. HEPLISAV has been shown in two pivotal Phase 3 trials to enhance protection more rapidly and with fewer doses than a currently licensed vaccine.

Transgenomic Demonstrates Very High Sensitivity Detection of Tumor-Associated KRAS Mutations in Matched Plasma Samples using COLD-PCR

Mon, 8 Feb 2010

OMAHA, Neb., Feb. 8 /PRNewswire-FirstCall/ -- Transgenomic, Inc. (OTC Bulletin Board: TBIO) announced today that it has completed a preliminary study with a leading pharmaceutical company that validates the use of its licensed COLD-PCR technology to detect colorectal tumor-associated KRAS mutations that determine efficacy of recently developed therapies. These were detected in plasma samples in which the mutation levels were too low for detection by standard DNA analysis methodologies such as Sanger sequencing.

RITA NEWS: Ten Companies Delisted From Rita Biotech Stock Index

Mon, 8 Feb 2010

As of Monday, February 8, the following companies are no longer included in the Rita Biotech Stock Index due to trading consistently under $0.10:

ProtoKinetix, Inc.
Nanogen, Inc.
Genitope Corporation
Panacos Pharmaceuticals
InNexus Biotechnology
Benitec Ltd.
Incitive Limited
Migenix Inc.
OSMETECH PLC
Adherex Technologies Inc.

These changes reflect the index's mission to be comprised of early-stage but active biotech stocks. Rita will continue to provide updates for any changes made to the index.

Sunesis Grants Carmot Therapeutics License to Its Drug Discovery Technology

Mon, 8 Feb 2010

SOUTH SAN FRANCISCO, CA, Feb 08, 2010 (MARKETWIRE via COMTEX News Network) -- Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today announced that it has granted Carmot Therapeutics, Inc., a privately-held biotechnology company, an exclusive license to its proprietary Fragment-Based Lead Discovery (FBLD) technology. Carmot will use the FBLD technology, called "Chemotype Evolution," for identifying promising drug candidates in a broad range of therapeutic areas, including inflammatory, metabolic, and neurodegenerative diseases. Sunesis retains full rights to the technology for use in its future internal discovery efforts. Terms of the agreement were not disclosed.

Neurocrine Biosciences Announces the Appointment of William H. Rastetter to Its Board of Directors

Mon, 8 Feb 2010

SAN DIEGO, Feb 08, 2010 /PRNewswire via COMTEX/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that it has appointed William H. Rastetter Ph.D. to its Board of Directors effective immediately. He is the current Chairman and Chief Executive Officer of Receptos, Inc., and former Executive Chairman of Biogen Idec, Inc.

Access Pharmaceuticals initiates Cobalamin technology program for targeted delivery of siRNA therapies

Mon, 8 Feb 2010

ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP) announced today that it initiated an internal pre-licensing program to confirm the utility of its proprietary Cobalamin (vitamin B12) platform technology for targeted delivery of siRNA therapies. The program is considered important because, despite the widely publicized potential of RNA therapy, researchers up to now have been stymied in their efforts to design a pharmaceutical product that efficiently transports siRNA therapeutics into the cells they are designed to inhibit or kill.

AVI BioPharma's Drug Candidate AVI-5038 Receives European Orphan Drug Designation For Duchenne Muscular Dystrophy

Fri, 5 Feb 2010

BOTHELL, WA — February 5, 2010 — AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based drugs, today announced that it received an orphan drug designation from the Committee for Orphan Medical Products of the European Medicines Agency (EMEA) for AVI-5038, a drug candidate being developed by AVI for the treatment of Duchenne Muscular Dystrophy (DMD). DMD is a genetic muscle wasting disease caused by failure to produce dystrophin. The orphan drug designation potentially may provide AVI up to 10 years of market exclusivity if the drug candidate is approved for marketing in the European Union (EU). AVI-4658, another drug being developed by AVI for DMD, received European orphan drug designation in 2008, and also potentially may receive up to 10 years of marketing exclusivity if approved in the EU.

Access Pharmaceuticals announces closing of $6.3 million in registered direct offering

Thu, 4 Feb 2010

ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP), today announced that it closed its previously announced sale of approximately 2.10 million shares of its common stock and warrants to purchase approximately 1.05 million shares of its common stock for gross proceeds of approximately $6.3 million onJanuary 22, 2010. Access sold the shares and warrants for $3.00per unit (each unit consisting of one share and a warrant to purchase 0.5 shares of common stock). The exercise price of the warrants is $3.00 per share.

AVI BioPharma GLP Safety Pharmacology and Genotoxicity Evaluations of AVI-4658 for Duchenne Muscular Dystrophy Published in the International Journal of Toxicology

Thu, 4 Feb 2010

BOTHELL, WA -- (Marketwire) -- 02/04/10 -- AVI BioPharma, Inc (AVII), a developer of RNA-based drugs, today announced that the results and scientific findings of Good Laboratory Practice (GLP)-compliant safety pharmacology and genotoxicity evaluations of AVI-4658, a drug candidate being developed by AVI for the treatment of Duchenne Muscular Dystrophy (DMD), were published online in the International Journal of Toxicology. The publication, "Safety Pharmacology and Genotoxicity Evaluation of AVI-4658," reports that the GLP-compliant preclinical studies revealed no study related effects on health status, even when dosed at the maximum feasible dose, and there were no reports of injection site reactions. It was also reported that the genotoxicity evaluation of AVI-4658 revealed no genotoxic potential, even at very high concentrations. These results suggest AVI-4658 may have a wide therapeutic window for chronic dosing and supported the initiation of the Phase 1b/2 clinical trial of AVI-4658 that is ongoing in the United Kingdom.

Poniard Pharmaceuticals Announces Management Changes and Reduction in Force

Wed, 3 Feb 2010

SOUTH SAN FRANCISCO, Calif., Feb 03, 2010 /PRNewswire via COMTEX News Network/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on innovative oncology therapies, today announced that Ronald A. Martell has been appointed to the position of chief executive officer, succeeding Jerry McMahon, Ph.D., who will remain as non-executive chairman of the Board of Directors. In addition, Michael S. Perry, DVM, Ph.D., has been named president and chief medical officer.

Seattle Genetics and Millennium Announce Initiation of Phase I Combination Clinical Trial of Brentuximab Vedotin (SGN-35) for Front-line Hodgkin Lymphoma

Wed, 3 Feb 2010

BOTHELL, Wash., Feb 03, 2010 (BUSINESS WIRE) -- Seattle Genetics, Inc. (Nasdaq: SGEN) and Millennium Pharmaceuticals, Inc.: The Takeda Oncology Company today announced that they have initiated a phase I clinical trial of brentuximab vedotin (SGN-35) in combination with chemotherapy for the treatment of newly diagnosed Hodgkin lymphoma patients. Brentuximab vedotin is an antibody-drug conjugate (ADC) that is also in single-agent clinical trials, including a pivotal trial for relapsed and refractory Hodgkin lymphoma and a phase II trial for systemic anaplastic large cell lymphoma. The target for brentuximab vedotin is CD30, which is expressed on these hematologic malignancies. The phase I combination trial will evaluate brentuximab vedotin plus Adriamycin (doxorubicin), bleomycin, vinblastine and dacarbazine (ABVD), a commonly used front-line chemotherapy regimen for Hodgkin lymphoma.

Pluristem’s PLX Cells May Effectively Treat Ischemic Stroke - Brain Research Journal Reports

Wed, 3 Feb 2010

HAIFA, Israel--(BUSINESS WIRE)--Pluristem Therapeutics Inc. (NasdaqCM: PSTI) (DAX: PJT) today announced that the results of a pre-clinical study in an animal model of ischemic stroke demonstrated that its PLacental eXpanded (PLX) cell therapy may be an effective treatment for this disorder. Results will be published in the journal Brain Research (Brain Research, Feb. 22, Vol. 1315) under the title “Transplantation of placenta-derived mesenchymal stromal cells upon experimental stroke in rats.” The study was conducted in collaboration with the Fraunhofer Institute for Immunology and Cell Therapy (IZI) in Leipzig, Germany.

Protalix Announces NDA Submission Update for taliglucerase alfa for the Treatment of Gaucher Disease

Tue, 2 Feb 2010

CARMIEL, Israel -- Protalix BioTherapeutics, Inc. (NYSE Amex: PLX) announced today that, in connection with the New Drug Application (NDA) filed by the Company in December 2009 for taliglucerase alfa for the treatment of Gaucher disease, the U.S. Food and Drug Administration (FDA) has requested additional data regarding the Chemistry, Manufacturing and Controls (CMC) section of the NDA. No additional Clinical or Preclinical information was requested. The request focused primarily on validation of the manufacturing process in the Company's upgraded manufacturing facility. A validation plan for the Company's manufacturing process of taliglucerase alfa has already been established and reviewed by the FDA. The Company is working diligently to provide the requested data to the FDA and anticipates submitting the requested data during the second quarter of 2010.

Dyax Corp's KALBITOR(R) (ecallantide) Now Commercially Available

Tue, 2 Feb 2010

CAMBRIDGE, Mass., Feb 02, 2010 (BUSINESS WIRE) -- Dyax Corp. (NASDAQ:DYAX) announced today that KALBITOR(R) (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older is now commercially available in the United States.

HAE is a rare, genetic disorder characterized by severe, debilitating and often painful swelling, which can occur in the abdomen, face, hands, feet and airway. KALBITOR, a potent, selective and reversible plasma kallikrein inhibitor discovered and developed by Dyax, is the first subcutaneous HAE treatment approved in the U.S.

BioMimetic Therapeutics, Inc. Patent Portfolio Further Strengthened

Mon, 1 Feb 2010

Expanded EU protection for Augment(TM), Augment(TM) Injectable and GEMESIS(TM) until 2025

FRANKLIN, Tenn., Feb 01, 2010 (BUSINESS WIRE) -- BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) announced today the European Patent Office (EPO) intends to grant patent application No. 05803356 titled "Platelet-Derived Growth Factor Compositions and Methods of Use Thereof". The allowed claims cover compositions of platelet derived growth factor (PDGF) combined with matrix materials having defined characteristics, which cover the Company's novel recombinant protein-device combination product candidates, including Augment(TM)Bone Graft and Augment(TM) Injectable Bone Graft, as well as GEMESIS(TM), which the Company previously sold to Luitpold Pharmaceuticals, Inc. The new patent, which expires in 2025, will provide protection against the marketing of similar or generic versions of Augment, Augment Injectable, and GEMESIS in Europe. This notice from the EPO enhances the Company's existing, strong patent portfolio, which includes a similar patent in the United States effective through 2025.

GenVec to Present at the 12th Annual BIO CEO & Investor Conference

Mon, 1 Feb 2010

GAITHERSBURG, Md., Feb. 1 /PRNewswire-FirstCall/ -- GenVec, Inc. (Nasdaq: GNVC) today announced that Paul H. Fischer, Ph.D., GenVec's President and CEO, will present a company overview highlighting recent developments at the 12th Annual BIO CEO & Investor Conference on Monday, February 8, 2010 at 1:30 p.m. EST at the Waldorf Astoria Hotel in New York City.

Cleveland BioLabs Granted European Patent for Radiation Protection Drug CBLB502

Thu, 28 Jan 2010

BUFFALO, NY--(Marketwire - January 28, 2010) - Cleveland BioLabs, Inc. (NASDAQ: CBLI) announced today that the European Patent Office (EPO) has granted its European Patent Application Number 04813124.7l, titled "Methods of Protecting Against Radiation Using Flagellin." Allowed claims cover the method of protecting a mammal from radiation using flagellin or its derivatives, including Protectan CBLB502. The United States, nine member countries of the Eurasian Patent Organization, and two additional countries have already granted this patent.

GTC Provides Recombinant FVIIa Regulartory Update

Thu, 28 Jan 2010

FRAMINGHAM, MA – January 28, 2010 -- GTC Biotherapeutics, Inc. (“GTC”, NASDAQ: GTCB) and its strategic partner LFB Biotechnologies (Les Ulis, France) announced that, following discussions with the FDA, they are moving forward with their plans to file an IND for a phase I study for the transgenically derived recombinant human Factor VIIa (rhFVIIa) being developed in their joint venture. This rhFVIIa is being developed for the treatment of hemophilia patients who have developed antibodies to Factor VIII or Factor IX. GTC and LFB plan to initiate the phase I study in the second quarter of 2010.

Idera Pharmaceuticals Initiates Phase 1 Clinical Trial of IMO-3100, a Toll-like Receptor Antagonist Intended for Autoimmune Disease Indications

Thu, 28 Jan 2010

CAMBRIDGE, Mass., Jan 28, 2010 (BUSINESS WIRE) -- Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) today announced initiation of a Phase 1 clinical trial of IMO-3100, an antagonist of Toll-like Receptor (TLR) 7 and TLR9.

"As an antagonist of TLR7 and TLR9, IMO-3100 has a novel mechanism of action and presents a potentially innovative approach in the treatment of a number of autoimmune diseases," said Sudhir Agrawal, D.Phil., Chief Executive Officer and Chief Scientific Officer. "IMO-3100 is our fourth compound to advance into clinical development, each for a different therapeutic application."

GenVec Announces Registered Offering of $28 Million in Common Stock and Warrants

Wed, 27 Jan 2010

GAITHERSBURG, Md., Jan. 27 /PRNewswire-FirstCall/ -- GenVec, Inc. (Nasdaq: GNVC) announced today that it has entered into purchase agreements with certain institutional investors for the sale of 14,000,000 shares of its common stock and warrants to purchase 4,200,000 shares of its common stock. The shares of common stock and warrants are being offered in units consisting of one share of common stock and 0.30 warrants to purchase one share of common stock at a price of $2.00 per unit. The warrants have a term of five years and an exercise price of $2.75 per share.

MorphoSys Licenses HuCAL PLATINUM Antibody Library to Shionogi in Research Partnership

Wed, 27 Jan 2010

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today that Shionogi & Co., Ltd., Osaka, Japan, has elected to expand its current research license to cover the use of MorphoSys's HuCAL PLATINUM technology in drug discovery. In April 2009, MorphoSys and Shionogi entered into an agreement under which, for pre-agreed terms, Shionogi could gain access to HuCAL PLATINUM, the latest and most powerful MorphoSys antibody library, for a six-month beta test period. During this test period, Shionogi was able to compare HuCAL PLATINUM with its predecessor HuCAL GOLD^®, and found the new library to be considerably better.

BioCryst's Partner Shionogi Launches Peramivir In Japan Under The Name 'RAPIACTA'

Tue, 26 Jan 2010

BIRMINGHAM, Ala., Jan 26, 2010 /PRNewswire via COMTEX News Network/ -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that its partner, Shionogi & Co., Ltd. will launch RAPIACTA, intravenous (i.v.) peramivir anti-viral, to treat patients with influenza in Japan, on January 27, 2010. An English version of Shionogi's press release announcing this launch is available on the web at: http://www.shionogi.co.jp/ir_en/news/detail/e_100126.pdf

Cardium Provides Update on Commercial Development Plans for Generx Angiogenic Therapy for Heart Disease at 2010 Cell & Gene Therapy Forum

Tue, 26 Jan 2010

SAN DIEGO, Jan 26, 2010 /PRNewswire via COMTEX/ -- Cardium Therapeutics (NYSE Amex: CXM) reported today that its Cardium Biologics division provided an update on plans for the continuing commercial development of Generx(TM) (alferminogene tadenovec, Ad5FGF-4), a DNA-based angiogenic therapy product candidate for patients with coronary artery disease. The update was presented by Gabor M. Rubanyi, M.D., Ph.D., Cardium's Chief Scientific Officer at the annual 2010 Cell & Gene Therapy Forum in Washington, D.C. on January 25, 2010. An investor presentation that includes material from Dr. Rubanyi's presentation is now available on Cardium's website at http://phx.corporate-ir.net/phoenix.zhtml?c=77949&p=irol-presentations.

Dynavax Reports Positive Phase 1b Data for SD-101 in Chronic Hepatitis C Infection

Tue, 26 Jan 2010

In vitro Study Shows SD-101 Induces Both IFN-lambda and IFN-alpha

BERKELEY, CA, Jan 26, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today data from two studies that differentiate SD-101 from standard-of-care as well as emerging treatments for chronic HCV infection. The findings of a Phase 1b clinical trial and an in vitro study of SD-101's mechanism of action show that the second-generation TLR9 agonist (1) is well tolerated and safe and (2) induces both IFN-lambda and IFN-alpha at concentrations producing antiviral activity. The data will be presented at the 45th Annual Meeting of the European Association for the Study of the Liver in Vienna, Austria in April 2010.

Poniard Pharmaceuticals Announces Phase 2 Trial of Picoplatin in Metastatic Colorectal Cancer Meets Primary Endpoint and Study Objectives

Mon, 25 Jan 2010

SOUTH SAN FRANCISCO, Calif., Jan 24, 2010 /PRNewswire via COMTEX News Network/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on innovative oncology therapies, today announced final data from a randomized, controlled Phase 2 trial of picoplatin in metastatic colorectal cancer (CRC) patients. The study met its primary objective, as picoplatin in combination with 5-fluorouracil and leucovorin (FOLPI regimen) was associated with a statistically significant reduction in neurotoxicity (p <0.004) compared to oxaliplatin given in combination with 5-fluorouracil and leucovorin (FOLFOX regimen). Results also suggested that FOLPI had similar efficacy to FOLFOX.

StemCells, Inc. Launches First Cell Culture Medium to Enable Derivation and Maintenance of True Rat Embryonic Stem Cells

Mon, 25 Jan 2010

PALO ALTO, Calif., Jan 25, 2010 (GlobeNewswire via COMTEX) -- StemCells, Inc. (Nasdaq:STEM) announced today the launch of GS1-R(TM), the first commercially available medium to enable the derivation, maintenance and growth of true (germline competent) rat embryonic stem (ES) cells. GS1-R, the latest addition to the Company's SC Proven(R) line of specialty cell culture products, is expected to have significant utility in the creation of genetically engineered rat models of human disease for use in academic, medical and pharmaceutical research.

Data from GenVec's (GNVC) TNFerade Esophageal Cancer Study Presented at 2010 ASCO Gastrointestinal Cancer Symposium

Fri, 22 Jan 2010

GAITHERSBURG, Md., Jan. 22 /PRNewswire-FirstCall/ -- GenVec, Inc. (Nasdaq: GNVC) announced today that data from the Company's trial in esophageal cancer were presented at the American Society of Clinical Oncology's 2010 Gastrointestinal Cancer Symposium in Orlando, Florida on January 22, 2010.

The poster, titled, "Long term survival analysis of multicenter clinical trial using endoscopy (END) and endoscopic ultrasound (EUS) guided fine needle injection (FNI) of antitumor agent (TNFerade Biologic (TNF)) in patients with locally advanced esophageal cancer," reports on updated efficacy and survival data. In the 24 patients receiving TNFerade in combination with chemoradiation, the median survival was 47.7 months. Median survival from other historical clinical trials in similar stage disease ranged from 9.7 to 34 months.

Access Pharmaceuticals raises $6.3 million in registered direct offering

Fri, 22 Jan 2010

ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP), today announced that it has entered into definitive agreements with accredited investors to sell in a registered direct offering an aggregate of 2.10 million shares of its common stock at a price of$3.00 per share for aggregate gross proceeds of $6.3 million. Additionally, at the closing, Access will issue to the investors warrants to purchase, in the aggregate, approx. 1.05 million shares of common stock at a price of $3.00 per share, which warrant are exercisable immediately for a term of 5 years from the closing date. The closing of the offering is expected to take place subject to the satisfaction of customary closing conditions.

RITA NEWS: Targeted Genetics (TGEN) Removed from Rita Biotech Stock Index Following Delisting

Fri, 22 Jan 2010

Targeted Genetics (TGEN) has been removed from the Rita Biotech Stock Index as of their delisting from the Nasdaq Stock Exchange on Thursday, January 21, 2010. For more information on the company's delisting, please see the previously posted press release, here.

Sunesis Completes Enrollment of Voreloxin Phase 1b/2 Combination Trial in Acute Myeloid Leukemia

Thu, 21 Jan 2010

SOUTH SAN FRANCISCO, CA, Jan 21, 2010 (MARKETWIRE via COMTEX News Network) -- Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today reported that it has completed enrollment in its Phase 1b/2 clinical trial evaluating voreloxin, the company's lead compound, in combination with cytarabine, a widely used chemotherapy, in patients with relapsed or refractory acute myeloid leukemia (AML). A total of 110 patients with relapsed or refractory AML were enrolled in this study, including 50 primary refractory or first relapse AML patients enrolled in the expansion Phase 2 segments of the trial.

Agennix Expands Talactoferrin Phase 3 FORTIS-M Registration Trial Globally

Thu, 21 Jan 2010

Martinsried/Munich (Germany), Princeton, NJ and Houston, TX, January 21, 2010 - Agennix AG (Frankfurt Stock Exchange: AGX) today announced that the next stage of the FORTIS-M trial has begun, with the first patient being dosed in Europe. FORTIS-M is a Phase 3 registration trial evaluating oral talactoferrin versus placebo in advanced non-small cell lung cancer (NSCLC) in patients whose disease has progressed following two or more prior therapies. The trial is expected to enroll approximately 720 patients. Enrollment is ongoing at sites in the U.S. and is now being expanded into Europe and the rest of the world.

"Expansion of the FORTIS-M trial to sites outside the U.S. is an important step in the continued development of talactoferrin for non-small cell lung cancer," said Rajesh Malik, M.D., Chief Medical Officer. "Patient recruitment is on track and, assuming the trial proceeds as planned, completion of enrollment is anticipated to occur sometime in the first half of 2011, with top line data available by the end of 2011."

CytRx Announces 2010 Clinical and Development Milestones

Thu, 21 Jan 2010

LOS ANGELES, Jan 21, 2010 (BUSINESS WIRE) -- CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical company specializing in oncology, today announced its plans for 2010 aimed at advancing the clinical development of its high-value drug development pipeline and enhancing shareholder value.

"After successfully completing all of our 2009 goals, we intend to aggressively move ahead this year with multiple oncology development programs with a focus on rapid commercialization," said Steven A. Kriegsman, CytRx President and CEO. "Our oncology compounds are based on known mechanisms of action, which we believe reduces the development risk, while being clearly differentiated from currently approved treatments.

EntreMed Receives NASDAQ Staff Determination Letter Regarding Non-Compliance with Minimum Bid Price Rule and Requests Hearing

Wed, 20 Jan 2010

ROCKVILLE, MD, January 20, 2010 – EntreMed, Inc. (Nasdaq: ENMD) today announced that on January 19, 2010, it received a Staff Determination letter from the NASDAQ Stock Market (NASDAQ) stating that the Company has not regained compliance with the $1.00 minimum closing bid price requirement for continued listing under the NASDAQ Listing Rule 5450(a)(1), and that its common stock is, therefore, subject to delisting from the NASDAQ Capital Market. The letter states that, unless EntreMed requests a hearing before a NASDAQ Hearings Panel, the Company’s common stock would be subject to delisting from the NASDAQ Capital Market on January 28, 2010.

