|AVI BioPharma DSMB Reports No Safety Concerns Identified in Phase IIb DMD Clinical Trial, Recommends Continuation of Trial; Ironwood and Bionomics Announce Collaboration, Research, and License Agreement|
|By Staff and Wire Reports|
|Wednesday, 04 January 2012 19:44|
AVI BioPharma, Inc. (NASDAQ:AVII), a developer of RNA-based therapeutics, announced the independent Data Safety Monitoring Board (DSMB) providing oversight for AVI's Phase IIb study of eteplirsen in Duchenne Muscular Dystrophy (DMD) patients has reviewed the 12-week biopsy data from the highest dose cohort (50 mg/kg). Following its assessment of this biopsy data, along with other laboratory results and safety outcomes, the DSMB did not identify any safety concerns and determined it was safe to proceed with the trial as planned.
"This DSMB review is an important milestone for our Phase IIb study of eteplirsen in DMD patients," said Chris Garabedian, President and CEO of AVI. "The decision to proceed with the highest dose of eteplirsen beyond 12 weeks continues to support our belief in eteplirsen's favorable safety profile."
Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD) and Bionomics Limited (ASX: BNO) announced they entered into a collaboration, research, and licensing agreement that will enable Ironwood to develop and commercialize Bionomics investigational anti-anxiety compound BNC210 and other related compounds. The goal of the collaboration is to evaluate the compounds potential as a novel anti-anxiety treatment. Data from several preclinical studies indicate that BNC210 has anti-anxiety activity without the sedative side effects that are typical of benzodiazepines, a class of drugs used to treat anxiety. These data are further strengthened by Phase 1 clinical studies, where pharmacodynamic markers of anti-anxiety activity without sedation were observed in healthy volunteers who took a single dose of BNC210. This collaboration furthers both companies commitment to develop innovative treatments for patients with high unmet need.
Under the terms of the agreement, the companies will collaborate on initial research and Ironwood will be responsible for worldwide development and commercialization of all products incorporating BNC210 or other licensed compounds, including funding of clinical trials. Pending achievement of certain development and regulatory milestones, Bionomics could receive up to US$345 million in upfront and milestone payments and research funding, as well as royalties on sales of products incorporating BNC210 and other related compounds. Over the next 24 months, Bionomics may receive up to US$13 million in research funding and milestone payments, including an initial payment of US$3 million.
Aethlon Medical, Inc. (OTCBB: AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced today that its Chairman and CEO James A. Joyce will be the lead-off presenter at the Biotech Showcase™ 2012.
Alkermes plc (NASDAQ: ALKS) today announced positive topline results from a phase 1/2 study of ALKS 5461, a novel drug compound for major depressive disorder (MDD) in patients who have an inadequate response to standard therapies for clinical depression.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today the achievement of positive preliminary results from its ongoing clinical trial of ALN-PCS, an RNAi therapeutic targeting PCSK9 for the treatment of severe hypercholesterolemia.
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that Frank E. Thomas, chief operating officer and interim CEO, will provide an update on the Company followed by a breakout session at the 30th Annual J.P. Morgan Healthcare Conference on January 11 at 3:00 p.m., Pacific Time.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it will webcast its presentation at the 30th Annual J.P. Morgan Healthcare Conference in San Francisco.
Bio-Path Holdings, Inc. (OTC BB: BPTH) (“Bio-Path”), a biotechnology company developing a liposomal delivery technology for nucleic acid cancer drugs, today announced that Peter Nielsen, President and Chief Executive Officer, will present a company overview at the Biotech Showcase™ 2012 Conference in San Francisco, CA on Wednesday, January 11, 2012 at 3:30 p.m. Pacific Time.
Bristol-Myers Squibb Company (NYSE: BMY) will present at the 30th Annual J.P. Morgan Healthcare Conference on Tuesday, January 10, 2012, in San Francisco.
Cardium Therapeutics (NYSE Amex: CXM) today announced that it is scheduled to present at the Biotech Showcase 2012 and the 5th Annual OneMedForum Conference in San Francisco.
China Kanghui Holdings (NYSE: KH) ("Kanghui" or the "Company"), a leading domestic developer, manufacturer and marketer of orthopedic implants in China, today announced that the company will present at the 30th Annual J.P. Morgan Healthcare Conference on Wednesday, January 11, 2012 at 11:00 am Pacific Time at the Westin St. Francis Hotel in San Francisco.
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that in partnership with The New England Patriots Radio