Rosetta Genomics Ltd. Closes $5.1 Million Financing; Will Support Ongoing Development of microRNA-based Diagnostic Pipeline

Wed, 20 Jan 2010

PHILADELPHIA & REHOVOT, Israel, Jan 19, 2010 (BUSINESS WIRE) -- Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer of microRNA-based molecular diagnostics, today announced that it has completed its previously announced registered direct offering with several institutional investors of approximately $5.1 million of securities. Rosetta has received net proceeds of approximately $4.5 million after deducting placement agent fees and other offering expenses. Under the terms of the financing Rosetta has sold 2,530,000 units, consisting of an aggregate of 2,530,000 ordinary shares and warrants to purchase 1,265,000 additional ordinary shares. Each unit, consisting of one ordinary share and a warrant to purchase 0.50 of an ordinary share, was sold for a purchase price of $2.00.

Targeted Genetics Corporation Receives Delisting Determination

Wed, 20 Jan 2010

SEATTLE, Jan 20, 2010 (BUSINESS WIRE) -- Targeted Genetics Corporation (NASDAQ:TGEN) (the "Company") today announced that it has received a written notice from the staff of The NASDAQ Stock Market ("NASDAQ") informing the Company that trading of the Company's common stock would be suspended prior to the open of business on Thursday, January 21, 2010, and that NASDAQ would initiate procedures to delist the Company's common stock. The Company had notified NASDAQ on January 13, 2010 of its decision not to pursue a reverse stock split as a means to regain compliance with the $1.00 share price required for continued listing under Listing Rule 5550(a)(2). The Company does not intend to appeal NASDAQ's determination.

The Institute of Cancer Research, Sareum and Cancer Research Technology Limited

Wed, 20 Jan 2010

New Molecules Increase the Effectiveness of Certain Cancer Therapies

Scientists at The Institute of Cancer Research (“ICR”) and Sareum have developed novel chemical compounds that increase the effectiveness of current cancer therapeutics, an example of which is published in the latest edition of the journal Molecular Cancer Therapeutics*.

Cleveland BioLabs Doses First Volunteers in Second Safety Study for CBLB502

Tue, 19 Jan 2010

BUFFALO, NY, Jan 19, 2010 (MARKETWIRE via COMTEX) -- Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that the first healthy volunteers have been dosed in the second human safety study for CBLB502, a drug under development for the treatment of Acute Radiation Syndrome (ARS).

CBLB502 is being developed by Cleveland BioLabs under the U.S. Food and Drug Administration's Animal Efficacy Rule to treat Acute Radiation Syndrome (ARS) or radiation poisoning from any exposure to radiation such as a nuclear or radiological weapon / dirty bomb, or from a nuclear accident. This approval pathway requires demonstration of efficacy in representative animal models and safety and pharmacodynamic drug marker testing in healthy human volunteers.

RXi Pharmaceuticals Presented New Pre-Clinical Data at the Keystone RNAi Silencing Conference

Tue, 19 Jan 2010

WORCESTER, Mass., Jan 19, 2010 (BUSINESS WIRE) -- RXi Pharmaceuticals Corporation (Nasdaq: RXII), a biopharmaceutical company pursuing the development and commercialization of proprietary therapeutics based on RNA interference (RNAi), today announced that new pre-clinical data using proprietary rxRNA(TM) compounds was presented at the Keystone Symposia's RNA Silencing: Mechanism, Biology and Application held January 14-19 in Keystone, Colorado.

GenVec Enters Collaboration on Hearing Loss Treatments With Leading Global Pharmaceutical Company

Tue, 19 Jan 2010

GAITHERSBURG, Md., Jan. 19 /PRNewswire-FirstCall/ -- GenVec, Inc. (Nasdaq: GNVC) today announced that the company has entered into a research collaboration and license agreement.

GenVec and Novartis will collaborate to discover and develop novel treatments for hearing loss and balance disorders. Preclinical results suggest that delivery of the atonal gene using GenVec's innovative adenovector technology may have the potential to restore hearing and balance function.

Idera Pharmaceuticals Announces Achievement of Clinical Milestone Under Its Collaboration with Merck KGaA for Cancer Treatment

Tue, 19 Jan 2010

CAMBRIDGE, Mass., Jan 19, 2010 (BUSINESS WIRE) -- Idera Pharmaceuticals, Inc. (Nasdaq: IDRA), today announced that it has achieved a milestone under its worldwide licensing and collaboration agreement with Merck KGaA, Darmstadt, Germany. The milestone was achieved upon initiation of a Phase 2 trial by Merck KGaA of EMD 1201081, a novel agonist of Toll-like Receptor 9 (TLR9), in combination with cetuximab (Erbitux(R)) in second-line cetuximab-naïve patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Under the terms of the agreement, the Company is entitled to receive a payment of EUR 3.0 million (approximately $4.3 million) from Merck KGaA.

CytRx to Conduct Phase 2 Clinical Trial with Bafetinib in B-cell Chronic Lymphocytic Leukemia

Fri, 15 Jan 2010

LOS ANGELES, Jan 13, 2010 (BUSINESS WIRE) -- CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical company specializing in oncology, today announced plans to initiate a Phase 2 proof-of-concept clinical trial to evaluate the efficacy and safety of bafetinib (formerly known as INNO-406) in patients with high-risk B-cell chronic lymphocytic leukemia (B-CLL).

Key Event Occurs in GenVec's PACT Trial

Fri, 15 Jan 2010

GAITHERSBURG, Md., Jan. 15 /PRNewswire-FirstCall/ -- GenVec, Inc. (Nasdaq: GNVC) announced today that 184 events (deaths) have occurred in its ongoing Phase III Pancreatic Cancer Clinical Trial with TNFerade™ (PACT) in patients with locally advanced pancreatic cancer. This event, which represents two-thirds of the total events expected in the trial, triggers the next interim analysis of overall survival in the trial. GenVec expects data from this interim analysis to be available in approximately 10-12 weeks.

BioCryst's CTCL Pivotal Study Achieves Enrollment Target

Fri, 15 Jan 2010

BIRMINGHAM, Ala., Jan 15, 2010 /PRNewswire via COMTEX News Network/ -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that it has achieved its protocol-specified objective of enrolling 100 late-stage patients (Stage IIB to IVA) in its pivotal study for forodesine in the treatment of cutaneous T-cell lymphoma (CTCL). Top-line data is expected in the second half of 2010. Additionally, BioCryst's exploratory Phase 2 study for forodesine in subjects with chronic lymphocytic leukemia (CLL) is continuing to progress and has enrolled over half of its targeted number of patients.

Rosetta Genomics Ltd. to Raise $5.1 Million in Registered Direct Offering

Thu, 14 Jan 2010

PHILADELPHIA & REHOVOT, Israel, Jan 13, 2010 (BUSINESS WIRE) -- Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer of microRNA-based molecular diagnostics, today announced that it has received commitments from certain institutional investors to purchase approximately $5.1 million of securities in a registered direct offering. Rosetta expects to receive net proceeds of approximately $4.5 million after deducting placement agent fees and other offering expenses. Rosetta has entered into securities purchase agreements with these investors pursuant to which Rosetta has agreed to sell an aggregate of 2,530,000 shares of its ordinary shares and warrants to purchase up to 1,265,000 additional ordinary shares. Each unit, consisting of one ordinary share and a warrant to purchase 0.50 of an ordinary share, will be sold for a purchase price of $2.00.

Dyax Launches HAE Hope, A New Online Resource for Patients with Hereditary Angioedema

Thu, 14 Jan 2010

Website Offers Tools for Recognizing Attack Triggers and Managing the Disease

CAMBRIDGE, Mass., Jan 14, 2010 (BUSINESS WIRE) -- A new, online resource is now available for patients with hereditary angioedema (HAE), their caregivers and physicians. The website, www.HAEHope.com, launched today by Dyax Corp. (NASDAQ: DYAX), offers resources to help patients and their families better understand and manage HAE, a rare, genetic disease characterized by episodes of severe and painful swelling.

Sunesis Announces Publication of Nonclinical Voreloxin Data in Leukemias

Thu, 14 Jan 2010

Studies Demonstrate Voreloxin Acts Synergistically With Cytarabine and Induces Bone Marrow Aplasia

SOUTH SAN FRANCISCO, CA, Jan 14, 2010 (MARKETWIRE via COMTEX News Network) -- Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today announced the publication of new nonclinical studies with the Company's lead drug candidate, voreloxin, in the journal Cancer Chemotherapy and Pharmacology. The results demonstrate voreloxin's potent cytotoxic activity in human acute leukemia cell lines and in an in vivo model when used alone, and enhanced or synergistic activity when used in combination with cytarabine. Sunesis is currently completing Phase 2 studies of voreloxin as a single-agent or in combination with cytarabine in acute myeloid leukemia (AML) and expects to begin Phase 3 testing in AML later in 2010.

RXi Pharmaceuticals and the University of Massachusetts Medical School Announce Research Collaboration Focused on Ocular Disease

Thu, 14 Jan 2010

WORCESTER, Mass., Jan 14, 2010 (BUSINESS WIRE) -- RXi Pharmaceuticals Corporation (Nasdaq: RXII), a biopharmaceutical company pursuing the development and commercialization of proprietary therapeutics based on RNA interference (RNAi), today announced a collaboration with Shalesh Kaushal, M.D., Ph.D., Chairman of the Department of Ophthalmology at The University of Massachusetts Medical School (UMMS). The research collaboration will be focused on the application of RXi's self-delivering RNAi (sd-rxRNA(TM)) compounds for ocular diseases such as age-related macular degeneration, the leading cause of blindness in Americans over 55 years of age.

Rosetta Announces that Johns Hopkins University Researchers Demonstrate miRview™ squamous Classifies Non-Small Cell Lung Cancer with Extremely High Degree of Accuracy

Wed, 13 Jan 2010

The studyi published online in Clinical Cancer Research, shows 100% concordance in classifying non small cell lung cancer (NSCLC) between results obtained using miRview(TM) squamous and results obtained using diagnostics that exceed current methods Routine histopathology (H&E staining) is the current "gold standard" method of lung cancer classification, but this method is considered unreliableii iii iv, with poor reproducibility, and low inter- and intra-observer correlation miRview(TM) squamous correctly classified 95% of fine-needle aspirate specimens originally diagnosed as poorly differentiated NSCLC, into squamous or non squamous, suggesting potential applications in preoperative settings

BioCryst's Partner Shionogi Receives Marketing & Manufacturing Approval For Peramivir in Japan

Wed, 13 Jan 2010

BIRMINGHAM, Ala., Jan 13, 2010 /PRNewswire via COMTEX News Network/ -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that its partner, Shionogi & Co., Ltd. has received marketing and manufacturing approval for intravenous (i.v.) peramivir to treat patients with influenza in Japan. Shionogi intends to commercially launch peramivir under the commercial name RAPIACTA in Japan, pending the product's National Health Insurance (NHI) price listing.

As a result of this approval, BioCryst will receive a third and final regulatory milestone payment of $7 million under its license agreement with Shionogi. BioCryst may receive future commercial event milestone payments of up to $95 million from Shionogi.

Targeted Genetics Announces Decision to Delist and Deregister Its Common Stock

Wed, 13 Jan 2010

SEATTLE, Jan 13, 2010 (BUSINESS WIRE) -- Targeted Genetics Corporation (NASDAQ:TGEN) (the "Company") today announced that it has determined that the expense and management attention required for NASDAQ Capital Market and Securities and Exchange Commission ("SEC") compliance outweigh the benefits for the Company and its shareholders at this time. The Company believes that its limited resources may be more productively utilized to support continued efforts to monetize certain assets, to realize value from milestone and royalty licensing relationships, and to support product development programs currently underway with commercial and academic partners.

Dynavax Expands Commercial and Clinical Leadership

Tue, 12 Jan 2010

BERKELEY, CA, Jan 12, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today the addition of two new senior executives to direct key commercial and clinical activities prior to the launch of HEPLISAV(TM), an investigational adult hepatitis B vaccine.

Brant Biehn, after more than 20 years with Merck, joins as Chief Commercial Development Officer. Mr. Biehn will be responsible for the development and execution of Dynavax's commercial strategy, including market development, sales, and distribution channel partnerships.

EntreMed Completes Registered Direct Offering of $2.5 Million in Common Stock

Tue, 12 Jan 2010

ROCKVILLE, MD, January 12, 2010 – EntreMed, Inc. (Nasdaq: ENMD) today announced that, on January 11, 2010, it completed a registered direct offering of 3,125,000 shares of its common stock, at a purchase price of $0.80 per share, to a single accredited institutional investor. The sale resulted in gross proceeds to the Company of $2.5 million. The terms of the purchase were set forth in a stock purchase agreement entered into by the parties on January 8, 2010. The per share purchase price reflects a 7% discount to the ten-day average closing sale price ending on January 7, 2010.

BioCryst and moksha8 Announce Approval for the Importation & Use of peramivir in Mexico

Tue, 12 Jan 2010

BIRMINGHAM, Ala., Jan 12, 2010 /PRNewswire via COMTEX News Network/ -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that moksha8 has been granted approval from COFEPRIS (The Federal Commission for the Protection against Sanitary Risk) in Mexico for the importation and use of peramivir in patients with influenza associated with the 2009 H1N1 influenza A strain. moksha8 has informed BioCryst that it has also filed for regulatory approval of peramivir in Brazil. Peramivir is the only intravenous (i.v.) anti-viral that is currently available under an Emergency Use Authorization (EUA) in the U.S. in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza A infection who are admitted to a hospital.

Ablynx Successfully Generates Nanobodies Against an Ion Channel and Announces New GPCR Program

Mon, 11 Jan 2010

GHENT, Belgium, 11 January 2010 - Ablynx [Euronext Brussels: ABLX] announced today two significant advances achieved within its R&D portfolio. In the first, it has demonstrated the successful generation of functional Nanobodies against an ion channel. In the second, Ablynx has demonstrated in vivo proof-of-concept for a GPCR targeting stem cell mobilization programme. The target, CXCR4, is a validated chemokine receptor that plays an important role in cell movement, tumor growth and metastasis.

Peregrine Pharmaceuticals Appoints Dr. Marvin R. Garovoy as Head of Clinical Science

Mon, 11 Jan 2010

Focus Will Be on Establishing Investigator-Sponsored Trials Program to Expand Bavituximab Clinical Development Efforts - - Brings Extensive Experience in the Design and Conduct of Clinical Trials for Innovative Therapies for Cancer and Other Indications

TUSTIN, Calif., Jan 11, 2010 /PRNewswire via COMTEX News Network/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq:PPHM) today announced that Marvin R. Garovoy, MD, has joined the company as head of clinical science. Dr. Garovoy has extensive biotechnology industry experience in the design and conduct of clinical trials for innovative new drugs. At Peregrine, he will have primary responsibility for establishing and supervising an Investigator-Sponsored Trials (IST) program, as well as expanding scientific outreach and assisting with clinical trial design for the bavituximab and Cotara(R) programs. Dr. Garovoy brings extensive experience in the design and conduct of clinical trials and played a major role in the successful clinical development, regulatory approval and commercial launch of Raptiva(R), a monoclonal antibody drug for the treatment of psoriasis jointly developed by XOMA and Genentech.

Raptor Pharmaceutical Corp. Announces Publication of Results from Phase 2a Trial of DR Cysteamine for Treatment of Cystinosis

Mon, 11 Jan 2010

Potential to Improve Treatment with Less Frequent Administration and Better Tolerability

NOVATO, Calif., Jan 11, 2010 /PRNewswire via COMTEX/ -- Raptor Pharmaceutical Corp. ("Raptor" or the "Company") (Nasdaq: RPTP), today announced the publication of results from a Phase 2a clinical trial of a prototype formulation of its proprietary delayed-release cysteamine bitartrate ("DR Cysteamine") in patients with nephropathic cystinosis ("cystinosis"). Ranjan Dohil, M.D., Professor of Pediatrics at the University of California, San Diego, was lead author of the study to be published in the Journal of Pediatrics and available online at http://www.ncbi.nlm.nih.gov/pubmed/19775699?itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum&ordinalpos=1.

Pluristem Therapeutics Announces Interim Results from PLX-PAD Clinical Trials

Mon, 11 Jan 2010

HAIFA, ISRAEL, Jan. 11, 2010--Pluristem Therapeutics Inc. (NasdaqCM: PSTI; DAX: PJT) today announced interim results from their Phase I clinical trials utilizing their placenta derived cell therapy product, PLX-PAD, for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD). Data suggested that PLX-PAD is safe and potentially efficacious.

BioCryst Announces Two Additional Peramivir Partnerships

Mon, 11 Jan 2010

BIRMINGHAM, Ala., Jan 11, 2010 /PRNewswire via COMTEX News Network/ -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that it has signed agreements with two additional partners who will exclusively represent BioCryst and its anti-viral peramivir for influenza stockpiling opportunities for territories outside of the U.S. BioCryst's new partners are Merck Serono for Europe, Russia, Canada and Singapore and Hikma Pharmaceuticals PLC for the Middle East and North Africa (MENA) region, excluding Israel. BioCryst and its seven regional partners for peramivir cover all major and the majority of smaller pharmaceutical markets globally.

BioTime Subsidiary OncoCyte Corporation Receives Second $2,000,000 Equity Tranche; BioTime Plans Additional $2,250,000 Investment

Fri, 8 Jan 2010

BioTime, Inc. (NYSE Amex:BTIM) announced that its subsidiary OncoCyte Corporation has completed the funding of the second tranche of a private equity offering through the sale of 3,000,000 shares of OncoCyte common stock for $2,000,000 to a private investor. BioTime plans to invest an additional $2,250,000 of its own cash in OncoCyte during the first quarter of 2010. OncoCyte plans to use these funds to accelerate its research efforts and to further develop its management team, staff, and business.

BioCryst's Partner Green Cross Files for Peramivir Regulatory Approval in South Korea

Fri, 8 Jan 2010

BIRMINGHAM, Ala., Jan 08, 2010 /PRNewswire via COMTEX News Network/ -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that it has been informed by its partner, Green Cross Corp., that Green Cross has filed a New Drug Application (NDA) in South Korea to seek regulatory approval for intravenous (i.v.) peramivir to treat patients with influenza.

BioMimetic Therapeutics Strengthens its Agreement with Novartis for Exclusive Supply of rhPDGF-BB

Thu, 7 Jan 2010

FRANKLIN, Tenn.--(BUSINESS WIRE)--BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today announced that effective December 31, 2009, the Company amended and restated its manufacturing and supply agreement with Novartis Vaccines and Diagnostics, Inc. for the supply of bulk rhPDGF-BB to BioMimetic. The agreement sets forth a clear and strengthened mutual exclusivity commitment whereby Novartis shall manufacture rhPDGF-BB exclusively for BioMimetic for therapeutic applications covering bone, cartilage, tendon and ligaments.

GenVec Regains Compliance with NASDAQ Listing Requirements

Thu, 7 Jan 2010

GAITHERSBURG, Md., Jan. 7 /PRNewswire-FirstCall/ -- Today GenVec, Inc. (Nasdaq: GNVC) announced that on January 7, 2010, the Company received a letter from The NASDAQ Stock Market advising that it had regained compliance with the NASDAQ's minimum bid price listing requirements.

Poniard Pharmaceuticals Announces 2010 Goals for Picoplatin

Thu, 7 Jan 2010

SOUTH SAN FRANCISCO, Calif., Jan 07, 2010 /PRNewswire via COMTEX News Network/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD) today provided an overview of its 2010 corporate, clinical and regulatory goals for picoplatin.

"Our focus in 2010 is to secure a strategic partnership to continue the development of picoplatin as a preferred platinum agent in the treatment of solid tumor malignancies. We believe that current data from approximately 1,100 patients treated with picoplatin, including data from Phase 2 trials of picoplatin in colorectal, prostate and ovarian cancers, indicate that picoplatin would be a valuable addition to potential partners with marketed and development stage oncology products," said Jerry McMahon, Ph.D., chairman and chief executive officer of Poniard. "Throughout the first half of this year, we plan to a have discussions with the U.S. Food and Drug Administration regarding a regulatory path forward for picoplatin in small cell lung cancer. We expect to submit efficacy and safety data from the Phase 3 SPEAR trial for potential presentation at the American Society of Clinical Oncology 2010 Annual Meeting in June."

Access Pharmaceuticals announces completion of ProLindac monotherapy trial and initiation of combination study

Thu, 7 Jan 2010

DALLAS, TX, January 7 2009 - ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), today announced that it has completed enrollment and evaluation of the last additional cohort of patients in the ongoing clinical study of ProLindac as a monotherapy in ovarian cancer patients who have received at least two prior platinum based treatment regimens. The additional cohort of 8 patients received the ProLindac batch made by an improved scalable process, which will be used on a larger scale for future clinical and commercial supplies. None of the 8 patients experienced any acute significant adverse events, while treatment had the same beneficial pharmacodynamic effect seen in the first 26 patients treated with the former ProLindac production batch; clinically relevant sustained biomarker decrease (responses by Rustin’s criteria) and disease stabilization were seen in several patients. The overall results of our Phase I/II exploratory single agent ProLindac study have helped define multiple safe dosing regimens, while the level of patient cohort accrued in the study antitumor activity was as expected in this very heavily pretreated patient cohort.

BioMimetic Therapeutics Strengthens its Agreement with Novartis for Exclusive Supply of rhPDGF-BB

Wed, 6 Jan 2010

FRANKLIN, Tenn., Jan 06, 2010 (BUSINESS WIRE) -- BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today announced that effective December 31, 2009, the Company amended and restated its manufacturing and supply agreement with Novartis Vaccines and Diagnostics, Inc. for the supply of bulk rhPDGF-BB to BioMimetic. The agreement sets forth a clear and strengthened mutual exclusivity commitment whereby Novartis shall manufacture rhPDGF-BB exclusively for BioMimetic for therapeutic applications covering bone, cartilage, tendon and ligaments.

OncoMethylome Sciences to Perform MGMT Testing in Roche Phase III Study of Avastin for Glioblastoma

Wed, 6 Jan 2010

OncoMethylome's Technology is being used in Roche Clinical Trial Program with Avastin

Liege (Belgium) - January 6, 2010, 8:00 AM CET - OncoMethylome Sciences (Euronext Brussels: ONCOB, Euronext Amsterdam: ONCOA) announced today that it has entered into an agreement with F. Hoffmann-La Roche Ltd., of Basel Switzerland, for MGMT gene promoter methylation testing in a Phase III clinical trial for the use of Avastin in newly diagnosed (glioblastoma [GBM]) brain tumors.

Cleveland BioLabs Receives First U.S. Patent for Radiation Protection Drug CBLB502

Wed, 6 Jan 2010

BUFFALO, NY, Jan 06, 2010 (MARKETWIRE via COMTEX) -- Cleveland BioLabs, Inc. (NASDAQ: CBLI) announced today that the U.S. Patent and Trademark Office has issued US Patent No. 7,638,485 titled "Modulating Apoptosis" covering the method of protecting a mammal from radiation using flagellin or its derivatives, including CBLB502. This patent was already granted by the nine member countries of the Eurasian Patent Organization (EAPO), and two additional nations.

NeoPharm Presents the Phase II Data of Liposome-Entrapped Paclitaxel (LEP) in Patients with Metastatic Breast Cancer

Wed, 6 Jan 2010

LAKE BLUFF, Ill., Jan 06, 2010 (BUSINESS WIRE) -- NeoPharm, Inc. (Other OTC: NEOL.PK) today announced the results of a Phase II clinical trial of Liposome-Entrapped Paclitaxel (LEP) an active component of Taxol(R). This multicenter, open-label trial of LEP was conducted at 5 centers in India.

Thirty-five subjects were enrolled and received LEP doses of 275 mg/m² administered over 90 minutes every 21 days without routine prophylactic pre-medication for infusion-related reactions. Subjects received a median of 6 cycles (range 2 to 10) with 22 subjects receiving greater-than or equal to 6 cycles. Overall tumor responses with fully audited data were as follows: 16 subjects (46%) with tumor response including 15 partial responses and one complete response; 10 subjects (29%) with stable disease (mean duration, 6 cycles; range, 2-10 cycles); 9 subjects (25%) with progressive disease. LEP was well tolerated with sensory polyneuropathy greater-than or equal to grade 3 in only one subject (3%) and neutropenia greater-than or equal to grade 3 in 2 subjects (6%), two common toxicities of Taxol(R) and Abraxane(R). No significant infusion-related reactions were observed as indicated by adverse events or prophylactic pre-medication use.

CytRx Announces Plan to Initiate a Phase 2 Clinical Trial with INNO-206 as a Treatment for Advanced Pancreatic Cancer

Wed, 6 Jan 2010

Previously Announced Animal Trial with INNO-206 Showed a Statistically Significant Three-Fold Reduction in Pancreatic Tumor Size, Outperforming the Current Standard of Care

LOS ANGELES, Jan 06, 2010 (BUSINESS WIRE) -- CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical company, today announced that the Tumor Biology Center, Freiburg, Germany, plans to initiate a Phase 2 clinical trial with CytRx's doxorubicin prodrug INNO-206 as a treatment for patients with advanced pancreatic cancer. CytRx, which holds the exclusive worldwide rights to INNO-206, will supply INNO-206 for the clinical trial. CytRx previously announced plans to initiate Phase 2 clinical trials with INNO-206 in patients with advanced soft tissue sarcomas and advanced gastric cancer.

Cardium to Launch MedPodium Product Line Initially Covering Six New Advanced Foot Care Products for Podiatry Patients to Complement the Excellagen Platform

Tue, 5 Jan 2010

SAN DIEGO, Jan 05, 2010 /PRNewswire-FirstCall via COMTEX/ -- Cardium Therapeutics (NYSE Amex: CXM) today announced plans to launch a new premium advanced skin care product line to promote foot health and comfort for podiatry patients. Cardium's new MedPodium(TM) product line is an over-the-counter product portfolio for patients with the potential for foot disorders and ailments. MedPodium represents a new line of foot care products to broaden and complement Cardium's Excellagen topical gel product candidate platform, which is currently subject to a pending FDA 510(k) application submission for U.S. marketing clearance, for the management of wounds including partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, surgical wounds and certain other wounds.

Cardium Reports on Non Compliance With NYSE AMEX

Tue, 5 Jan 2010

SAN DIEGO, Jan 04, 2010 /PRNewswire-FirstCall via COMTEX/ -- Cardium Therapeutics (NYSE Amex: CXM) reported that it received notification from the staff of the company's current listing exchange indicating that the company is currently considered to be noncompliant with certain listing requirements of the NYSE AMEX LLC. Based on the company's quarterly report on Form 10-Q, which was filed on November 9, 2009, noncompliance was noted with respect to the requirements for minimum stockholders' equity under section 1003(a)(i) of the exchange's company guide with stockholders' equity of less than $2,000,000 and losses from continuing operations and net losses in two of its three most recent fiscal years and section 1003(a)(ii) of the exchange's company guide with stockholders' equity of less than $4,000,000 and losses from continuing operations and net losses in three of its four most recent fiscal years.

RITA NEWS: Rita Biotech Updates the Biotech Stock Index for the New Year

Mon, 4 Jan 2010

For the new year Rita Biotech has updated the Biotech Stock Index to reflect the spirit of the index, which is to be comprised of active but small early-stage biotechnology companies with little to no revenue.

Please visit the Biotech Stock Index here to see the updated list of companies.

Dynavax Completes Symphony Dynamo Acquisition

Mon, 4 Jan 2010

$20 Million Cash Proceeds to Support HEPLISAV Registration Trials

Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that stockholders approved the acquisition of Symphony Dynamo, Inc. (SDI), including approximately $20 million in cash and all rights to Dynavax's hepatitis C and cancer therapy programs.

Dynavax expects the proceeds from this transaction to contribute significantly toward the completion of its registration trials for HEPLISAV(TM), the Company's investigational adult hepatitis B vaccine.

Compugen Discovers Drug Target for Treatment of Epithelial Tumors

Mon, 28 Dec 2009

Tel Aviv, Israel, December 28, 2009 --- Compugen Ltd. (NASDAQ: CGEN) announced today the discovery and experimental validation of CGEN-671, a new drug target for multiple epithelial tumors. CGEN-671 is a membrane splice variant of CD55, a known drug target for gastric cancer for which monoclonal antibody (mAb) therapeutics are in clinical development by others. The potential application of CGEN-671 as a drug target was initially predicted in silico by Compugen through the use of its Monoclonal Antibody Targets Discovery Platform; the predicted molecule was then validated experimentally in multiple epithelial tumors. Epithelial tumors, also referred to as carcinomas, account for approximately 85% of all cancers, including the ten most prevalent cancers in the western world, such as breast, colorectal, lung, ovary, prostate and skin. Compugen has filed patent applications covering this novel splice variant and its various therapeutic and diagnostic utilities.

Raptor Pharmaceutical Corp. Announces Closing of $7.5 Million Registered Direct Offering

Mon, 28 Dec 2009

NOVATO, Calif., Dec 23, 2009 /PRNewswire-FirstCall via COMTEX/ -- Raptor Pharmaceutical Corp. ("Raptor" or the "Company") (Nasdaq: RPTP), today announced that on December 22, 2009, it completed its registered direct offering with institutional investors, raising an aggregate amount of approximately $7.5 million of gross proceeds (before placement agent fees and offering expenses) through the sale of 3,747,558 units. The units consist of one share of common stock and one warrant to purchase 0.5 of a share of common stock with a term of five years, and one warrant to purchase 0.5 of a share of common stock with a term of 18 months. Both warrants have an exercise price of $2.45 per share of common stock and are not exercisable for six months. The shares of common stock and warrants were issued separately.

Rigel Receives Milestone Payment from Daiichi Sankyo for Cancer Ligase Target

Wed, 23 Dec 2009

SOUTH SAN FRANCISCO, Calif., Dec 23, 2009 /PRNewswire-FirstCall via COMTEX/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that it has received a milestone payment from Daiichi Sankyo Co., Ltd. as part of their collaboration to research and develop cancer treatments aimed at selectively inhibiting ligases, which are intrinsic to cancer cell growth and proliferation. The compound, as yet unnamed, targets cell division.

Cleveland BioLabs President and CEO Reports Progress on Clinical and Corporate Developments

Tue, 22 Dec 2009

BUFFALO, NY, Dec 22, 2009 (MARKETWIRE via COMTEX) -- Cleveland BioLabs, Inc. (NASDAQ: CBLI) today issued a statement from its President and CEO, Michael Fonstein, Ph.D., providing an update on clinical and corporate developments of the past year. The statement is included in its entirety below:

"As we close 2009, I would like to take this opportunity to reflect upon some of our accomplishments and update you on our overall progress. We have made great strides in the development of our most advanced compound, CBLB502 for Acute Radiation Syndrome (ARS), secured significant additional government funding, received our first US patent, and advanced commercial partnerships for two of our programs.

Systemic Treatment with AVI-4658 Demonstrates RNA Exon Skipping and Dystrophin Protein Expression in Duchenne Muscular Dystrophy Patients

Tue, 22 Dec 2009

Positive RNA and Protein Signals in First Cohorts Analyzed; Conference Call Scheduled Today at 8:30 AM Eastern Time

BOTHELL, WA — December 22, 2009 — AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based drugs, today announced initial efficacy data from the ongoing Phase 1b/2 clinical trial of AVI-4658 for the systemic treatment of patients with Duchenne muscular dystrophy (DMD), a genetic muscle wasting disease caused by failure to produce dystrophin. Patients in the first four (of six) cohorts completing 12 weeks of treatment with different doses of AVI-4658 (0.5, 1.0, 2.0 or 4.0 mg/kg) have had their muscles biopsied. Analysis of the post treatment biopsies found that patients in the 2 and 4 mg/kg drug-treatment cohorts (3 of 3 in total) showed correctly spliced mRNA for dystrophin. One of these patients, in the 2mg/kg cohort, showed robust expression of dystrophin protein by western blot and immunofluorescent analysis. No RNA or protein expression signal was detected in patients from the 0.5 mg/kg or 1.0 mg/kg cohorts after completing treatment. Restoration of functional dystrophin expression is considered critical for successful treatment of DMD.

Seattle Genetics Announces Antibody-Drug Conjugate Collaboration with GlaxoSmithKline

Mon, 21 Dec 2009

Seattle Genetics to Receive $12 Million Upfront Payment, up to $390 Million in Potential Milestone Payments and Mid-Single Digit Royalties

BOTHELL, Wash., Dec 21, 2009 (BUSINESS WIRE) -- Seattle Genetics, Inc. (NASDAQ:SGEN), announced today that it has entered into a collaboration agreement with GlaxoSmithKline (GSK) under which GSK will pay an upfront fee of $12 million for rights to utilize Seattle Genetics' antibody-drug conjugate (ADC) technology with multiple antigens to be named by GSK.

Idera Pharmaceuticals Announces Positive Interim Data from Phase 1 Clinical Trial of IMO-2125 in Chronic Hepatitis C Patients

Mon, 21 Dec 2009

CAMBRIDGE, Mass., Dec 21, 2009 (BUSINESS WIRE) -- Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) today announced positive interim results from a Phase 1 clinical trial of IMO-2125 in patients with chronic hepatitis C virus infection (HCV). IMO-2125 is an agonist of Toll-like Receptor 9 that Idera designed to treat HCV by inducing endogenous interferon-alpha and other Th1-type cytokines and chemokines.

In this four-week trial, IMO-2125 was well tolerated and induced dose-dependent increases in endogenous interferon-alpha and other cytokines. IMO-2125 also demonstrated a treatment-related decrease in viral load at escalating dose levels. All patients enrolled in the trial are null responders, which is defined as patients who have failed to achieve a 2 log10 reduction in viral load during previous 12 to 24 weeks of treatment with pegylated recombinant interferon-alpha plus ribavirin, the current standard of care treatment.

Neurocrine Advances VMAT2 Inhibitor Program

Mon, 21 Dec 2009

Phase 1 Single Ascending Dose Study Delivers Desired Pharmacokinetic Profile

SAN DIEGO, Dec 21, 2009 /PRNewswire-FirstCall via COMTEX/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced their highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor, NBI-98854, will be advanced in clinical development.

The first trial in human subjects, NBI-98854-0801, was a single ascending dose trial in healthy male volunteers conducted in Canada under an approved Clinical Trial Application (CTA) with Health Canada. Preliminary data have now been reviewed; NBI-98854 was generally safe and well tolerated. There were no Serious Adverse Events, clinically significant drug-related laboratory abnormalities or clinically significant ECG findings. More critically, the characteristics of the compound met the pre-specified pharmacokinetic requirements: dose proportionality, low maximum concentration (Cmax) with adequate area-under-curve (AUC) for drug exposure, low variability, and a half-life which supports once per day dosing.

CombiMatrix Announces Hearing Date Regarding its $36 Million Judgment Against National Union

Mon, 21 Dec 2009

MUKILTEO, Wash., Dec 21, 2009 (GlobeNewswire via COMTEX News Network) -- CombiMatrix Corporation (Nasdaq:CBMX) today announced that the U.S. 9th Circuit Court of Appeals (the "Court") has set a date for appellate oral argument in its litigation with National Union Fire Insurance Company of Pittsburgh, PA, an AIG company (NYSE:AIG). This argument is a short session (each side will have 15 minutes) to present arguments supplementing those in the Briefs that were filed with the Court earlier this year. The date and time set by the Court is Tuesday, February 2, 2010, at 9:30 a.m. The hearing will be at the Ninth Circuit Court of Appeals in Pasadena, California.

MediciNova and Avigen Stockholders Approve Merger

Fri, 18 Dec 2009

SAN DIEGO and ALAMEDA, Calif., Dec 17, 2009 (GlobeNewswire via COMTEX) -- MediciNova, Inc., a biopharmaceutical company that is publicly traded on the Nasdaq Global Market (Nasdaq:MNOV) and the Hercules Market of the Osaka Securities Exchange (Code Number:4875) and Avigen, Inc. (Nasdaq:AVGN), a biopharmaceutical company, today announced that their respective stockholders have approved the merger pursuant to which a wholly-owned subsidiary of MediciNova will merge with and into Avigen.

Transgenomic, Inc. Executes License Option agreement for Parkinson's Disease Diagnostic Markers with Gene Solutions, LLC

Fri, 18 Dec 2009

Low-level Mitochondrial DNA Variants are Linked to Disease

OMAHA, Neb., Dec. 17 /PRNewswire-FirstCall/ -- Transgenomic, Inc. (OTC Bulletin Board: TBIO) announced today that it has reached agreement with Gene Solutions for an exclusive licensing option to a set of validated mutations found in Parkinson's disease patients that can form the basis of a novel and accurate diagnostic test for Parkinson's disease. Transgenomic's platform mitochondrial mutation detection technology will be evaluated and optimized to develop a diagnostic test that evaluates and quantitates the presence of low-level mitochondrial DNA (mtDNA) variants. These mutations have been demonstrated to be present in Parkinson's disease patients but rarely in age-matched control individuals.

ARIAD Announces Full Enrollment in Phase 3 Succeed Trial Evaluating Ridaforolimus in Patients with Metastatic Sarcomas

Thu, 17 Dec 2009

CAMBRIDGE, Mass., Dec 17, 2009 (BUSINESS WIRE) -- ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced the completion of patient enrollment in its pivotal, Phase 3 clinical trial of oral ridaforolimus, its investigational mTOR inhibitor, in patients with metastatic soft-tissue and bone sarcomas. The Company believes that this international study is the largest clinical trial to be conducted in patients with sarcomas. It was initiated in September, 2007 and took just over two years to fully accrue.

Neurocrine Announces Sale of 4,784,689 Shares of Common Stock, to Raise Proceeds of $10 Million

Thu, 17 Dec 2009

SAN DIEGO, Dec 17, 2009 /PRNewswire-FirstCall via COMTEX/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today reported that it has entered into a privately negotiated transaction to sell an aggregate of 4,784,689 primary shares of its common stock to affiliates of Venrock at a price of $2.09 per share, raising aggregate gross proceeds to Neurocrine of approximately $10 million. Neurocrine expects the financing to close on or about December 22, 2009, subject to customary closing conditions.

Opexa Therapeutics, Inc. Announces Closing of $5.1 Million Registered Direct Offering

Thu, 17 Dec 2009

THE WOODLANDS, Texas--(BUSINESS WIRE)--Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company developing Tovaxin®, a novel T-cell therapy for multiple sclerosis (MS), today announced that it has completed its registered direct offering with several institutional investors to sell 2,550,000 units, each unit consisting of one share of Opexa common stock, a five-year Series A warrant to purchase 0.35 of an additional share of Opexa common stock, and a one-year Series B warrant to purchase 0.15 of an additional share of Opexa common stock.

Cardium Reports on Recent Norwegian Study Revealing That History of Foot Ulcers Is a Significant Predictor of Mortality in Diabetic Patients

Wed, 16 Dec 2009

SAN DIEGO, Dec 16, 2009 /PRNewswire-FirstCall via COMTEX/ -- Cardium Therapeutics (NYSE Amex: CXM) today reported on recent clinical findings published in the December issue of Diabetes Care showing an increase in mortality in diabetic patients with a history of foot ulcer (HFU) compared with diabetic patients without HFU and with non-diabetic patients.

Antisoma's AS1411 Shows Activity in Kidney Cancer, but AML Remains Priority

Wed, 16 Dec 2009

London, UK, and Cambridge, MA: 16 December 2009 - Antisoma plc (LSE: ASM; USOTC: ATSMY) announces that results of its phase II trial of AS1411 as a second-line treatment for metastatic renal cell carcinoma (RCC; kidney cancer) provide further evidence that the drug has anti-cancer activity. Safety findings suggest that AS1411 is exceptionally well tolerated compared to most current cancer treatments. Data from the trial will be submitted to a forthcoming scientific meeting.

MediciNova and Avigen Confirm Stockholder Election Deadline

Tue, 15 Dec 2009

SAN DIEGO and ALAMEDA, Calif., Dec 15, 2009 (GlobeNewswire via COMTEX) -- MediciNova, Inc., a biopharmaceutical company that is publicly traded on the Nasdaq Global Market (Nasdaq:MNOV) and the Hercules Market of the Osaka Securities Exchange (Code Number:4875) and Avigen, Inc. (Nasdaq:AVGN), a biopharmaceutical company, confirmed today that, as previously announced, Avigen stockholders that wish to make an election with respect to the merger consideration to be received in the proposed acquisition by MediciNova of Avigen must deliver a properly completed election form to American Stock Transfer & Trust Company, LLC by 5:00 p.m., Eastern Time, on December 17, 2009 (the "Election Deadline"), the day of the Special Meeting of Avigen stockholders.

Seattle Genetics and Millennium: The Takeda Oncology Company Announce Strategic Collaboration for Novel Late-Stage Lymphoma Program Brentuximab Vedotin (SGN-35)

Tue, 15 Dec 2009

Seattle Genetics to Receive $60 Million Upfront Payment and Retain Full Commercialization Rights to Brentuximab Vedotin in U.S. and Canada; Takeda Group to Commercialize in the Rest of the WorldSeattle Genetics to Host Conference Call December 15, 2009 at 8:30 A.M. Eastern Time

BOTHELL, Wash. & CAMBRIDGE, Mass. & OSAKA, Japan, Dec 15, 2009 (BUSINESS WIRE) -- Seattle Genetics, Inc. (Nasdaq: SGEN) and Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited (TSE: 4502) today jointly announced that Seattle Genetics and Millennium have entered into an agreement to globally develop and commercialize brentuximab vedotin (SGN-35). Brentuximab vedotin is an antibody-drug conjugate (ADC) targeting CD30 that is in late-stage clinical trials for the treatment of relapsed and refractory Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (ALCL).

Isis and Alnylam Announce Notice of Allowance for New U.S. Patent Application Broadly Covering RNAi Therapeutics

Tue, 15 Dec 2009

- New Allowance by U.S. Patent and Trademark Office for "Crooke Patent" Includes Methods of Activating Endogenous Cellular RNA Nucleases with Chemically Modified Double-Stranded RNAs -

CARLSBAD, Calif. & CAMBRIDGE, Mass., Dec 15, 2009 (BUSINESS WIRE) -- Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) and Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) announced today that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. patent application (No. 10/078,949) in the "Crooke" patent family, which broadly covers chemically modified RNA-containing therapeutics. Specifically, the allowed Crooke application includes 75 claims covering methods of using chemically modified double-stranded RNA-containing compounds to activate an RNA nuclease (RNase). The activation of the endogenous cellular RNase "argonaute 2" by double-stranded small interfering RNAs (siRNAs) is a central step in RNAi, resulting in the sequence-specific cleavage of target mRNA.

StemCells, Inc. Strengthens Patent Position in Embryonic and Induced Pluripotent Stem Cell Technology Platforms

Tue, 15 Dec 2009

PALO ALTO, Calif., Dec 15, 2009 (BUSINESS WIRE) -- StemCells, Inc. (NASDAQ:STEM) announced today that it has received a Notice of Allowance and a Notice of Issuance from the U.S. Patent and Trademark Office for two patents claiming technologies for the establishment and maintenance of cell pluripotency (the ability to become any cell in the body, which is the defining attribute of embryonic stem cells), including the reprogramming of cells to create pluripotent stem cells. These patents strengthen the Company's intellectual property position in both the induced pluripotent stem (iPS) cell and embryonic stem (ES) cell fields, and reflect the value that StemCells continues to derive from its April 2009 acquisition of the operating business of Stem Cell Sciences Plc.

Data Safety Monitoring Board (DSMB) Approves Advancement to Intermediate Dose Level of PLX-PAD

Tue, 15 Dec 2009

HAIFA, Israel--(BUSINESS WIRE)--Pluristem Therapeutics Inc. (NasdaqCM: PSTI) (DAX: PJT) today announced that the independent DSMB approved the advancement to the intermediate dose level of the company’s placenta derived cell therapy, PLX-PAD, in the Phase I clinical trial in Europe for the treatment of critical limb ischemia (CLI), the end stage of peripheral artery disease (PAD).

Ablynx Initiates Phase I For ALX-0141 (ANTI-RANKL)

Mon, 14 Dec 2009

GHENT, Belgium, 14 December 2009 - Ablynx [Euronext Brussels: ABLX] announced today that it has initiated a double-blind, randomised, placebo-controlled Phase I study with ALX-0141, a Nanobody® targeting Receptor Activator of Nuclear Factor kappa B Ligand (RANKL), in healthy postmenopausal women.

XOMA Presents Advantages of Its Multiple Antibody Formulation Technologies at Antibody Engineering Conference

Mon, 14 Dec 2009

BERKELEY, Calif., Dec 10, 2009 (GlobeNewswire via COMTEX News Network) -- XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, reported results demonstrating the advantages of its monoclonal antibody technologies in the rapid development of a first-in-class multiple antibody product candidate, XOMA 3AB. XOMA 3AB is designed to neutralize botulinum neurotoxin Type A, which causes paralysis and is a bioterror threat. The results were presented at the 20th Annual International Conference on Antibody Engineering being held December 6 to 10 in San Diego, CA.

Celldex Therapeutics Presents Positive Results from Phase 2 Study of the Antibody-Drug Conjugate (ADC) Product Candidate CDX-011 in Advanced Breast Cancer

Mon, 14 Dec 2009

NEEDHAM, Mass.--(BUSINESS WIRE)--Dec. 13, 2009-- Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced the results of a positive Phase 2 study of CDX-011 (formerly CR011-vcMMAE), in patients with heavily pre-treated, locally advanced or metastatic breast cancers. As presented today at the 32nd Annual CTRC-AACR San Antonio Breast Cancer Symposium, the primary efficacy endpoint for the study has been met with significant antitumor activity in patients whose tumors express the target GPNMB. In addition, encouraging results were seen in patients with “triple-negative disease” where treatment options are relatively limited due to lack of hormone receptor or HER2-neu expression.

ChemGenex Announces Licensing and Development Agreement with European Partner, Hospira

Mon, 14 Dec 2009

December 14, 2009: ChemGenex Pharmaceuticals Limited (ChemGenex) (ASX:CXS) will host an investor briefing teleconference tomorrow, Tuesday 15th December at 11:00am Australian Eastern Daylight Savings Time (Monday 14th December 4:00pm U.S. Pacific Time).

ChemGenex CEO Dr. Greg Collier will update investors on the development and commercialization agreement that ChemGenex has signed with Hospira Inc. for the commercialization of omacetaxine in Europe, the Middle East and parts of Africa.

ARIAD Announces Updated Data from Clinical Trial of Its Investigational mTOR Inhibitor, Ridaforolimus, In Combination with Trastuzumab

Mon, 14 Dec 2009

SAN ANTONIO, Dec 14, 2009 (BUSINESS WIRE) -- ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA) today announced the presentation of updated clinical data from its Phase 2 study evaluating oral ridaforolimus in combination with trastuzumab (Herceptin(R)) in patients with resistant, metastatic breast cancer. As assessed by the study investigators, the clinical trial met its primary endpoint of objective response rate. The data were presented last Friday, December 11, at 5:30 p.m. C.T. at the annual San Antonio Breast Cancer Symposium in San Antonio, Texas. ARIAD is developing ridaforolimus, an investigational mTOR inhibitor, in collaboration with its partner, Merck & Co, Inc.

EntreMed Reports Receipt of Third Quarter Royalty Payment

Mon, 14 Dec 2009

ROCKVILLE, MD, December 11, 2009 – EntreMed, Inc. (Nasdaq: ENMD), today announced the receipt of $1.7 million in royalty revenue from sales of Thalomid® during the third quarter compared to estimated royalty revenue of $3.3 million. In addition, the Company anticipates a decrease in fourth quarter and projected revenue for fiscal 2009. The difference in estimated and actual revenues for the third quarter will be reflected in the fourth quarter financial results.

Dendreon Announces Pricing of Common Stock Offering

Fri, 11 Dec 2009

SEATTLE, December 10, 2009 - Dendreon Corporation (Nasdaq: DNDN) announced today that it has priced its underwritten public offering of 15,000,000 shares of its common stock at a price to the public of $24.75 per share. Dendreon also granted to the underwriters a 30-day option to purchase up to an additional 2,250,000 shares of common stock to cover overallotments, if any. The offering is expected to close on December 15, 2009, subject to customary closing conditions.

Seattle Genetics Announces Termination of Collaboration Agreement with Genentech for Dacetuzumab (SGN-40)

Fri, 11 Dec 2009

SEATTLE--(BUSINESS WIRE)--Dec. 11, 2009-- Seattle Genetics, Inc. (Nasdaq: SGEN) today reported that it has been notified by Genentech, a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), that Genentech has elected to terminate the companies’ collaboration agreement for dacetuzumab (SGN-40). Dacetuzumab is a monoclonal antibody targeting CD40 that has been investigated in clinical trials for non-Hodgkin lymphoma and multiple myeloma. The decision is a result of Genentech’s ongoing portfolio review process.

Allos Therapeutics' FOLOTYN Shows Activity in a Dose Finding Phase 1 Study of Relapsed or Refractory Cutaneous T-Cell Lymphoma

Thu, 10 Dec 2009

Named One of the "Best of ASH" Presentations at the ASH Annual Meeting

NEW ORLEANS & WESTMINSTER, Colo., Dec 08, 2009 (BUSINESS WIRE) -- Allos Therapeutics, Inc. (NASDAQ: ALTH) today announced updated data from its ongoing dose finding Phase 1 study of FOLOTYN(TM) (pralatrexate injection) in patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL). These data were showcased during an oral presentation at the 51st Annual Meeting of the American Society of Hematology (ASH) in New Orleans, LA.

Opexa Therapeutics, Inc. Announces $5.1 Million Securities Offering

Thu, 10 Dec 2009

THE WOODLANDS, Texas--(BUSINESS WIRE)--Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company developing a novel T-cell therapy for multiple sclerosis (MS), today entered into definitive agreements with institutional investors in a direct placement with gross proceeds of $5.1 million. The offering is made pursuant to the Form S-3 shelf registration statement that was filed by Opexa with the Securities and Exchange Commission (the “SEC”) and declared effective by the SEC on November 23, 2009. The offering is expected to close on or about December 14, 2009, subject to the satisfaction of customary closing conditions. Opexa intends to use the net proceeds from the offering for general corporate purposes, including activities related to further clinical development of Tovaxin® and for other working capital and operational purposes.

Neurocrine Announces Top-Line Results From 703 Study (Tulip PETAL Study) of Elagolix for Treatment of Endometriosis Pain

Wed, 9 Dec 2009

Primary Efficacy and Safety results consistent with previous studies
Company to host conference call and webcast today at 5:00PM ET / 2:00PM PT

SAN DIEGO, Dec 09, 2009 /PRNewswire-FirstCall via COMTEX/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced top-line efficacy and safety results from the Tulip PETAL Study (703 Study), its fifth Phase 2 clinical trial using its proprietary, orally-active nonpeptide Gonadotropin-Releasing Hormone (GnRH) receptor antagonist, elagolix, in patients with endometriosis.

Cortex Receives Delisting Notification from NYSE Amex

Wed, 9 Dec 2009

IRVINE, Calif.--(BUSINESS WIRE)--Cortex Pharmaceuticals, Inc. (NYSE Amex: COR) announced that it has received notification from the NYSE Amex LLC indicating that, due to the Company’s non-compliance with certain continued listing standards as previously reported, the Exchange intends to delist the Company’s common stock from the NYSE Amex effective as of the close of business on Friday, December 11, 2009. Cortex appealed an earlier delisting determination by the NYSE Amex, but was unable to regain compliance within the allotted timeframe provided by the Exchange.

Upon the Company’s delisting of its common stock from the NYSE Amex, the Company believes that its securities will be eligible for quotation on the OTC Bulletin Board. Cortex intends to continue to comply with its Securities and Exchange Commission filing obligations.

XOMA Announces NASDAQ Matter Resolved With Letter of Reprimand

Wed, 9 Dec 2009

No Change in Listing Status

BERKELEY, Calif., Dec 9, 2009 (GlobeNewswire via COMTEX News Network) -- XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced that it received a Letter of Reprimand from the staff of The NASDAQ Stock Market LLC on December 8, 2009 for non-compliance with NASDAQ's Listing Rule 5635(d)(2) in connection with XOMA's previously-announced common share financing completed on September 30, 2009. The issuance of this letter completed the NASDAQ staff's review of the matter which was referenced in the previously-disclosed November 13, 2009 letter to XOMA. XOMA's common shares will remain listed on The NASDAQ Global Market.

Dendreon Announces Proposed Public Offering of Common Stock

Wed, 9 Dec 2009

SEATTLE, December 8, 2009 - Dendreon Corporation (Nasdaq: DNDN) announced today that it has commenced an underwritten public offering, subject to market and other conditions, of 15,000,000 shares of its common stock pursuant to an effective shelf registration statement. Dendreon intends to grant to the underwriters a 30-day option to purchase up to an additional 2,250,000 shares of common stock to cover over-allotments, if any. J. P. Morgan Securities Inc. and Deutsche Bank Securities Inc. will act as joint book-running managers of the offering.

Dynavax's European Manufacturing Facility Approved for Commercial Production of HEPLISAV Hepatitis B Surface Antigen

Wed, 9 Dec 2009

BERKELEY, CA and DUSSELDORF, GERMANY, Dec 09, 2009 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that its GMP manufacturing facility in Duesseldorf, Germany has been approved for the commercial production of hepatitis B surface antigen, a key component of HEPLISAV(TM), the Company's investigational adult hepatitis B vaccine. The approval comes as a result of an upgrade expanding production capacity. With an updated European Union GMP manufacturing license in place, Dynavax can meet the initial commercial production demands for the anticipated launch of HEPLISAV.

ASA404 to feature in Novartis Oncology Pipeline Update and at San Antonio Breast Cancer Symposium

Wed, 9 Dec 2009

ASA404 to feature in Novartis Oncology Pipeline Update and at San Antonio Breast Cancer Symposium

London, UK, Cambridge, MA, and Basel, Switzerland: 9 December 2009 – Antisoma plc (LSE: ASM; USOTC: ATSMY) announces that Novartis, its partner for ASA404, will feature ASA404 in today’s Oncology pipeline update for investors. A webcast will be available via the Novartis website at www.novartis.com

Novo A/S Implements 10b5-1 Trading Plan for Purchase of Additional BioMimetic Therapeutics Shares

Wed, 9 Dec 2009

FRANKLIN, Tenn., Dec 08, 2009 (BUSINESS WIRE) -- BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) and Novo A/S announced that on December 8, 2009, Novo A/S implemented a 10b5-1 trading plan, providing for open market purchases of BioMimetic common stock. Any transactions involving the Company's securities under the plan will be reported and disclosed as required by applicable securities laws.

Currently, Novo A/S beneficially owns approximately 17% of the common stock of BioMimetic. Thorkil Christensen, CFO of Novo A/S and a member of BioMimetic's board of directors, noted that, "Novo does not intend to increase its ownership in BioMimetic in excess of 25%, nor does it intend to seek to acquire or exercise control over the company. Novo intends to purchase additional securities pursuant to the announced program for investment purposes."

Sunesis Presents Positive Phase 2 Clinical Data of Voreloxin in Acute Myeloid Leukemia at the American Society of Hematology 2009 Annual Meeting

Tue, 8 Dec 2009

Conference Call Scheduled for December 8 at 2:00 PM EST to Discuss ASH Data Presentations

SOUTH SAN FRANCISCO, CA, Dec 07, 2009 (MARKETWIRE via COMTEX News Network) -- Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today announced positive data from two Phase 2 clinical trials of the Company's lead drug candidate, voreloxin. The results highlight voreloxin's strong efficacy and safety profile when used as a single agent or in combination with chemotherapy in patients with difficult to treat acute myeloid leukemia (AML). The trial results were presented at the 51st American Society Hematology (ASH) Annual Meeting in New Orleans, LA. The presentations are available on the Sunesis website at www.sunesis.com.

ARIAD Presents Positive Clinical Proof-of-Concept Data on AP24534 in Drug-Resistant Hematological Cancers at ASH Annual Meeting

Tue, 8 Dec 2009

- First results of safety and clinical activity against broad spectrum of BCR-ABL mutations
- Evidence of clinical anti-tumor activity in resistant and refractory patients

NEW ORLEANS--(BUSINESS WIRE)--Dec. 7, 2009-- ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced positive clinical data from an ongoing Phase 1 study of its investigational, pan-BCR-ABL inhibitor, AP24534, in patients with advanced hematological cancers. The data provide strong clinical evidence of hematologic, cytogenetic and molecular anti-cancer activity of AP24534, a multi-targeted kinase inhibitor, in heavily pretreated patients with resistant and refractory chronic myeloid leukemia (CML), including those with the T315I mutation of the target protein, BCR-ABL. The data are being presented this afternoon at the 51^st Annual Meeting of the American Society of Hematology (ASH) being held in New Orleans, LA.

Pharmacyclics, Inc. Announces Presentation of Interim Results From Phase I Trial of Its First-In-Human Btk Inhibitor PCI-32765

Tue, 8 Dec 2009

NEW ORLEANS and SUNNYVALE, Calif., Dec 07, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Pharmacyclics, Inc. (Nasdaq: PCYC) today announced interim data from a Phase I study of their novel orally administered Bruton's tyrosine kinase (Btk) inhibitor PCI-32765 in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) or chronic lymphocytic leukemia (CLL). These data are being presented at the American Society of Hematology (ASH) 51st Annual Meeting taking place this week in New Orleans, LA.

Adamis Pharmaceuticals Announces Signing of Definitive Merger Agreement with La Jolla Pharmaceutical

Mon, 7 Dec 2009

SAN DIEGO--(BUSINESS WIRE)--Adamis Pharmaceuticals Corporation (OTCBB: ADMP), announced today that it has entered into a definitive merger agreement providing for the acquisition of La Jolla Pharmaceutical Company (NASDAQ: LJPC) by Adamis. The transaction was unanimously approved by the boards of directors of both companies and is anticipated to close by the end of the first calendar quarter of 2010 or as soon thereafter as possible. Completion of the transaction is subject to a number of customary closing conditions, including the effectiveness of a registration statement to be filed with the Securities and Exchange Commission relating to the transaction, and approval of Adamis’ and La Jolla’s respective stockholders at stockholder meetings following distribution of a definitive joint proxy statement. After completion of the merger, the combined company expects to trade under the name “Adamis Pharmaceuticals Corporation”.

Seattle Genetics Reports Positive Data from Phase I Weekly-Dosing Clinical Trial of Brentuximab Vedotin (SGN-35) in Lymphoma

Mon, 7 Dec 2009

-65 percent of patients who received weekly brentuximab vedotin doses of 0.8 mg/kg and higher achieved an objective response-

SEATTLE, Dec 07, 2009 (BUSINESS WIRE) -- Seattle Genetics, Inc. (Nasdaq: SGEN) today reported data from a phase I weekly-dosing clinical trial of brentuximab vedotin (SGN-35), an antibody-drug conjugate (ADC), including multiple complete and partial remissions in patients with relapsed or refractory Hodgkin lymphoma or systemic anaplastic large cell lymphoma (ALCL). The data were presented at the American Society of Hematology (ASH) 51st Annual Meeting being held in New Orleans, Louisiana.

CytRx Announces Positive Phase 2 Results For Tamibarotene in the Treatment of Relapsed Acute Promyelocytic Leukemia

Mon, 7 Dec 2009

LOS ANGELES--(BUSINESS WIRE)--CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical company, today announced favorable preliminary results from its Phase 2 STAR-1 registration clinical trial for tamibarotene in the treatment of acute promyelocytic leukemia (APL) in patients failing other treatments. The results were presented in a poster at the 51st Annual Meeting of the American Society of Hematology (ASH), being held December 5-8, 2009 at the Ernest N. Morial Convention Center in New Orleans, Louisiana.

AS1413 regimen yields high response rate and durable responses in patients with secondary AML, a poor-risk population underserved by current treatment options

Mon, 7 Dec 2009

London, UK, Cambridge, MA, and New Orleans, LA: 7 December 2009 – Antisoma plc (LSE: ASM; USOTC: ATSMY) announces that positive final data from a phase II trial of AS1413 in patients with secondary acute myeloid leukaemia (secondary AML) were presented this weekend at the American Society of Hematology (ASH) meeting in New Orleans. Follow-up of patients has now been completed, and full results are available:

Eighty-eight patients with secondary AML received the novel DNA intercalator AS1413 together with cytarabine as first-line (remission-induction) therapy
The remission rate was 42%, with 39% of patients achieving a complete remission and 3% a complete remission with incomplete bone marrow recovery
The median duration of remission was 9.4 months, and 30% of those who achieved remission were still alive 2 years after treatment
Clinical benefit was maintained in older patients, with patients over 60 achieving remission rates and remission durations similar to those of patients under 60
Median survival for all patients was 6.6 months
The safety profile of the regimen was manageable and acceptable, and consistent with that expected for AML remission-induction therapy

Pharmacyclics, Inc. Reports Interim Safety and Clinical Data from a Phase I/II Clinical Trial of its Oral HDAC Inhibitor PCI-24781 in Lymphoma

Sun, 6 Dec 2009

NEW ORLEANS and SUNNYVALE, Calif., Dec 06, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Pharmacyclics, Inc. (Nasdaq: PCYC) today announced interim results from a Phase I/II study showing safety and clinical activity in patients with relapsed / recurrent non-Hodgkin's Lymphoma (NHL) treated with its HDAC inhibitor PCI-24781 as a single agent. The data were presented today at the 51st ASH Annual Meeting being held in New Orleans, LA (Abstract # 2726).

Idera Pharmaceuticals Appoints Rahul Jasuja, Ph.D., Vice President of Corporate Development

Fri, 4 Dec 2009

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec. 4, 2009-- Idera Pharmaceuticals, Inc. (Nasdaq: IDRA), a biotechnology company engaged in the discovery and development of DNA- and RNA-based drug candidates targeted to Toll-like Receptors (TLR), announced today the appointment of Rahul Jasuja , Ph.D., as Vice President of Corporate Development. Dr. Jasuja previously served as Managing Director, Life Sciences at MDB Capital Group, a life sciences and technology Merchant and Investment Bank located in Santa Monica, CA.

StemCells, Inc. Welcomes Approval of First Embryonic Stem Cell Lines Under New NIH Guidelines

Thu, 3 Dec 2009

PALO ALTO, Calif.--(BUSINESS WIRE)--Dec. 3, 2009-- StemCells, Inc. (NASDAQ: STEM) announced today that it welcomes the approval yesterday by the National Institutes of Health (NIH) of the first 13 human embryonic stem cell (hESC) lines for use in NIH-funded research under the NIH Guidelines for Human Stem Cell Research adopted in July 2009. The guidelines implement President Obama’s executive order of March 9, 2009 permitting the federal government, through the NIH, to support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell research. Stem cell research holds the potential to advance the understanding of many diseases at a fundamental, cellular level, and may open new avenues for treatments or cures. The Company considers this action by the federal government as a critical first step for the advancement of the stem cell field and for the future practice of medicine.

Isis Pharmaceuticals Adds Two New Drugs to Development Pipeline

Thu, 3 Dec 2009

ISIS-FXIRx to Treat Clotting Disorders

CARLSBAD, Calif., Dec. 3 /PRNewswire-FirstCall/ -- Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) announced today that it has added two new drugs to its development pipeline, ISIS-FXIRx and ISIS-SMNRx.

Cardium Files FDA 510(k) Application for U.S. Marketing Clearance of ExcellagenXL(TM) Topical Gel and ExcellagenFX(TM) Flowable Collagen Protein-Based Matrix for Diabetic, Pressure and Venous Ulcers and Other Dermal Wounds

Thu, 3 Dec 2009

SAN DIEGO, Dec. 3 /PRNewswire-FirstCall/ -- Cardium Therapeutics (NYSE Amex: CXM) announced today that its wholly-owned subsidiary, Tissue Repair Company, submitted a 510(k) premarket notification filing with the U.S. Food and Drug Administration (FDA) seeking marketing clearance of its Excellagen(TM) product candidate based on positive data from the Company's recently completed Phase 2b Matrix clinical study. Today's submission with the FDA covers ExcellagenXL(TM) and ExcellagenFX(TM), advanced wound care management medical devices comprising customized collagen protein-based topical gels designed for use by health care professionals for patients with dermal wounds, which can include diabetic ulcers, pressure ulcers, venous ulcers, tunneled/undermined wounds, surgical and trauma wounds, second degree burns, and other types of wounds.

Oncolytics Biotech Inc. Announces Exercise of Underwriters’ Over-Allotment Option

Thu, 3 Dec 2009

CALGARY, AB – December 2, 2009 – Oncolytics Biotech Inc. ("Oncolytics" or the “Company”) (TSX:ONC; NASDAQ:ONCY) announced today that in connection with its previously announced unit offering, the underwriters have exercised in full their over-allotment option and purchased an additional 637,500 units. Each unit is comprised of one common share and 0.4 of a common share purchase warrant, and was sold at a price of US$3.00 per unit. Each whole common share purchase warrant entitles the holder to acquire one common share of Oncolytics upon payment of US$3.50 for a five year period ending November 23, 2014, subject to an acceleration of the expiry date in certain circumstances. Oppenheimer & Co. Inc. acted as the sole book-running manager for the offering. Canaccord Capital Corporation and Bloom Burton & Co. acted as Canadian co-managers for the offering.

Peregrine Completes Patient Enrollment in Cotara Dose Confirmation and Dosimetry Brain Cancer Trial

Wed, 2 Dec 2009

-Dosimetry Data Objectives Have All Been Met and Final Data from the Trial Is Expected By Mid-2010
-Completion of Patient Enrollment in the Study Allows the Company to Expand Its Ongoing Cotara Phase II Glioblastoma Clinical Trial

TUSTIN, Calif., Dec 02, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) today reported completion of patient enrollment in a dose confirmation and dosimetry trial of Cotara(R) in patients with relapsed glioblastoma multiforme (GBM), the deadliest form of brain cancer. Cotara is a targeted monoclonal antibody linked to a radioisotope being developed as a potential new treatment for GBM. Cotara specifically targets cells at the center of brain tumors, so its radioactive payload is able to kill cancer cells while leaving healthy tissue largely unaffected. Cotara is also being tested in a Phase II clinical trial in patients with recurrent GBM.

CytRx Announces That FDA Lifts Clinical Hold of Arimoclomol in ALS

Wed, 2 Dec 2009

– Company Permitted to Resume Clinical Testing as FDA Accepts Revised Protocol for Ascending Dose Trial
– Clinical Trial to Include Safety and Efficacy Evaluation

LOS ANGELES--(BUSINESS WIRE)--Dec. 2, 2009-- CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical company, is permitted to re-enter the clinic with its orally administered molecular chaperone drug candidate arimoclomol as a therapeutic treatment for amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease), following the U.S. Food and Drug Administration’s (FDA) acceptance of a revised clinical trial protocol.

Seasoned Clinical Development Expert Joins Opexa to Lead Tovaxin® Development in Multiple Sclerosis

Wed, 2 Dec 2009

Strengthening of Clinical Team Demonstrates Strong Commitment to Tovaxin and Positions Company for Future Development

THE WOODLANDS, Texas--(BUSINESS WIRE)--Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company developing a novel T-cell therapy for multiple sclerosis (MS), today announced that Jaye Thompson, Ph.D. has been hired to lead the Company’s efforts to further the clinical development of Tovaxin^®, Opexa’s flagship therapy for MS. Additionally, Dawn McGuire, M.D., Opexa’s expert clinical advisor and member of the Company’s Clinical Advisory Board has agreed to further increase her advisory role in the Company and to represent Opexa as its acting Chief Medical Officer.

Dyax Announces FDA Approval of KALBITOR(R) (ecallantide) for the Treatment of Acute Attacks of Hereditary Angioedema in Patients 16 Years of Age and Older

Wed, 2 Dec 2009

First Subcutaneous Treatment Approved for HAE

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec. 1, 2009-- Dyax Corp. (NASDAQ:DYAX) announced today that the U.S. Food and Drug Administration (FDA) has granted approval for KALBITOR^® (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older.

Agennix AG Announces Positive Results with Talactoferrin In Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial

Tue, 1 Dec 2009

- Trial results show 45% overall reduction in 28-day all cause mortality with talactoferrin versus placebo

- Talactoferrin again shown to be very well tolerated

- Conference call and webcast scheduled for Wednesday, December 2 at 9 AM ET/3 PM CET

Martinsried/Munich (Germany), Princeton, NJ and Houston, TX, December 1, 2009 - Agennix AG (Frankfurt Stock Exchange: AGX) today reported results from the talactoferrin randomized, double-blind, placebo-controlled Phase 2 trial in severe sepsis. The trial evaluated talactoferrin versus placebo in 190 adult patients with severe sepsis enrolled at 25 leading centers across the U.S. Patients in both arms also received standard of care treatment for severe sepsis in an intensive care unit (ICU) setting. The trial achieved its primary endpoint of a reduction in 28-day all-cause mortality. The trial showed a 45% reduction in the 28-day all-cause mortality from 26.6% in the placebo arm to 14.6% in the talactoferrin arm (two-tailed p-value = 0.04, odds ratio by logistic regression analysis = 0.47).

Pfizer And Protalix Enter Into Agreement To Develop And Commercialize Gaucher's Disease Treatment

Tue, 1 Dec 2009

New Drug Application (NDA) expected to be filed with FDA for novelenzyme replacement therapy with Fast Track Orphan Drug designation

Dec. 1, 2009 (Business Wire) -- Pfizer (NYSE: PFE) and Protalix (NYSE-Amex: PLX) today announced that they have entered into an agreement to develop and commercialize taliglucerase alfa, a plant-cell expressed form of glucocerebrosidase (GCD) in development for the potential treatment of Gaucher’s disease. Under the terms of the agreement, Pfizer will receive exclusive worldwide licensing rights for the commercialization of taliglucerase alfa, while Protalix will retain the exclusive commercialization rights in Israel. Taliglucerase alfa is the first enzyme replacement therapy derived from a proprietary plant cell-based expression platform using genetically engineered carrot cells.

Sunesis to Host Conference Call on Tuesday, December 8th to Discuss New Phase 2 Voreloxin Data Presented at ASH

Tue, 1 Dec 2009

SOUTH SAN FRANCISCO, CA, Dec 01, 2009 (MARKETWIRE via COMTEX News Network) -- Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today announced that the company will host a conference call on Tuesday, December 8, 2009 at 2:00 PM EST to discuss the new clinical data from its Phase 2 voreloxin program presented at the 51st Annual American Society of Hematology (ASH) Meeting in New Orleans. Robert K. Stuart, M.D., Professor of Medicine, Division of Hematology/Oncology, Department of Medicine, Medical University of South Carolina, will join the Sunesis senior management team to review updated data from both its Phase 2 combination study of voreloxin and cytarabine in relapsed or refractory AML patients and the REVEAL-1 study, a Phase 2 dose regimen optimization study of single agent voreloxin in newly diagnosed elderly AML patients who are unlikely to benefit from standard induction chemotherapy.

CytRx Expands Management Team and Broadens Oncology Franchise

Tue, 1 Dec 2009

– Names Industry Veteran Scott Geyer Senior Vice President of Manufacturing

LOS ANGELES--(BUSINESS WIRE)--Dec. 1, 2009-- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical company, continued to broaden its management expertise by naming industry veteran Scott Geyer Senior Vice President of Manufacturing. Mr. Geyer brings more than 28 years of manufacturing and technical operations knowledge overseeing all aspects of product manufacturing in oncology and other fields, including direct experience with small molecules, biologics and topicals.

BioTime, Inc. Announces Third Quarter 2009 Financial Results and Update on Recent Developments

Mon, 30 Nov 2009

-- Records Increase of $9 Million in Shareholders’ Equity
-- Receives First Installment of California-Sponsored Grant Funds
-- Forms Two New Subsidiaries: BioTime Asia and OncoCyte Corporation
-- Common Shares and Warrants Listed on the NYSE Amex --

BioTime, Inc. (NYSE Amex:BTIM) reported financial results for the quarter ended September 30, 2009 and an update.

Affymax Announces Close of Common Stock Offering and Exercise of Underwriters' Overallotment Option

Wed, 25 Nov 2009

PALO ALTO, Calif., Nov 24, 2009 (BUSINESS WIRE) -- Affymax, Inc. (Nasdaq:AFFY) today announced the closing of its underwritten public offering of 4,726,027 shares of its common stock, which includes the full exercise of the underwriter's overallotment option of 616,438 shares. The net proceeds to the company after deducting underwriting discounts and commissions and estimated offering expenses are approximately $80.0 million.

Idera Pharmaceuticals Announces Termination of Asthma and Allergy Research Collaboration Agreement

Wed, 25 Nov 2009

Idera to Regain Full Rights to IMO-2134 (formerly QAX935)

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 25, 2009-- Idera Pharmaceuticals, Inc. (Nasdaq: IDRA), today announced that Novartis will terminate its research collaboration agreement with the Company, effective as of February 21, 2010.

Idera Pharmaceuticals and Merck & Co., Inc. Extend Research Collaboration for Agonists of Toll-like Receptors as Vaccine Adjuvants

Wed, 25 Nov 2009

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 25, 2009-- Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) today announced that Merck & Co., Inc., through an affiliate, has extended its research collaboration with Idera for a fourth year. In December 2006, the companies entered into an exclusive license and research collaboration agreement to research, develop, and commercialize vaccine products containing the Company’s investigational agonist compounds targeting Toll-like Receptors (TLRs) 7, 8, and 9 in the fields of oncology, infectious diseases, and Alzheimer’s disease. As part of the agreement, the two companies engaged in a two-year research and development collaboration to generate novel agonists targeting TLR7 and TLR8 and incorporating both Merck and Idera chemistry for use in vaccines in the licensed fields, with Merck having the right to extend the collaboration for two additional one-year periods.

CytRx Announces Plan to Initiate a Phase 2 Clinical Trial with INNO-206 in Patients with Advanced Soft Tissue Sarcomas

Tue, 24 Nov 2009

– Phase I Clinical Testing with INNO-206 Produced Objective Clinical Responses in Patients with Sarcomas –

LOS ANGELES--(BUSINESS WIRE)--Nov. 24, 2009-- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical company, today announced plans to initiate a multinational Phase 2 clinical trial with its doxorubicin prodrug INNO-206 as a treatment for patients with advanced soft tissue sarcomas who have failed surgery and radiation. Soft tissue sarcomas are cancers that are formed in the muscle, fat, fibrous tissue, blood vessels or other supporting tissue of the body.

Raptor Pharmaceutical Completes DR Cysteamine Phase 2b Clinical Trial in Cystinosis

Tue, 24 Nov 2009

Goal of Trial Achieved Demonstrating Potentially Less Frequent Administration Using Lower Daily Dose

NOVATO, Calif., Nov. 23 /PRNewswire-FirstCall/ -- Raptor Pharmaceutical Corp. ("Raptor" or the "Company") (Nasdaq: RPTP), today announced results from a Phase 2b clinical trial of its proprietary delayed-release cysteamine bitartrate ("DR Cysteamine") in patients with nephropathic cystinosis ("cystinosis"). The trial, conducted at the University of California, San Diego ("UCSD") General Clinical Research Center, evaluated safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of DR Cysteamine in nine cystinosis patients.

Raptor Pharmaceutical Corp. Announces Positive Data on NGX426 in the Potential Treatment of Neuropathic Pain

Tue, 24 Nov 2009

NOVATO, Calif., Nov. 23 /PRNewswire-FirstCall/ -- Raptor Pharmaceutical Corp. ("Raptor" or the "Company") (Nasdaq: RPTP) today announced the presentation of clinical trial data on NGX426, the Company's orally administered, non-opioid, AMPA/kainate receptor antagonist, at the 12th International Conference on the Mechanisms and Treatment of Neuropathic Pain, held on November 20-21 in San Francisco. The results of the study led by Mark Wallace , M.D., Professor of Clinical Anesthesiology at the Center for Pain Medicine of the University of California at San Diego, suggested that NGX426 could be effective in a variety of neuropathic pain states, which are caused by damage to or dysfunction of the peripheral or central nervous system rather than stimulation of pain receptors.

Seattle Genetics and Agensys, an Affiliate of Astellas, Expand Antibody-Drug Conjugate Collaboration

Tue, 24 Nov 2009

BOTHELL, Wash. & SANTA MONICA, Calif.--(BUSINESS WIRE)--Nov. 23, 2009-- Seattle Genetics, Inc. (Nasdaq: SGEN) and Agensys, Inc., an affiliate of Astellas, announced today an expansion of the companies’ antibody-drug conjugate (ADC) collaboration. Under the amended agreement, Agensys will pay a $12 million fee for exclusive rights to ADC licenses against additional antigen targets. Seattle Genetics also receives an option to co-develop another ADC at the time of investigational new drug (IND) submission.

StemCells, Inc. CEO Martin McGlynn Featured On BioBusiness.TV's "Stem Cell Review" Series

Mon, 23 Nov 2009

PALO ALTO, Calif.--(BUSINESS WIRE)--Nov. 23, 2009-- StemCells, Inc. (NASDAQ: STEM) announced today that its president and CEO, Martin McGlynn , was recently featured on BioBusiness.TV’s “Stem Cell Review” discussing the Company’s therapeutic product development programs, including the promise of human neural stem cells and the broad potential application of the Company’s lead product candidate, HuCNS-SC^® cells, in a variety of central nervous system (CNS) disorders. The Stem Cell Review is a 10-part series produced by BioBusiness.TV that covers the science, medical applications, and business of stem cells, and features leading authorities in the field.

Mr. McGlynn’s interview is part of the Stem Cell Review’s Episode 7: Neuronal Stem Cells and CNS disorders. The segment can be viewed online at http://biobusiness.tv/videos/219 and may also be accessed through the Company’s website at www.stemcellsinc.com.

Poniard Announces $7.4 Million Financing

Mon, 23 Nov 2009

SAN FRANCISCO, Nov 23, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Poniard Pharmaceuticals (Nasdaq: PARD) today announced the sale of 3,465,878 of its common shares to Azimuth Opportunity Ltd. for gross proceeds of approximately $7.4 million, or approximately $2.15 per share, under its existing committed equity financing facility with Azimuth. The Company intends to use the $7.3 million in net proceeds from this sale to focus on regulatory and partnering activities for picoplatin, clinical development, other general corporate purposes and working capital. Based on its cash reserves, including the net proceeds from this offering, Poniard believes it has sufficient cash resources to meet its anticipated net cash needs to mid-2010.

Ablynx Receives €1.1 Million Grant to Further Develop New Routes of Administration for Nanobodies

Mon, 23 Nov 2009

GHENT, Belgium, 23 November 2009 - Ablynx [Euronext Brussels: ABLX], announced today that it has been awarded a grant worth €1.1 million by the Flemish agency for Innovation by Science and Technology (IWT).

Cleveland BioLabs Opens Enrollment of Second Safety Study for CBLB502

Mon, 23 Nov 2009

BUFFALO, NY, Nov 23, 2009 (MARKETWIRE via COMTEX) -- Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced the opening of enrollment for the second human safety study for CBLB502, a drug under development for the treatment of Acute Radiation Syndrome (ARS).

CBLB502 is being developed by Cleveland BioLabs under the U.S. Food and Drug Administration's Animal Efficacy Rule to treat Acute Radiation Syndrome (ARS) or radiation poisoning from any exposure to radiation such as a nuclear or radiological weapon / dirty bomb, or from a nuclear accident. This approval pathway requires demonstration of efficacy in representative animal models and safety and drug metabolism testing in healthy human volunteers.

Raptor Pharmaceutical Corp. Announces Positive Data on NGX426 in the Potential Treatment of Neuropathic Pain

Mon, 23 Nov 2009

RXi Pharmaceuticals Wins 2009 RNAi Technology Innovation of the Year Award from Frost & Sullivan

Mon, 23 Nov 2009

WORCESTER, Mass.--(BUSINESS WIRE)--Nov. 23, 2009-- RXi Pharmaceuticals Corporation (Nasdaq: RXII), a biopharmaceutical company pursuing the development and commercialization of proprietary therapeutics based on RNA interference (RNAi), today reported that the Company has received Frost & Sullivan’s 2009 North American RNAi Therapeutic Design & Delivery Technology Innovation of the Year Award for the development of its proprietary RNAi compounds, rxRNA™, and advanced delivery approaches. The rxRNA™ compounds are designed specifically for therapeutic use and contain many of the properties needed to develop RNAi-based drugs.

Isis Pharmaceuticals (Nasdaq: ISIS) Letter to Shareholders

Mon, 23 Nov 2009

StemCells, Inc. Initiates Landmark Trial Targeting "Communication Highway" of the Brain

Mon, 23 Nov 2009

Study Being Conducted at UCSF Children's Hospital

PALO ALTO, Calif., Nov 23, 2009 (BUSINESS WIRE) -- StemCells, Inc. (NASDAQ: STEM) announced today that it has commenced patient recruitment for a Phase I clinical trial designed to test the safety and preliminary efficacy of its HuCNS-SC(R) purified human neural stem cells in Pelizaeus-Merzbacher Disease (PMD), a neurological disorder that primarily afflicts children. The study is being conducted at the University of California, San Francisco (UCSF) Children's Hospital, one of the leading medical centers in the United States for neonatology, pediatric neurology and neurosurgery.

Agennix AG Reports Financial Results For Third Quarter and First Nine Months of 2009

Mon, 23 Nov 2009

Martinsried/Munich (Germany), Princeton, NJ and Houston, TX, November 23, 2009 - Agennix AG (Frankfurt Stock Exchange: AGX) today announced financial results for the third quarter and first nine months ended September 30, 2009.

Agennix AG was formed by the combination of GPC Biotech AG and Agennix Incorporated. The accounting for the business combination will be based on the acquisition method specified in IFRS 3, Business combinations (revised 2008). Based on that accounting treatment, GPC Biotech AG has been identified as the acquirer and Agennix Incorporated as the acquiree in this transaction. Therefore, the historical financial information of Agennix AG, including the information presented below, is that of GPC Biotech AG. Furthermore, for future financial reports, the comparative historical financial information will be that of GPC Biotech AG for the respective comparative periods.

BioCryst Announces Pricing of Public Offering of Common Stock

Fri, 20 Nov 2009

BIRMINGHAM, Ala., Nov 19, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the pricing of a public offering of 5,000,000 shares of its common stock at $9.75 per share, resulting in gross proceeds of $48.75 million. All of the shares are being offered by BioCryst pursuant to an effective shelf registration statement previously filed with the Securities and Exchange Commission. BioCryst has also granted the underwriters a 30-day option to purchase up to an aggregate of 750,000 additional shares of common stock to cover over-allotments, if any. Morgan Stanley is acting as the sole book-runner for the offering, with JMP Securities and Oppenheimer & Co. acting as co-managers. The offering is expected to close on November 25, 2009.

XOMA Receives NASDAQ Determination Letter

Thu, 19 Nov 2009

BERKELEY, Calif., Nov 19, 2009 (GlobeNewswire via COMTEX News Network) -- XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced that it received a letter from the staff of The NASDAQ Stock Market LLC on November 13, 2009 indicating that the NASDAQ staff has concluded that XOMA's previously-announced common share financing completed on September 30, 2009 did not comply with NASDAQ's Listing Rule 5635(d)(2). Listing Rule 5635(d)(2) requires that a company obtain shareholder approval for the issuance of common shares or securities exercisable for common shares equal to 20% or more of the common shares outstanding before the issuance for less than the greater of book or market value of the shares. Receipt of this letter has no effect on the current listing status of the common shares.

Dynavax Completes Enrollment of First Cohort of Patients in Phase 1b Clinical Trial for Hepatitis B Therapy

Thu, 19 Nov 2009

BERKELEY, CA, Nov 19, 2009 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that enrollment has been completed for the first of three cohorts of patients receiving DV-601 hepatitis B therapy in a Phase 1b clinical trial. The safety profile of patients in the first cohort met pre-specified criteria for dose escalation and the second cohort has been opened for enrollment. Dynavax expects to report top-line data from this trial in the second half of 2010. DV-601 is the first hepatitis B therapy to combine both the surface and core HBV antigens, and Dynavax has retained all commercial rights to this product.

Ablynx Achieves Third Milestone in Drug Discovery and Development Collaboration

Thu, 19 Nov 2009

GHENT, Belgium, 18 November 2009 - Ablynx [Euronext Brussels: ABLX], announced today that it will receive an undisclosed milestone payment from Novartis. The payment has been triggered by successful delivery to Novartis of Nanobody® candidates which met specific criteria. This will be the third milestone payment that Ablynx has received from Novartis since the initiation of the alliance between the companies.

GTC Biotherapeutics Receives Extension to Regain Compliance with Nasdaq Listing Standards

Thu, 19 Nov 2009

FRAMINGHAM, MA – November 19, 2009 -- GTC Biotherapeutics, Inc. ("GTC", NASDAQ: GTCB) has received from a NASDAQ Hearings Panel an extension to March 16, 2010 to regain compliance with the market value of listed securities requirement for continued listing on The NASDAQ Capital Market, as specified by NASDAQ Listing Rule 5550(b)(2). The Company’s common stock will continue to be listed on The NASDAQ Capital Market during the extension. GTC can satisfy the terms of the Panel’s decision by demonstrating a market value of listed securities of at least $35 million for ten consecutive trading days prior to the end of the extension period.

Pluristem Therapeutics Presents Three Month Follow-Up Data from First Patient to Receive Placental Derived PLX-PAD at Two Meetings in Germany and France

Thu, 19 Nov 2009

HAIFA, Israel--(BUSINESS WIRE)--Pluristem Therapeutics Inc. (NasdaqCM:PSTI) (DAX:PJT) today announced that it will present three month follow-up data from the first patient to receive PLX-PAD at both the 1^st Annual Conference of the German-Israeli Life Science Committee at the Life Science Center in Düsseldorf, Germany and at the DigestScience Congress in Lille, France. The patient is participating in a Phase I dose-escalating clinical trial in Europe with PLX-PAD, the company’s leading product candidate for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD).

AVI BioPharma, Inc. Presents Update on AVI-4658 at TREAT-NMD / NIH International Conference

Thu, 19 Nov 2009

BOTHELL, WA — November 19, 2009 — AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based drugs, today announced presentations on the company’s exon skipping therapy for Duchenne muscular dystrophy at the TREAT-NMD / NIH International Conference taking place Nov. 17-19 in Brussels, Belgium

At the conference, data from the company’s clinical and preclinical programs were presented. An update on the company’s ongoing systemic Phase 1b/2 trial of AVI-4658 was provided by Professor Francesco Muntoni, of the MDEX consortium in the UK, during an oral presentation and also summarized in a poster presentation. The most recent data from the ongoing Phase 1b/2 trial at two MDEX sites in the UK demonstrate that AVI-4658 was well tolerated by DMD patients in a dose escalation study that is now up to the sixth and final cohort (20 mg/kg). The maximum cumulative dose administered to date is 3132 mg and the maximum single dose is 900 mg with no adverse safety signals, in either case.

Affymax Announces Proposed Public Offering of Common Stock

Thu, 19 Nov 2009

PALO ALTO, Calif., Nov 18, 2009 (BUSINESS WIRE) -- Affymax, Inc. (Nasdaq: AFFY), today announced that it intends to offer, subject to market and other conditions, shares of its common stock in an underwritten public offering. Affymax expects to grant the underwriters a thirty-day option to purchase additional shares of common stock to cover overallotments, if any.

Sunesis Reports Data From Nonclinical Studies of Voreloxin at AACR-EORTC-NCI Conference

Wed, 18 Nov 2009

SOUTH SAN FRANCISCO, CA, Nov 18, 2009 (MARKETWIRE via COMTEX News Network) -- Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today reported data from two nonclinical studies of voreloxin at the AACR-EORTC-NCI Molecular Targets and Cancer Therapeutics Conference, which is being held in Boston, MA from November 15-19, 2009.

In one study, clinical proof-of-mechanism is established in samples from patients treated with voreloxin in the Company's ongoing Phase 2 clinical study of voreloxin in combination with cytarabine in relapsed or refractory acute myeloid leukemia (AML). In an additional study, voreloxin's synergistic and additive effects are demonstrated in combination with cytarabine, azacitidine, decitabine and clofarabine, agents which are currently used in the treatment of AML. Results from both of these studies support the current combination study and identify potential opportunities for further clinical evaluation.

Peregrine Pharmaceuticals Presents Promising Antiviral Data at 2009 Chemical and Biological Defense Science & Technology Conference

Wed, 18 Nov 2009

- In Preclinical Studies, Peregrine's PS-Targeting Antibodies Including Bavituximab Demonstrated Broad Spectrum Binding to Viruses and Virally Infected Cells Representing Three Viral Hemorrhagic Fever (VHF) Families -
- Preclinical Efficacy Studies Showed that a Single Dose of PS-Targeting Antibodies Increased the Survival of Hamsters Lethally Infected with VHF Viruses -
- Bavituximab is Also Currently Being Evaluated in a Phase I Clinical Trial in Patients Co-infected with HCV and HIV -

TUSTIN, Calif., Nov 18, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) today announced that researchers presented positive data on progress in its federally funded preclinical viral hemorrhagic fever (VHF) program, confirming that its phosphatidylserine (PS)-targeting antibodies bind to VHF viruses and virally infected cells and increase survival in a model of lethal VHF infection. The data were presented at the 2009 Chemical and Biological Defense Science and Technology (CBD S&T) Conference in Dallas, Texas.

Exelixis Reports Encouraging Phase 1 Data for the PI3K Inhibitor Xl147 (SAR245408) in Combination with Erlotinib at the AACR-NCI-EORTC Conference

Wed, 18 Nov 2009

BOSTON--(BUSINESS WIRE)--Nov. 18, 2009-- Exelixis, Inc. (Nasdaq:EXEL) today reported interim data from an ongoing phase 1 dose-escalation trial of XL147 (SAR245408) in combination with the EGFR inhibitor erlotinib in patients with advanced solid tumors. XL147 is a selective, orally available small molecule inhibitor of phosphoinositide-3-kinase (PI3K). Activation of the PI3K pathway is a frequent event in human tumors, promoting cell proliferation, survival, and resistance to chemotherapy and radiotherapy. The pathway also has been implicated as a mediator of resistance to epidermal growth factor receptor (EGFR) inhibitors. Neil Faulkner , MD from the Karmanos Cancer Institute, Wayne State University, Detroit, MI, an investigator on the phase 1 trial, will present the data in a poster session (Abstract #C197) beginning at 12:30 pm, local time, on Wednesday, November 18, 2009, at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, which is being held November 15-19 in Boston. XL147 is being developed with sanofi-aventis.

Cleveland BioLabs Publishes New Insights Into Mechanism of Action of Curaxins, Extending Their Clinical Potential

Wed, 18 Nov 2009

BUFFALO, NY, Nov 18, 2009 (MARKETWIRE via COMTEX) -- Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that a breakthrough discovery into the mechanism of action of the Company's first generation Curaxin anticancer compounds was published in an international health science journal, Cell Cycle (Neznanov et al., Cell Cycle 8:23, 1-11; December 1, 2009).

The published study examined the ability of the Company's prototype Curaxin (CBLC102, or quinacrine) to inhibit heat shock response, a major adaptive pro-survival pathway that rescues cells from stressful conditions involving accumulation of misfolded proteins (known as proteotoxic stress). Tumor cells typically become dependent on constitutive activity of this salvaging mechanism making them selectively susceptible to its inhibitors, especially if applied in combination with certain cancer therapies provoking proteotoxic stress.

BioCryst Announces Proposed Public Offering of Common Stock

Wed, 18 Nov 2009

BIRMINGHAM, Ala., Nov 17, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that it is offering to sell, subject to market and other conditions, 5,000,000 shares of its common stock pursuant to an effective shelf registration statement in an underwritten public offering. BioCryst also intends to grant the underwriters a 30-day option to purchase up to an aggregate of 750,000 additional shares of common stock to cover over-allotments, if any. All of the shares in the offering are to be sold by BioCryst. Morgan Stanley will be acting as the sole book-runner for the offering, with JMP Securities and Oppenheimer & Co. acting as co-managers.

StemCells, Inc. Provides Update on NCL Program Meeting with FDA

Wed, 18 Nov 2009

StemCells, Inc. Provides Update on NCL Program Meeting with FDA

PALO ALTO, Calif.--(BUSINESS WIRE)--Nov. 18, 2009-- StemCells, Inc. (NASDAQ: STEM) today provided an update on the ongoing clinical development program of its proprietary HuCNS-SC^® product candidate (purified human neural stem cells) for neuronal ceroid lipofuscinosis (NCL), often referred to as Batten disease.

CytRx to Initiate Phase 2 Clinical Trial with INNO-206 in Patients with Advanced Gastric Cancer

Wed, 18 Nov 2009

– Second Leading Cause of Cancer Death Worldwide Represents a Major Market for CytRx –

– INNO-206 Has Demonstrated Significant Tumor Shrinkage in Animal Models for a Wide Array of Cancer Indications –

LOS ANGELES--(BUSINESS WIRE)--Nov. 18, 2009-- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical company, today announced plans to initiate an open-label, multinational Phase 2 clinical trial with its doxorubicin prodrug INNO-206 as a second-line treatment in patients with advanced gastric (stomach) cancer.

CytRx President and CEO Steven A. Kriegsman said, “This planned clinical trial is a key step forward in our plans to build a commercial oncology franchise for CytRx. We have studied the oncology market in solid tumors and believe that stomach cancer represents a major market and an unmet medical problem worldwide. We have also been encouraged by exciting animal data for INNO-206 in a broad array of cancer indications, and are hopeful that this carefully-designed study will bring hope to the sufferers of advanced gastric cancer.”

Alnylam Presents New Pre-clinical Data on ALN-VSP, an RNAi Therapeutic for the Treatment of Liver Cancer

Wed, 18 Nov 2009

- New Results Demonstrate Robust Anti-Tumor Activity in Multiple Models, Including Extra-Hepatic Tumors -

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 18, 2009-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, today announced new pre-clinical data from its ALN-VSP program presented at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics International conference being held November 15 - 19, 2009 in Boston, Mass. ALN-VSP is an RNAi therapeutic currently in a Phase I clinical trial for the treatment of liver cancers, including hepatocellular carcinoma (HCC) and other solid tumors with liver involvement. The new data demonstrated robust anti-tumor activity in orthotopic liver tumor models comprised of both HCC- and colorectal cancer-derived cell lines. ALN-VSP was also shown to act on disseminated tumors outside of the liver. Further, in addition to anti-proliferative effects, studies showed that ALN-VSP exerts a potent anti-angiogenic effect on tumors.

Poniard Pharmaceuticals Announces Updated Positive Clinical Data from Phase 2 Trial of Picoplatin in Colorectal Cancer and New Phase 1 Cardiac Safety Trial Results

Tue, 17 Nov 2009

- Data Presented at AACR-NCI-EORTC's "Molecular Targets and Cancer Therapeutics" International Conference -

SOUTH SAN FRANCISCO, Calif., Nov 17, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD) today announced updated clinical data from its randomized, controlled Phase 2 trial of picoplatin in patients with metastatic colorectal cancer (CRC). The updated results indicated that picoplatin, given once every four weeks in combination with 5-fluorouracil and leucovorin in the FOLPI regimen, has comparable efficacy to oxaliplatin, given in combination with 5-fluorouracil and leucovorin in the modified FOLFOX-6 regimen, as a first-line therapy for CRC, as assessed by one-year survival rate, progression-free survival (PFS) and disease control. The Company also announced new results from its Phase 1 cardiac safety trial, which showed no clinical cardiac-related events, as expected.

Exelixis Reports Encouraging Phase 1 Data for the PI3K Inhibitor XL147 (SAR245408) in Combination with Paclitaxel and Carboplatin at the AACR-NCI-EORTC Conference

Tue, 17 Nov 2009

BOSTON--(BUSINESS WIRE)--Nov. 17, 2009-- Exelixis, Inc. (Nasdaq:EXEL) today reported interim data from an ongoing phase 1 dose-escalation trial of XL147 (SAR245408) in combination with paclitaxel and carboplatin in patients with advanced solid tumors. XL147 is a selective, orally available small molecule inhibitor of phosphoinositide-3-kinase (PI3K). Activation of the PI3K pathway is a frequent event in human tumors, promoting cell proliferation, survival, and resistance to chemotherapy and radiotherapy. Upregulation of PI3K signaling is associated with resistance to paclitaxel and carboplatin. Jennifer Wheler , MD from the University of Texas M. D. Anderson Cancer Center, Houston, TX, and an investigator on the phase 1 trial, will present the data in a poster session (Abstract #B247) beginning at 12:30 pm, local time, on Tuesday, November 17, 2009, at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, which is being held November 15-19 in Boston. XL147 is being developed with sanofi-aventis.

Oncolytics Biotech Inc. Collaborators Present Positive Phase I/II Trial Results in Advanced Solid Cancers with a Focus on the Head and Neck at the AACR-NCI-EORTC Meeting

Tue, 17 Nov 2009

CALGARY, AB, November 17, 2009 --- Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) (“Oncolytics” or the “Company”) today announced updated results from a Phase I/II U.K. trial (REO 011) of REOLYSIN® combined with paclitaxel/carboplatin for patients with advanced cancers in a poster presentation at the 2009 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics conference being held in Boston, Massachusetts. The poster presentation is entitled “Phase I/II Trial of Oncolytic Reovirus (REOLYSIN) in Combination with Carboplatin/Paclitaxel in Patients with Advanced Solid Cancers with Emphasis on Squamous Cell Carcinoma of the Head and Neck (SCCHN).”

The investigators reported that REOLYSIN was well tolerated when administered intravenously in combination with paclitaxel and carboplatin. Of 19 evaluable patients with head and neck cancer, mostly SCCHN refractory to prior platinum-based chemotherapy for recurrent/metastatic disease, eight experienced partial responses and six had stable disease. The total clinical benefit rate (complete response + partial response + stable disease) observed in head and neck cancer patients in the trial was 74%. Of four patients with malignant melanoma on the trial, one experienced a partial response and one had stable disease.

XOMA Appoints Jim Neal Vice President of Business Development

Tue, 17 Nov 2009

BERKELEY, Calif., Nov 17, 2009 (GlobeNewswire via COMTEX News Network) -- XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today announced that James R. Neal has joined the company as Vice President, Business Development. Mr. Neal will oversee XOMA's business development strategy and lead the team to execute key licensing initiatives to build and support XOMA's proprietary therapeutic pipeline and biodefense programs, to market the company's antibody technologies and to assess commercial opportunities and develop product candidates commercially.

ChangeWave issues BUY recommendation on Access Pharmaceuticals

Tue, 17 Nov 2009

DALLAS, TX., November 17, 2009 - ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP) today announced that a recommendation report was issued by ChangeWave, a research network that identifies emerging trends and companies best-positioned to capitalize in today’s marketplace. The report was written by Mr. Joshua Levine, Editor of ChangeWave Investing and ChangeWave MicroCap Investor.

According to Mr. Levine, “Finally, with MuGard now commercialized, Access is already receiving its first royalties, and cash flow will steadily ramp up in the coming quarters. Since MuGard has pharmaceutical-type margins, it will instantly impact Access’ financial situation. The increase in revenue will provide financial security for this company with an active partnering and outsourcing model and a very small $3 million-a-year burn rate.”

Pluristem Therapeutics Announces Three Month Follow-Up Data from the First Patient to Receive PLX-PAD

Tue, 17 Nov 2009

HAIFA, Israel--(BUSINESS WIRE)--Pluristem Therapeutics Inc. (NasdaqCM:PSTI) (DAX:PJT) today announced that safety and potential efficacy parameters were demonstrated by the three month follow up data from the first patient ever to receive its placenta derived cell therapy product, PLX-PAD. The patient is participating in a Phase I dose-escalating clinical trial in Europe with PLX-PAD, the company’s leading product candidate for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD).

BioCryst Announces Proposed Public Offering of Common Stock

Tue, 17 Nov 2009

Sunesis Reports Financial Results for the Third Quarter of 2009

Mon, 16 Nov 2009

Voreloxin Abstracts Accepted for Presentation at ASH

SOUTH SAN FRANCISCO, CA, Nov 16, 2009 (MARKETWIRE via COMTEX News Network) -- Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today reported financial results for the third quarter ended September 30, 2009. Sunesis also announced that two abstracts related to the voreloxin clinical program in Acute Myeloid Leukemia (AML) have been accepted for presentation at the 51st Annual Meeting of the American Society of Hematology (ASH), scheduled for December 5 - 8, 2009 in New Orleans.

EntreMed Reports Third Quarter 2009 Financial Results

Mon, 16 Nov 2009

ROCKVILLE, MD – November 16, 2009 – EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer, today reported results for the three- and nine-month periods ending September 30, 2009.

Revenues for the third quarter 2009 were approximately $3,668,000 versus $3,501,000 for the comparable period a year ago. The Company reported a net income for the third quarter of approximately $85,000. This compares with a net loss of approximately ($3.4 million), or ($0.04) per share for the same period last year.

RXi Pharmaceuticals Reports Financial Results for the Third Quarter of 2009

Mon, 16 Nov 2009

WORCESTER, Mass.--(BUSINESS WIRE)--Nov. 16, 2009-- RXi Pharmaceuticals Corporation (Nasdaq: RXII), a biopharmaceutical company pursuing the development and commercialization of proprietary therapeutics based on RNA interference (RNAi), today reported its financial results for the quarter ended September 30, 2009.

“RXi continues to make excellent progress advancing its RNAi therapeutic platform, most notably self-delivering rxRNA™ compounds for both local and systemic administration,” said Noah Beerman , President and Chief Executive Officer of RXi. “We have reported positive pre-clinical data that outline the unique capabilities of our technology and how RXi is addressing important factors that we believe will lead to the successful development and eventual commercialization of RNAi therapeutics. With my successful track record of building a pipeline of biopharmaceutical products, I believe RXi should be well positioned to capitalize on these opportunities.”

Poniard Pharmaceuticals Announces Pivotal Phase 3 SPEAR Trial of Picoplatin in Small Cell Lung Cancer Did Not Meet Primary Endpoint

Mon, 16 Nov 2009

- Company to Host Conference Call and Webcast Today at 8:00 a.m. ET -

SOUTH SAN FRANCISCO, Calif., Nov 16, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD) today announced that its pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial of picoplatin in the second-line treatment of small cell lung cancer (SCLC) did not meet its primary endpoint of overall survival. The analysis, based on 320 evaluable events (patient deaths), showed a hazard ratio of 0.82 with a p value of 0.089.

Soligenix Reports Third Quarter 2009 Financial Results

Fri, 13 Nov 2009

Princeton, NJ – November 13, 2009 – Soligenix, Inc., (Soligenix or the Company) (OTC BB: SNGX), formerly known as DOR BioPharma, Inc., a late-stage biotechnology company, announced today its financial results for the third quarter of 2009.

XOMA 052 Selected as a Top Ten Project to Watch

Fri, 13 Nov 2009

BERKELEY, Calif., Nov 12, 2009 (GlobeNewswire via COMTEX News Network) -- XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of antibody therapeutics, announced its anti-inflammatory antibody to interleukin-1 beta (IL-1 beta), XOMA 052, has been selected as a Top Ten Cardiovascular/metabolic Project to Watch for partnering opportunities. The selection was made by Windhover and Elsevier Business Intelligence, the leading provider of business intelligence and analysis in the pharmaceutical, biotechnology and medical device industries.

Bradmer Announces 2009 Third Quarter Financial Results

Thu, 12 Nov 2009

TSX: BMR

TORONTO, Nov. 12 /CNW/ - Bradmer Pharmaceuticals Inc. ("Bradmer" or the "Company") today announced its 2009 third quarter financial results.

Dendreon Reports Third Quarter 2009 Financial Results and Continuing Progress Toward PROVENGE Commercialization

Thu, 12 Nov 2009

Conference Call to be Hosted Today at 4:30 p.m. EST

SEATTLE, November 11, 2009 - Dendreon Corporation (Nasdaq: DNDN) today reported results for the quarter ended September 30, 2009. Revenue for the third quarter of 2009 was $25,000 compared to $26,000 for the quarter ended September 30, 2008. Revenue for the nine months ended September 30, 2009 was $80,000 compared to $83,000 for the nine months ended September 30, 2008.

Dendreon's total operating expenses for the third quarter of 2009 were $25.8 million compared to $17.3 million in 2008. Dendreon's total operating expenses for the nine months ended September 30, 2009 were $63.7 million compared to $55.1 million for the same period in 2008.

Alnylam Provides Update on RNAi Pipeline, Platform, and Technology at Its R&D Day

Thu, 12 Nov 2009

- Update on Pipeline Includes New Pre-clinical In Vivo Data Demonstrating that ALN-TTR Blocks Pathogenic Tissue Deposition of Mutant TTR Protein by Greater than 95% -
- Update on Delivery Platform Includes Research on Discovery of Novel Lipid Nanoparticles with Improved Gene Silencing Potency at Doses Less than 30 Micrograms per Kilogram -
- Update on Technology Efforts Includes New Data on Applications of RNAi in Biologics Manufacturing, Creating New Business Opportunity -

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 12, 2009-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, is providing an update on its RNAi pipeline, platform, and technology at its R&D Day being held in New York today. Alnylam scientists and management will be joined by two guest speakers: Professor Allan Glanville , Director of Thoracic Medicine and Medical Director Lung Transplantation, St. Vincent’s Hospital, Sydney, will discuss respiratory syncytial virus (RSV) infection in the lung transplant patient population; and Professor Philip N. Hawkins , National Amyloidosis Centre, Division of Medicine, and University College London Medical School, Royal Free Hospital, will discuss transthyretin (TTR)-mediated amyloidosis (ATTR). Alnylam is developing RNAi therapeutics for the treatment of both RSV infection and ATTR, amongst other pipeline programs.

CombiMatrix Corporation Reports Third Quarter 2009 Financial Results

Wed, 11 Nov 2009

MUKILTEO, Wash., Nov 11, 2009 (GlobeNewswire via COMTEX News Network) -- CombiMatrix Corporation (Nasdaq:CBMX) today reported financial results for the three and nine months ended September 30, 2009. Key highlights for the third quarter and through the date of this release include:

30% increase in diagnostic lab revenues from Q3-2008 to Q3-2009
Progress in litigation regarding $36 million verdict to CombiMatrix
Sequentially flat diagnostic lab product and service revenues from Q2-2009 to Q3-2009
Leuchemix clinical trials progressing well
Continued progress in company's Comprehensive Cancer Array test currently in development

Geron Collaborators Publish Data on hESC-Derived Glial Progenitor Cell Therapy in Cervical Spinal Cord Injury

Wed, 11 Nov 2009

Data Provide Preclinical Proof-of-Concept to Support Clinical Development of GRNOPC1 in Patients With Cervical Spinal Cord Injuries

MENLO PARK, Calif.--(BUSINESS WIRE)--Geron Corporation (Nasdaq:GERN) today announced the publication of data showing that oligodendrocyte progenitor cells (OPCs) derived from human embryonic stem cells (hESCs), when transplanted into a rodent model of cervical spinal cord injury, reduced tissue damage within the lesion and improved recovery of locomotor function. These data provide preclinical proof-of-concept for the use of GRNOPC1, Geron’s hESC-derived oligodendrocyte progenitor product, in patients with cervical spinal cord injuries. Over half of the 11,000 human spinal cord injuries that are sustained in the U.S. annually are in the cervical region.

Access Pharmaceuticals Provides Update on MuGard Commercial Launch in North America

Wed, 11 Nov 2009

European Launch Ongoing– Initial Clinician And Patient Feedback Very Positive

DALLAS, TX, November 11, 2009

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), today provided an update on its North American commercial launch of MuGard, an FDA approved treatment for oral mucositis, a debilitating side effect of radiation treatment and chemotherapy.

New Study in Clinical Cancer Research Shows Therapeutic Promise of Peregrine's Bavituximab With Radiation in a Lethal Brain Cancer Model

Tue, 10 Nov 2009

- Treatment in Combination with Radiation Doubled Survival Time and Produced Long-Term Cures in Lethal Brain Cancer Model -
- Confirms PS-Targeting Antibodies Have a Dual Mechanism of Action that Both Destroys Tumor Blood Vessels and Initiates a Robust Immune Response to the Tumor -
- New Studies Demonstrate Therapeutic Potential of Bavituximab in Brain Cancer In Addition to Ongoing Phase II Trials in Advanced Breast and Lung Cancers -

TUSTIN, Calif., Nov 10, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHMD) today announced that a newly published study shows that a phosphatidylserine (PS)-targeting antibody similar to the company's lead product candidate bavituximab demonstrated potent anti-tumor activity when combined with radiation in a model of aggressive brain cancer, doubling the survival time of test animals and producing long-term cures. The study also provides further evidence that the anti-cancer activity of bavituximab and other PS-targeting antibodies reflects multiple novel mechanisms. Bavituximab is currently in Phase II clinical trials for the treatment of advanced breast cancer and advanced lung cancer. The new study is available in the current on-line edition of Clinical Cancer Research(1).

Cardium Reports on Third Quarter 2009 Financial Results and Recent Developments

Tue, 10 Nov 2009

SAN DIEGO, Nov 10, 2009 /PRNewswire-FirstCall via COMTEX/ -- Cardium Therapeutics (NYSE Amex: CXM) today reported its financial results for its third quarter ended September 30, 2009, and on recent developments and future outlook. Cardium made significant progress since its second quarter 2009 financial report and highlights included:

--  Sale of Cardium's InnerCool Therapies business to Royal Philips
        Electronics;
    --  Completion and announcement of data from the Matrix Phase 2b clinical
        trial of Excellarate(TM) for the potential treatment of non-healing
        diabetic ulcers and the Company's plans to meet with the FDA to review
        the data and proposed outline for a Phase 3 clinical study;
    --  Plans for the commercial development of a new product candidate
        Excellagen(TM), a collagen-based topical gel, through a FDA 510(k)
        clearance pathway for potential use by physicians in patients with
        topical wounds, which include diabetic ulcers as well as pressure
        ulcers, venous ulcers, surgical and trauma wounds, second degree burns,
        and other types of wounds;
    --  Publication of positive findings from the open label multi-center Phase
        1/2 Excellarate clinical study in the October 2009 issue of Wound Repair
        and Regeneration, a peer-reviewed journal of the Wound Healing Society;
    --  Plans to develop a DNA-based orthobiologics product portfolio based on a
        reformulation of the Company's Excellarate product candidate that will
        initially focus on non-union bone fractures and spinal fusions;
    --  Publication of preclinical research published in the scientific journal,
        Gene Therapy, demonstrating the potential benefits of the Cardium's Gene
        Activated Matrix technology for accelerating and enhancing periodontal
        tissue repair and oral implant osseointegration;
    --  Completion of two registered direct investments of Cardium's common
        stock by institutional investors with gross proceeds totaling $10.5
        million;
    --  Listing compliance with the NYSE Amex.

Dynavax to Acquire Symphony Dynamo, Inc., Including $20 Million in Unrestricted Cash

Tue, 10 Nov 2009

Proceeds Fund HEPLISAV Registration Trials

BERKELEY, CA, Nov 10, 2009 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that it has exercised its option to purchase all of the equity of Symphony Dynamo, Inc. (SDI). As a result, Dynavax will acquire approximately $20 million in cash and regain all rights to its hepatitis C and cancer therapy programs. The transaction, described below, is subject to Dynavax stockholder approval, and is expected to close in the first quarter of 2010.

"This transaction is an important milestone for Dynavax, providing approximately $20 million in cash to fund HEPLISAV(TM), which represents the majority of the funding needed for the Phase 3 registration trials for our investigational adult hepatitis B vaccine," commented Dino Dina, M.D., President and Chief Executive Officer of Dynavax. "Our Hepatitis C clinical program, funded through SDI, has demonstrated safety and reproducible antiviral activity in a Phase 1b trial. With Symphony, we have decided to seek partners for HCV and focus our resources on HEPLISAV."

Compugen Announces Discovery of Genetic Biomarker for Predisposition to Type 2 Diabetes

Mon, 9 Nov 2009

Biomarker Discovered Using Compugen’s GeneVa^® Platform

TEL AVIV, Israel--(BUSINESS WIRE)--Compugen Ltd. (NASDAQ:CGEN) announced today the discovery and experimental confirmation of a genetic biomarker, CGEN-40001 for predisposition to type 2 diabetes, the most common form of diabetes. This new biomarker was discovered using Compugen’s GeneVa^® platform, which consists of an in silico database of approximately 350,000 predicted genetic variations in the human genome, with each predicted variation consisting of multiple consecutive nucleotides.

AVI BioPharma Announces Third Quarter 2009 Financial Results & Corporate Highlights

Mon, 9 Nov 2009

AVI-4658 for Duchenne Muscular Dystrophy in Final Cohort and on Track for Interim Data; Cook's Global Therapeutics Has No Further Plans to Develop AVI-5126 in Drug Eluting Stent

BOTHELL, WA — November 9, 2009 — AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based drugs, today reported financial results for the three and nine months ending September 30, 2009. The Company will host a conference call today, Monday, November 9, at 9:30 a.m. Eastern time (6:30 a.m. Pacific) to review its financial results and corporate highlights (see below for details).

CytRx Reports 2009 Third Quarter Financial Results

Mon, 9 Nov 2009

LOS ANGELES--(BUSINESS WIRE)--Nov. 9, 2009-- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical company, today reported financial results for the three months and nine months ended September 30, 2009.

“We are taking actions that support our focus on developing our considerable oncology assets, which we believe offer the greatest near-term potential to produce revenue and drive stockholder value," said Steven A. Kriegsman , CytRx President and CEO. “Recently Dr. Daniel Levitt joined CytRx as Chief Medical Officer with leadership responsibility over all our drug development programs. Dan has an extensive success record in oncology drug development and commercialization, and in his brief tenure at CytRx has become an integral part of our operations and is invigorating all aspects of our organization.

XOMA Reports 2009 Third Quarter Financial Results

Mon, 9 Nov 2009

BERKELEY, Calif., Nov 9, 2009 (GlobeNewswire via COMTEX News Network) -- XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today announced its financial results for the third quarter and nine months ended September 30, 2009 and provided a general business update. XOMA has made significant progress in 2009 toward its objective of becoming a company focused on proprietary product development and has done so while generating revenues from its technology licensing collaborations, royalties and biodefense businesses in difficult circumstances that included the removal of royalty generating RAPTIVA(R) from the market and a particularly challenging economic environment. The following are XOMA's key accomplishments in 2009.

DX-88 (ecallantide) Demonstrated Relief of Symptoms in Hereditary Angioedema Acute Attacks in All Attack Locations

Mon, 9 Nov 2009

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 7, 2009-- An analysis demonstrating the ability of DX-88 (ecallantide) to resolve symptoms of acute hereditary angioedema (HAE) attacks in all anatomic locations and to sustain effect will be presented in an oral presentation this week at the American College of Allergy, Asthma and Immunology (ACAAI) 2009 Annual Meeting in Miami Beach. This evaluation, and two others to be presented, highlight efficacy and safety analyses from the integrated analysis of the two Phase 3 placebo-controlled trials, EDEMA3^® and EDEMA4^®, of DX-88, the lead product candidate of Dyax Corp. (NASDAQ:DYAX), for the treatment of acute attacks of HAE.

Successful Bone Marrow Regeneration In Cancer Patients Using Cord Blood Expanded By Proprietary Stem Cells

Mon, 9 Nov 2009

“Off-the-shelf” proprietary stem cells expand umbilical cord blood by 40-fold
Transplantation of expanded cord blood results in safe, successful, and rapid bone marrow regeneration
Potential of therapy to reduce infection, bleeding, and death
Major unmet medical need expected to facilitate accelerated product registration

Melbourne, Australia; 6 November 2009: Australian regenerative medicine company, Mesoblast Limited (ASX:MSB), today announced successful results from the first 18 patients receiving a bone marrow transplant using umbilical cord blood expanded by the patented allogeneic, or "off-the-shelf", Mesenchymal Precursor
Cells (MPCs).

Agennix AG Shares Begin Trading on Frankfurt Stock Exchange

Mon, 9 Nov 2009

Martinsried/Munich (Germany), Princeton, N.J. and Houston, TX, November 6, 2009 - Agennix AG (Frankfurt Stock Exchange: AGX) today announced that its shares have begun trading on the Prime Standard of the Frankfurt Stock Exchange under the symbol AGX. The Company also provided an update on its business. As previously announced, additional details will be discussed in a conference call today, November 6, 2009 at 8:00 AM ET/14:00 CET.

Transgenomic, Inc. Reports Third Quarter 2009 Results

Mon, 9 Nov 2009

OMAHA, Neb., November 5, 2009 – Transgenomic, Inc. (OTCBB: TBIO.OB) today announced financial results for the quarter ended September 30, 2009. The Company’s financial results are presented in the tables that follow.

GenVec Reports Third Quarter 2009 Financial Results

Mon, 9 Nov 2009

GAITHERSBURG, Md., Nov. 5 /PRNewswire-FirstCall/ -- GenVec, Inc. (Nasdaq: GNVC) today announced its financial results for the third quarter ended September 30, 2009. GenVec reported a net loss of $3.6 million ($0.04 per share) for the three months ended September 30, 2009 compared to a net loss of $6.8 million ($0.08 per share) in the comparable quarter of 2008. For the nine months ended September 30, 2009, GenVec\'s net loss was $14.1 million ($0.15 per share), compared to a net loss of $19.6 million ($0.24 per share) for the nine months ended September 30, 2008.

BioMimetic Therapeutics Reports 2009 Third Quarter Earnings Results

Mon, 9 Nov 2009

Company’s Second Orthopedic Product Candidate Enters Pivotal Trial for Foot and Ankle Fusion Indications

FRANKLIN, Tenn.--(BUSINESS WIRE)--Nov. 5, 2009-- BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today reported its financial results as of and for the three and nine months ended September 30, 2009. For the three months ended September 30, 2009, the Company reported a net loss of $7.9 million, or $0.36 per diluted share, compared to a net loss of $18.0 million, or $0.97 per diluted share, for the same period in 2008. For the nine months ended September 30, 2009, the Company reported a net loss of $22.3 million, or $1.11 per diluted share, compared to a net income of $4.2 million, or $0.22 per diluted share, for the same period in 2008. The Company ended the third quarter of 2009 with $69.2 million of cash, cash equivalents and short-term investments. The Company also reported $31.4 million in long term investments which includes $29.9 million invested in auction rate securities.

XOMA Expands Development Strategy for XOMA 052 to Include Cardiovascular Diseases

Fri, 6 Nov 2009

BERKELEY, Calif., Nov 6, 2009 (GlobeNewswire via COMTEX News Network) -- XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced the expansion of its development strategy for its XOMA 052 antibody to interleukin-1 beta (IL-1 beta) to include effects on cholesterol lowering, reducing plaque deposits and damage to heart muscle and resulting long-term effects that can lead to heart attack, stroke and congestive heart failure. The strategy is supported by results from XOMA 052 Phase 1 trials demonstrating improvement in biomarkers associated with cardiovascular risk, ongoing clinical trials in cardiovascular disease with other IL-1 targeted agents, animal studies with XOMA 052 that have demonstrated significant reductions in plaque formation and improvements in lipid levels, and positive results with another IL-1 targeted agent in an animal model of cardiac remodeling after heart attack. XOMA's current XOMA 052 program is focused on Type 2 diabetes and this expansion represents an enormous increase in the number of patients who could be helped by this general anti-inflammatory approach.

RXi Pharmaceuticals Appoints Noah D. Beerman as CEO

Fri, 6 Nov 2009

Business Veteran Brings to RXi a Successful Track Record of Building a Pipeline of Biopharmaceutical Products

WORCESTER, Mass.--(BUSINESS WIRE)--Nov. 6, 2009-- RXi Pharmaceuticals Corporation (Nasdaq: RXII), a biopharmaceutical company pursuing the development and commercialization of proprietary therapeutics based on RNA interference (RNAi), today announced that Noah D. Beerman has joined the company as its new President and Chief Executive Officer. The appointment of Mr. Beerman as CEO is part of a planned succession in leadership as the company looks to advance from the research stage to product development and execution of therapeutic collaborations and partnerships. He succeeds RXi’s co-founder, Tod Woolf , Ph.D., who will continue as a member of RXi’s Scientific Advisory Board (SAB).

Mr. Beerman (47) joins RXi with over 25 years of experience in the biopharmaceutical industry and most recently served as Executive Vice President, Chief Business Officer for Indevus Pharmaceuticals, Inc., which was acquired by Endo Pharmaceuticals in March 2009 for $370 million plus future milestone payments. At Indevus, Mr. Beerman was responsible for the development and implementation of the company’s corporate development strategy to ensure near- and long-term growth and success. Noah was also responsible for overseeing Indevus’ acquisition of Valera Pharmaceuticals in 2007 and for managing the integration activities with Endo as part of this transaction.

ARIAD Reports Third Quarter 2009 Development Progress and Financial Results

Thu, 5 Nov 2009

~ SUCCEED Trial Full Patient Enrollment On Track for Year-end 2009

~ Proof-of-Concept Clinical Data of AP24534 to be Presented at ASH

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 5, 2009-- ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported financial results for the third quarter and nine months ended September 30, 2009 and provided an update on corporate developments.

Sunesis' Voreloxin Receives FDA Orphan Drug Designation for Acute Myeloid Leukemia

Thu, 5 Nov 2009

SOUTH SAN FRANCISCO, Calif., Nov 05, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today announced that the U.S. Food and Drug Administration has granted voreloxin orphan drug designation for the treatment of acute myeloid leukemia (AML). Sunesis is currently conducting two Phase 2 clinical trials of voreloxin in AML: a single-agent study, known as REVEAL-1, of voreloxin in newly diagnosed elderly AML patients unlikely to benefit from standard induction chemotherapy and a study evaluating voreloxin in combination with cytarabine in relapsed/refractory AML.

Regulus, Alnylam, and Isis Announce First microRNA Patent Grant in Japan from Tuschl III Patent Series

Thu, 5 Nov 2009

– Tuschl III Patent Exclusively Licensed from Max Planck –

CARLSBAD, Calif. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sep. 17, 2009-- Regulus Therapeutics Inc., Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), and Isis Pharmaceuticals, Inc. (Nasdaq: ISIS), announced today that the Japan Patent Office (JPO) has notified the Max Planck Society of its intent to grant a patent from the Tuschl III patent series (JP Application Number 2003-532675). This patent series pertains to the discovery of over 120 novel mammalian microRNAs, including miR-122, which is a leading pre-clinical program at Regulus. The grant of this first Tuschl III patent in Japan extends the scope of this patent estate, which has already yielded patents in the U.S. (U.S. Patent No. 7,232,806) and in Australia (Australian Patent No. 2002 347 035).

Affymax and Takeda Announce Hematide™ Publication in the New England Journal of Medicine

Thu, 5 Nov 2009

Phase 2 Data of Investigational Drug, Hematide, Suggest Its Ability to Restore Hemoglobin in Patients With Pure Red Cell Aplasia

PALO ALTO, Calif., & DEERFIELD, Ill., Nov 04, 2009 (BUSINESS WIRE) -- Affymax, Inc. (Nasdaq:AFFY) and Takeda Pharmaceutical Global Research & Development Center, Inc., today announced data from a Phase 2 clinical trial of Hematide(TM) showing that Hematide increased hemoglobin and reduced or eliminated the need for blood transfusion in most patients with erythropoietin-induced pure red cell aplasia (PRCA). The data were published in the 5th November 2009 issue of the New England Journal of Medicine.

Isis Reports Financial Results and Highlights for Third Quarter of 2009

Thu, 5 Nov 2009

Conference Call Webcast Thursday, November 5, 08:30 a.m. EST at www.isispharm.com

CARLSBAD, Calif., Nov. 5 /PRNewswire-FirstCall/ -- Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) today announced its financial results for the third quarter ended September 30, 2009. For the quarter, Isis reported a net loss of $3.4 million and a net operating loss of $6.9 million. In addition, for the first nine months of 2009, Isis reported net income of $170.3 million and a net operating loss of $6.1 million. Isis is confident that it will meet its 2009 financial guidance of more than $145 million of net income and a net operating loss in the low to mid $20 million range. All amounts exclude non-cash stock compensation. Isis ended the third quarter with $607.8 million of cash, cash equivalents and short-term investments. Consistent with its guidance and based on its existing and committed cash, Isis expects that its 2009 year-end cash balance will be greater than $550 million.

Idera Pharmaceuticals Reports Third Quarter 2009 Financial Results and Provides Pipeline Update

Thu, 5 Nov 2009

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 5, 2009-- Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) today reported financial results for the third quarter and nine months ended September 30, 2009.

“We have continued development of our pipeline of drug candidates targeted to Toll-like receptors for potential applications in chronic hepatitis C virus infection and autoimmune diseases, and to support our partnered programs in oncology, respiratory disease, and vaccine adjuvants,” said Sudhir Agrawal , D. Phil., President, Chief Executive Officer and Chief Scientific Officer. “We are pleased to have presented clinical data of IMO-2055 in renal cell cancer and in non-small cell lung cancer. We look forward to presenting data from our ongoing clinical trials of IMO-2125 in HCV patients.”

“With $46.1 million in cash, cash equivalents and investments at the end of the third quarter 2009, we are in a strong financial position to continue advancing our clinical and preclinical programs. Due to the receipt of milestone and other payments from our partnered programs, our cash, cash equivalents and investments have decreased by only $9.5 million for the nine months ended September 30, 2009,” added Lou Arcudi , Chief Financial Officer.

Opexa Therapeutics Reports Third Quarter 2009 Financial Results and Corporate Update

Thu, 5 Nov 2009

THE WOODLANDS, Texas--(BUSINESS WIRE)--Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company developing a novel T-cell therapy for multiple sclerosis (MS), today reported financial results for the quarter ended September 30, 2009, and provided details on further developments.

Recent highlights include:

3^rd quarter net income of $2.2 million as a consequence of the gain on the sale of the Company’s stem cell technology;
Closing of sale of early stage adult stem cell technology to Novartis and achievement of first technology transfer milestone; and
Receipt of approximately $1.2 million in additional cash from warrant exercises before and after quarter end.

Alnylam Presents New Pre-Clinical Data on RNAi Therapeutics at Oligonucleotides Therapeutics Society (OTS) Meeting

Thu, 5 Nov 2009

– Research Findings Include Rational Design of Mimetic Lipoprotein Particles (MLPs), a Novel Delivery Technology, New Data Regarding Potency of RNAi-Mediated Gene Silencing, and an Update on RNA Activation Research Efforts –

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 5, 2009-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that it presented new data related to its overall delivery research efforts including the rational design of Mimetic Lipoprotein Particles, or MLPs, a novel technology for the systemic delivery of small interfering RNAs, or siRNAs, the molecules that mediate RNAi. In addition, Alnylam scientists and collaborators presented additional new data on systemic delivery and provided an update on RNA activation (RNAa) technology. These new data were presented at the 5^th Oligonucleotide Therapeutics Society/19^th Antisense Joint Symposium held November 3-6, 2009 in Fukuoka, Japan.

StemCells, Inc. Reports Third Quarter Financial Results

Thu, 5 Nov 2009

PALO ALTO, Calif.--(BUSINESS WIRE)--Nov. 5, 2009-- StemCells, Inc. (NASDAQ:STEM) today reported financial results for the third quarter ended September 30, 2009.

Net loss for the third quarter of 2009 was $5,145,000, or $0.05 per share, compared with a net loss of $5,744,000, or $0.07 per share, in the third quarter of 2008.

Total revenue for the third quarter of 2009 was $253,000, compared to $12,000 for the third quarter of 2008. This revenue growth was primarily driven by the consolidation of the Stem Cell Sciences (SCS) operations, which were acquired in April 2009.

GenVec Signs New Contract to Support HIV and Influenza Vaccine Development

Thu, 5 Nov 2009

GAITHERSBURG, Md., Nov. 5 /PRNewswire-FirstCall/ -- GenVec, Inc. (Nasdaq: GNVC) announced today that SAIC-Frederick, Inc. has signed a contract with GenVec for the development of influenza and HIV vaccines in support of the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). This four-year contract has a total value of over $22 million if all options are exercised. Over the next year, GenVec will receive approximately $2.6 million.

Under the contract, the vaccines would be comprised of genetic material supplied by the VRC and adenoviral vectors supplied by GenVec.

Merger of GPC Biotech AG into Agennix AG Closes

Thu, 5 Nov 2009

Martinsried/Munich (Germany), Princeton, N.J. and Houston, TX, November 5, 2009 – Agennix AG today announced that the merger of GPC Biotech AG into Agennix AG is now completed.

Friedrich von Bohlen und Halbach, Ph.D., Chief Executive Officer of Agennix AG, said: “I am very excited about the promise that the new company holds. Our lead program, talactoferrin, is in two Phase 3 trials for non-small cell lung cancer, an area of major unmet medical need. Agennix has an experienced team that combines the best strengths of the individual merger parties. We are focused on advancing talactoferrin and our other development programs, finding the right development and commercialization partners and ensuring we secure sufficient funding to do this effectively.”

BioCryst Receives First Peramivir Order From U.S. Government

Thu, 5 Nov 2009

BIRMINGHAM, Ala., Nov 05, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced it has received an initial order for 10,000 courses of intravenous (i.v.) peramivir (600 mg once-daily for five days) with a value of $22.5 million under a newly issued contract with the Department of Health and Human Services (HHS). On November 4, BioCryst shipped the entire order from existing i.v. peramivir inventory to HHS.

Peregrine Pharmaceuticals Awarded Second Broad U.S. Patent for Anti-Viral Applications of Phospholipid-Targeting Antibodies

Wed, 4 Nov 2009

--Broad New Patent Covers Peregrine's Lead PS-Targeting Antibody Bavituximab and Similar Agents for the Treatment of All Viral Infections--
--New Patent Covers Applications under Active Development Including HCV Clinical Program and R&D Activities in Viral Hemorrhagic Fever, HIV, CMV and Other Life Threatening Viral Infections--

TUSTIN, Calif., Nov. 4 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHMD - News) today announced that the U.S. Patent and Trademark Office has issued U.S. Patent Number 7,611,704, which includes broad claims covering anti-viral uses of phosphatidylserine (PS)-targeting antibodies including Peregrine's lead clinical compound, bavituximab. PS is a unique marker exposed on the surface of virally infected cells that can be targeted to treat a broad spectrum of virus infections.

Alnylam Pharmaceuticals Reports Third Quarter 2009 Financial Results

Wed, 4 Nov 2009

– Advances Pipeline of RNAi Therapeutics with Phase II Results for ALN-RSV01, Continued Enrollment of ALN-VSP for Liver Cancer, and On Track to File IND for ALN-TTR for TTR-Mediated Amyloidosis –

– Demonstrates Continued Strength of Partnerships, Including Year Five Extension with Novartis and Advanced Collaboration with Roche –

– Provides New Guidance to Initiate Phase IIb Trial of ALN-RSV01 in Lung Transplant Patients and Updates Business Development Goal and Financial Guidance for 2009 –

– Ends Quarter with Approximately $453 Million in Cash –

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 4, 2009-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, today reported its consolidated financial results for the third quarter ended September 30, 2009 and company highlights.

BioCryst's Partner Shionogi Files for Peramivir Regulatory Approval in Japan

Wed, 4 Nov 2009

BIRMINGHAM, Ala., Nov 04, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that its partner, Shionogi & Co., Ltd. has filed a New Drug Application (NDA) in Japan to seek regulatory approval for intravenous (i.v.) peramivir to treat patients with influenza. As a consequence of this filing, BioCryst will receive a regulatory milestone payment of $7 million under its agreement with Shionogi.

BioMimetic Therapeutics Receives First Orthopedic Marketing Approval for Augment™ Bone Graft

Wed, 4 Nov 2009

FRANKLIN, Tenn.--(BUSINESS WIRE)--Nov. 3, 2009-- BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) announced today that it has received approval from Health Canada to begin the marketing of its lead orthopedic product, Augment™ Bone Graft, as an alternative to the use of autograft in midfoot, hindfoot and ankle fusion indications in Canada.

Poniard Pharmaceuticals Reports Third Quarter 2009 Financial Results and Provides a Corporate Update

Wed, 4 Nov 2009

SOUTH SAN FRANCISCO, Calif., Nov 03, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on oncology, today reported financial results for the third quarter ended September 30, 2009, and provided a corporate update.

"During the third quarter, we reached the 320th event target in our pivotal Phase 3 SPEAR trial, which is evaluating picoplatin for the treatment of small cell lung cancer. This event allowed us to collect the data for overall survival analysis," said Jerry McMahon, Ph.D., chairman and chief executive officer of Poniard. "We expect to report top-line results from the SPEAR registration trial this month and plan to present the data at international medical conferences next year. If the top-line results are positive, we plan to initiate a rolling submission of a New Drug Application with the U.S. Food and Drug Administration by year-end, targeting approval and commercial launch of picoplatin in 2010."

Thirteen Abstracts Featuring Exelixis Compounds Accepted for Presentation at the 2009 AACR-NCI-EORTC International Conference

Wed, 4 Nov 2009

Includes Clinical Data for XL147, XL765 and XL139

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Nov. 4, 2009-- Exelixis, Inc. (Nasdaq: EXEL) announced today that thirteen abstracts related to the company’s development candidates have been accepted for presentation at the 2009 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, which is being held November 15-19 in Boston. Interim data from ongoing phase 1 clinical trials of XL147 and XL765 will be reported in four poster presentations. Exelixis is co-developing XL147 and XL765 in collaboration with sanofi-aventis. Clinical data for an ongoing phase 1 trial of XL139, which is being co-developed with Bristol-Myers Squibb, will also be reported. Other poster presentations will cover a variety of preclinical data and preclinical and clinical biomarker data for six compounds.

Alnylam and Roche Advance RNAi Therapeutic Collaboration Phase of Landmark 2007 Alliance

Wed, 4 Nov 2009

– Partners to Co-Develop and Co-Commercialize Certain RNAi Therapeutic Products in U.S. Market –

– Collaboration to Include Alnylam Lipid Nanoparticle and Roche Dynamic Polyconjugate Delivery Technologies –

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 4, 2009-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that it has advanced to the RNAi therapeutic collaboration stage of its landmark alliance with Roche formed in 2007. In this phase of the collaboration, the partners will jointly collaborate on the discovery and development of specific RNAi therapeutic products and each will contribute key delivery technologies in the new disease target-focused effort. New delivery technologies include Alnylam lipid nanoparticles and Roche Madison dynamic polyconjugate delivery technologies. Alnylam and Roche will co-develop and co-commercialize RNAi therapeutic products in the U.S. market and Alnylam is eligible to receive additional milestone and royalty payments for products developed in the rest of world.

Celldex Therapeutics Reports Third Quarter and Nine Month 2009 Financial Results

Wed, 4 Nov 2009

NEEDHAM, Mass.--(BUSINESS WIRE)--Nov. 4, 2009-- Celldex Therapeutics, Inc. (NASDAQ: CLDX) today reported financial results for the third quarter and nine-month period ended September 30, 2009. Celldex reported a net loss of $7.2 million, or $0.45 per share, for the third quarter of 2009 compared to a net loss of $7.7 million, or $0.49 per share, for the third quarter of 2008. For the nine months ended September 30, 2009, Celldex reported a net loss of $23.6 million, or $1.49 per share, compared to a net loss of $40.0 million, or $2.92 per share, for the nine months ended September 30, 2008. At September 30, 2009, Celldex reported cash and cash equivalents of $26.0 million. At September 30, 2009, CuraGen Corporation, which Celldex acquired on October 1, 2009, had cash and investments of $70.3 million and 4% convertible subordinated debt of $12.5 million, due in February 2011.

XOMA Granted First European Patent Covering XOMA 052

Wed, 4 Nov 2009

BERKELEY, Calif., Nov 4, 2009 (GlobeNewswire via COMTEX News Network) -- XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today announced the grant of its first European Patent related to the XOMA 052 program. Granted by the European Patent Office, the patent covers XOMA's interleukin-1 beta (IL-1 beta) antibody XOMA 052, as well as nucleic acids, expression vectors and production cell lines for the manufacture of XOMA 052. The patent provides exclusivity in Europe into 2026.

Phase 2 Trial of XOMA 052 to be Initiated in Type 1 Diabetes Patients

Wed, 4 Nov 2009

BERKELEY, Calif., Nov 4, 2009 (GlobeNewswire via COMTEX News Network) -- XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today announced plans to initiate an investigator sponsored Phase 2 clinical trial of XOMA 052, its antibody to interleukin-1 beta (IL-1 beta), in Type 1 diabetes patients. The trial will be sponsored by the Juvenile Diabetes Research Foundation International (JDRF), the largest patient advocacy organization of Type 1 diabetes research worldwide. The trial sponsor is Dr. Marc Donath, Professor of Endocrinology and Diabetes at the University Hospital of Zurich, pioneer in anti-inflammatory approaches to diabetes treatment, and a principal investigator in the Phase 1 studies of XOMA 052. XOMA will provide XOMA 052 drug product for the trial.

Affymax Names Hollings C. Renton Chairman of the Board of Directors

Tue, 3 Nov 2009

PALO ALTO, Calif., Nov 03, 2009 (BUSINESS WIRE) -- Affymax, Inc. (Nasdaq:AFFY) today announced the appointment of Hollings C. Renton to the position of chairman of the company's board of directors effective December 1, 2009. Mr. Renton replaces Nick Galakatos, who served as lead board member since the company's initial public offering in 2006 and who will be resigning his position as a member of the board of directors at the end of 2009.

Rigel Announces Third Quarter 2009 Financial Results

Tue, 3 Nov 2009

SOUTH SAN FRANCISCO, Calif., Nov. 3 /PRNewswire-FirstCall/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today reported financial results for the third quarter and nine months ended September 30, 2009.

For the third quarter of 2009, Rigel reported a net loss of $26.7 million, or $0.70 per share, compared to a net loss of $37.7 million, or $1.03 per share, in the third quarter of 2008. Weighted average shares outstanding for the third quarters of 2009 and 2008 were 38.1 million and 36.6 million, respectively.

Rosetta Genomics Names Kenneth A. Berlin President and Chief Executive Officer

Tue, 3 Nov 2009

-- 15-Year Johnson & Johnson Veteran to Lead microRNA Company --

REHOVOT, Israel & PHILADELPHIA--(BUSINESS WIRE)--Nov. 3, 2009-- Rosetta Genomics, Ltd. (Nasdaq: ROSG), a leading developer of microRNA-based molecular diagnostics, today announced the appointment of Kenneth A. Berlin to the position of president and chief executive officer, effective November 2, 2009. Rosetta Genomics’ board of directors has recommended that Mr. Berlin also be appointed to serve on the Rosetta Genomics’ board of directors. This recommendation will be put to vote at the Company’s upcoming annual shareholders meeting.

XOMA Signs Antibody Discovery Collaboration With Kaketsuken

Tue, 3 Nov 2009

BERKELEY, Calif., Nov 3, 2009 (GlobeNewswire via COMTEX News Network) -- XOMA Ltd. (Nasdaq:XOMA) and Kaketsuken have entered into a collaboration involving multiple proprietary XOMA antibody research and development technologies, including a new XOMA antibody phage display library, and a suite of integrated information and data management systems. Subject to certain technical verification required under the collaboration agreement, Kaketsuken has agreed to pay XOMA a fee of $8 million and XOMA will be entitled to milestone payments and royalties on product sales. Founded in 1926 in Japan as the Chemo-Sero-Therapeutic Research Institute, Kaketsuken, a research foundation with current annual revenues of approximately US $350 million, has blood plasma products, vaccines and therapeutics and is developing therapeutic solutions for infectious, and other diseases.

StemCells, Inc. Closes $12.5 Million Equity Financing

Tue, 3 Nov 2009

PALO ALTO, Calif.--(BUSINESS WIRE)--Nov. 3, 2009-- StemCells, Inc. (NASDAQ: STEM) announced today that it has closed the sale of 10 million shares of common stock and warrants to purchase four million shares of common stock, for gross proceeds of $12.5 million. The common stock and warrants were sold in units at a price of $1.25 per unit, with each unit consisting of one share of common stock and a warrant to purchase 0.40 share of common stock at an exercise price of $1.50 per share. The units were sold in a registered direct offering under the Company’s effective shelf registration statement previously filed with the Securities and Exchange Commission (SEC). The Company received total proceeds, net of offering expenses and placement agency fees, of $11.9 million. The proceeds will be used for general corporate purposes, including working capital, product development and capital expenditures, as well as for other strategic purposes. At September 30, 2009, the Company had cash, cash equivalents, and marketable debt securities of $33.2 million, and together with the net proceeds of this offering, would have a pro forma cash balance of $45.1 million.

Cardium Announces Plans to File FDA 510(k) Application for U.S. Marketing Clearance of ExcellagenXL(TM) Gel for Diabetic, Pressure and Venous Ulcers and Other Topical Wounds

Mon, 2 Nov 2009

SAN DIEGO, Nov. 2 /PRNewswire-FirstCall/ -- Cardium Therapeutics (NYSE Amex: CXM) today announced plans to submit a 510(k) premarket notification with the U.S. Food and Drug Administration (FDA) seeking marketing clearance of its ExcellagenXL(TM) product candidate. ExcellagenXL is an advanced wound care management medical device, which is a customized collagen-based topical gel designed for use by physicians in patients with topical wounds, which include diabetic ulcers as well as pressure ulcers, venous ulcers, surgical and trauma wounds, second degree burns, and other types of wounds. The Company expects to submit its FDA 510(k) application for ExcellagenXL during the current quarter.

Dendreon Completes Submission of Biologics License Application for PROVENGE

Mon, 2 Nov 2009

SEATTLE (November 2, 2009) - Dendreon Corporation (Nasdaq: DNDN) today announced that it has completed the submission of the amended Biologics License Application (BLA) for PROVENGE® (sipuleucel-T), the Company's lead investigational product, to the U.S. Food and Drug Administration (FDA). Dendreon is seeking licensure for PROVENGE for men with metastatic castrate-resistant prostate cancer (CRPC). If approved by the FDA, PROVENGE would represent the first product in the new therapeutic class known as active cellular immunotherapies.

The amended BLA includes data from the IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) trial, which was conducted under a Special Protocol Assessment agreement with the FDA. The IMPACT study met its pre-specified primary endpoint demonstrating a statistically significant improvement in overall survival in men with metastatic CRPC.

Alnylam Presents New Pre-Clinical Data on ALN-TTR, an RNAi Therapeutic for the Treatment of Transthyretin-Mediated Amyloidosis

Mon, 2 Nov 2009

– New Data Demonstrate Durable In Vivo Efficacy for ALN-TTR –

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 2, 2009-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that it presented new pre-clinical research findings from its transthyretin (TTR)-mediated amyloidosis (ATTR) program at the 60^th Annual Meeting of the American Association for the Study of Liver Diseases (“The Liver Meeting”). Alnylam is developing ALN-TTR, a systemically delivered RNAi therapeutic targeting the TTR gene for the treatment of ATTR, including familial amyloidotic cardiomyopathy (FAC) and familial amyloidotic polyneuropathy (FAP). There are more than 100 mutations that have been identified in the TTR gene. ALN-TTR targets a region of the gene common to wild-type and all known mutant forms of TTR, and therefore, has potential as a therapeutic for all patients with FAC and FAP.

Sunesis Pharmaceuticals Completes Second Tranche of Private Placement

Mon, 2 Nov 2009

SOUTH SAN FRANCISCO, Calif., Nov 02, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today announced the closing of a private placement of $5.0 million of units consisting of convertible preferred stock and common stock warrants on October 30, 2009. This closing constitutes the second tranche of the private placement of up to $43.5 million of Sunesis' securities announced in April 2009. The private placement contemplated the sale of up to $15.0 million of units consisting of convertible preferred stock and warrants to purchase common stock, of which $10.0 million of units were sold in the initial closing in April 2009 and the remaining $5.0 million of units were sold in the second closing held on October 30, 2009. The remaining tranche of up to $28.5 million of common stock may be invested at the election of the holders of a majority of the convertible preferred stock, in their sole discretion, with the date of termination of the preferred stockholders' right to make such an election subject to Sunesis Pharmaceuticals' future cash balance.

LFB Provides $10 Million of Funding to GTC Biotherapeutics LFB

Mon, 2 Nov 2009

LFP Converts Preferred Stock to Common Shares LFP

FRAMINGHAM, MA – November 2, 2009 -- GTC Biotherapeutics, Inc. (“GTC”, NASDAQ: GTCB) announced that LFB Biotechnologies, a wholly owned subsidiary of LFB S.A. (Laboratoire français du Fractionnement et des Biotechnologies S.A., Les Ulis, France) and a strategic shareholder in GTC, has exercised its option to purchase $12.8 million of additional convertible preferred stock under the terms described in the financing agreements approved by GTC shareholders in July 2009. This transaction provides $6.4 million of new cash proceeds to GTC. In addition, LFB has converted the convertible preferred stock it previously purchased under these agreements in July into a total of 10.6 million shares of common stock to support GTC’s market capitalization under NASDAQ’s listing qualification rules. LFB has also entered into agreements with GTC to purchase $3.6 million of common stock at the October 30, 2009 market closing price of $1.07 per share, subject to customary closing conditions. This transaction provides LFB with a further 3.4 million shares of common stock.

Affymax and Takeda Announce Preliminary Phase 2 Data Demonstrated That Hematide™ Increased Hemoglobin in Dialysis Patients

Fri, 30 Oct 2009

Presentations at American Society of Nephrology Renal Week 2009 Characterize Binding, Immunogenicity Profile for Hematide

PALO ALTO, Calif. & DEERFIELD, Ill., Oct 30, 2009 (BUSINESS WIRE) -- Affymax, Inc. (Nasdaq:AFFY) and Takeda Pharmaceutical Global Research & Development Center, Inc., today announced data from multiple clinical and preclinical studies evaluating Hematide, including preliminary results of a Phase 2 trial which demonstrated that Hematide increased hemoglobin levels in a group of anemic hemodialysis (HD) patients. This is the first reported data from an open-label, controlled comparative study of once-monthly Hematide compared to three times per week epoetin alfa (EPO). These results were presented at the American Society of Nephrology (ASN) Renal Week 2009 in San Diego, CA. Separately, Hematide is currently being evaluated in four Phase 3 trials for the treatment of anemia associated with chronic renal failure.

Ablynx Announces Warrant Exercise

Fri, 30 Oct 2009

GHENT, Belgium, 30 October 2009 - Ablynx [Euronext Brussels: ABLX] today announced that an additional 4,407 common shares have been issued by the Company in exchange for €6,732.60 as the result of the exercise of warrants by some employees and consultants of the Company.

As a result of this transaction, Ablynx now has 36,889,789 shares outstanding.

Exelixis Announces Third Quarter 2009 Financial Results

Fri, 30 Oct 2009

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Oct. 29, 2009-- Exelixis, Inc. (Nasdaq:EXEL) today reported financial results for the third quarter ended September 30, 2009.

Revenues for the quarter ended September 30, 2009 were $55.0 million, compared to $29.9 million for the comparable period in 2008. The increase from 2008 to 2009 primarily reflects the increase in revenue relating to our new collaborations with sanofi-aventis for XL147 and XL765, Bristol-Myers Squibb Company for XL184 and XL281 and Boehringer Ingelheim for the S1P1 agonist program partially offset by the conclusion of the research term of various collaboration agreements with GlaxoSmithKline, Bristol-Myers Squibb Company and Genentech.

Sunesis Completes Enrollment of Voreloxin REVEAL-1 Trial in Acute Myeloid Leukemia

Fri, 30 Oct 2009

SOUTH SAN FRANCISCO, Calif., Oct 30, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today reported that it has completed enrollment in the REVEAL-1 (Response Evaluation of VorEloxin in AmL) trial, a Phase 2 dose regimen optimization trial of single agent voreloxin in newly diagnosed elderly acute myeloid leukemia (AML) patients who are unlikely to benefit from standard induction chemotherapy. A total of 113 patients were enrolled and dosed according to one of three dosing schedules.

Dynavax's HEPLISAV Shows Increased Protection Rate for Chronic Kidney Disease Patients

Thu, 29 Oct 2009

First HEPLISAV Chronic Kidney Disease Data to be Presented at IDSA

BERKELEY, Calif., Oct 29, 2009 (BUSINESS WIRE) -- Dynavax Technologies Corporation (Nasdaq: DVAX) today announced the first clinical data for HEPLISAV^TM investigational hepatitis B vaccine in chronic kidney disease patients. These data will be presented in a poster session on Saturday, October 31, 2009 at the 47^th Annual Meeting of the Infectious Disease Society of America (IDSA) in Philadelphia, Pennsylvania.

Vaccinated with HEPLISAV, chronic kidney disease patients demonstrated rapid, increased protection against hepatitis B viral infection in fewer doses than patients receiving licensed vaccine. 96% of patients (n = 36) receiving 3 doses of HEPLISAV achieved seroprotection at month 7, compared to 88% of patients (n = 10) receiving 8 doses of Engerix-B^(R). Dynavax recently began vaccinating chronic kidney disease patients with HEPLISAV in a Phase 3 registration trial.

Oncolytics Biotech Inc. Announces Issuance of 33rd U.S. Patent

Thu, 29 Oct 2009

CALGARY, AB --- October 27, 2009 - Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) (“Oncolytics”) today announced that it has been granted its 33rd U.S. Patent, No. 7,608,257, entitled “Sensitization of Chemotherapeutic Agent Resistant Neoplastic Cells With a Virus.” The patent claims cover methods of using reovirus in combination with currently approved chemotherapeutic agents to treat patients that are refractory to those chemotherapeutic agents alone.

Celldex Therapeutics Presents Positive Clinical Data from Phase 1 Studies of Antibody-Based Cancer Vaccine Candidate, CDX-1307

Thu, 29 Oct 2009

--Data presented at iSBTc meeting; Phase 2 initiation in first quarter 2010--

NEEDHAM, Mass.--(BUSINESS WIRE)--Oct. 29, 2009-- Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced positive results from Phase 1 studies of CDX-1307 in patients with advanced epithelial cancers, including breast, colon, bladder and pancreatic cancer. CDX-1307, the first candidate from the Company’s Precision Targeted Immunotherapy Platform, utilizes monoclonal antibodies to deliver vaccine directly to the patient’s immune system and focuses the immune system against hCG beta (hCG-β), a cancer-associated target believed to play a role in more aggressive forms of the disease. The data, presented at the 24th Annual Meeting of the International Society for Biological Therapy of Cancer (iSBTc) in Washington, D.C., demonstrated enhanced immunological and biological responses and support the planned initiation of Phase 2 clinical trials in hCG-β expressing cancers.

Genta Announces Top-Line Results of AGENDA Phase 3 Trial of Genasense® in Patients with Advanced Melanoma

Thu, 29 Oct 2009

BERKELEY HEIGHTS, NJ - October 29, 2009 - Genta Incorporated (OTCBB: GETA) today announced top-line results from AGENDA, the Company's Phase 3 trial of Genasense® (oblimersen sodium) Injection in patients with advanced melanoma. AGENDA is a randomized, double-blind, placebo-controlled trial of dacarbazine administered with or without Genasense® in patients who have not previously received chemotherapy. As defined in a prior randomized trial, AGENDA uses a biomarker to define patients who might maximally benefit from treatment.

AGENDA did not show a statistically significant benefit for its co-primary endpoint of progression-free survival. Secondary endpoints of overall response rate and disease control rate (which includes complete and partial responses, plus stable disease > 3 months duration) also did not show a statistically significant benefit. According to the prespecified analysis plan, the statistical significance of durable response - a secondary endpoint that measures the proportion of patients who achieved a complete or partial response that lasts > 6 months - is too early to evaluate. The observed differences in progression-free survival, overall response, disease control and durable response all numerically favored the group that received Genasense®.

BioCryst Reports Third Quarter 2009 Financial Results and Provides Corporate Update

Thu, 29 Oct 2009

BIRMINGHAM, Ala., Oct 29, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced financial results for the quarter and nine months ended September 30, 2009 and provided a corporate update regarding clinical programs and potential emergency use of intravenous (i.v.) peramivir.

"BioCryst has made significant progress in its efforts to enable the U.S. and other governments to acquire i.v. peramivir for use as a potential treatment option during this influenza emergency. The recent Emergency Use Authorization, or EUA, issued by the FDA, was an important milestone. BioCryst is prepared to provide peramivir if requested by the U.S. and other governments," said Jon P. Stonehouse, President and Chief Executive Officer of BioCryst Pharmaceuticals. "BioCryst remains committed to completing the U.S. development of peramivir through the traditional regulatory pathway."

Neurocrine Biosciences Reports Third Quarter 2009 Results

Thu, 29 Oct 2009

SAN DIEGO, Oct 28, 2009 /PRNewswire-FirstCall via COMTEX/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced its financial results for the quarter ended September 30, 2009. For the third quarter of 2009, the Company reported a net loss of $8.2 million, or $0.21 per share, compared with a net loss of $17.7 million, or $0.46 per share, for the same period in 2008. For the nine months ended September 30, 2009, the Company reported a net loss of $43.1 million, or $1.11 per share, as compared to $59.8 million, or $1.56 per share, for the same period last year.

CytRx Announces Publication of Paper Stating that Chaperone Amplification Represents a 'Significant Strategy' in Anti-aging Pharmaceutical Design

Wed, 28 Oct 2009

– Independent Review Links Diminished Chaperone Expression to Protein Damage in Aging Process –

– Expands Chaperone Regulation Technology’s Potential Applications and Enhances Partnering Opportunities –

LOS ANGELES--(BUSINESS WIRE)--Oct. 28, 2009-- CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical company and a leader in molecular chaperone regulation technology, today announced that a paper published in the peer-reviewed journal Gerontology concluded that molecular chaperone amplification may represent a “significant strategy” in the future design of anti-aging pharmaceuticals. The paper’s authors, led by Stuart K. Calderwood , Ph.D., of Beth Israel Deaconess Medical Center, Harvard Medical School, reviewed 40 clinical and animal studies in peer-reviewed publications and found that molecular chaperones play an important role in the deterrence of protein damage during the aging process and that chaperone expression is required for cell longevity.

StemCells, Inc. Announces $12.5 Million Equity Financing

Wed, 28 Oct 2009

PALO ALTO, Calif.--(BUSINESS WIRE)--Oct. 28, 2009-- StemCells, Inc. (NASDAQ:STEM) announced today that it has entered into an agreement to raise approximately $12.5 million in gross proceeds through the sale of approximately 10 million shares of its common stock to selected institutional investors at a price of $1.25 per share. The investors will also receive warrants to purchase approximately four million shares of common stock at an exercise price of $1.50 per share. The shares and warrants are being offered as a registered direct offering under the Company’s effective shelf registration statement previously filed with the Securities and Exchange Commission (SEC). StemCells, Inc. expects to receive total proceeds, net of offering expenses and placement agency fees, of approximately $11.9 million.

Dyax Corp. Announces Third Quarter 2009 Financial Results

Wed, 28 Oct 2009

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 28, 2009-- Dyax Corp. (NASDAQ: DYAX) today announced financial results for the third quarter ended September 30, 2009. Dyax will host a webcast and conference call at 10 a.m. (ET) this morning to review the financial results and corporate progress for the quarter.

MorphoSys AG Reports Results for the First Nine Months of 2009

Wed, 28 Oct 2009

MorphoSys AG (FSE: MOR; Prime Standard Segment; TecDAX) today announced its financial results for the nine months ending September 30, 2009 according to International Financial Reporting Standards (IFRS). Group revenues increased by 8 % to EUR 57.6 million (first nine months 2008: EUR 53.3 million) and operating profit was EUR 9.3 million (first nine months 2008: EUR 15.1 million). Net profit amounted to EUR 7.7 million (first nine months 2008: EUR 11.8 million). The main reason for the change in profits was, as planned, increased investment in proprietary drug development, amounting to EUR 11.9 million (first nine months 2008: EUR 3.6 million). MorphoSys's cash position on September 30, 2009 was EUR 139.8 million (December 31, 2008: EUR 137.9 million). The results are broadly in line with the Company's full year guidance.

Cardium Completes $6.0 Million Registered Direct Offering

Wed, 28 Oct 2009

SAN DIEGO, Oct. 20 /PRNewswire-FirstCall/ -- Cardium Therapeutics (NYSE Amex: CXM) today announced that it has completed its previously announced $6.0 million registered direct offering of common stock to selected investors. The transaction resulted in net proceeds to the company of $5.5 million after fees and expenses. The offering was made pursuant to a shelf registration statement that was filed by Cardium Therapeutics with the Securities and Exchange Commission (the "SEC") and declared effective by the SEC on August 15, 2007. Details concerning the terms of the financing and the warrants can be found in the Company's Current Report on Form 8-K filed with the SEC on October 15, 2009 at www.sec.gov.

Compugen Reports Third Quarter 2009 Financial Results

Tue, 27 Oct 2009

Tel Aviv, Israel, October 27, 2009 --- Compugen Ltd. (NASDAQ: CGEN) today reported financial results for the third quarter ended September 30, 2009.

Alnylam Grants KOKEN License to Kreutzer-Limmer Patents for the RNA Interference (RNAi) Research Products Market

Tue, 27 Oct 2009

CAMBRIDGE, Mass. & TOKYO--(BUSINESS WIRE)--Oct. 27, 2009-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, and KOKEN Co., Ltd., a leading atelocollagen company, announced today that Alnylam has granted KOKEN a non-exclusive worldwide license to manufacture and provide RNAi research products and services under the Kreutzer-Limmer patent family. This patent family, owned exclusively by Alnylam, covers fundamental aspects of the structure and uses of RNAi products, including small interfering RNAs (siRNAs) and their use to mediate RNAi in mammalian cells, and of RNAi-related mechanisms.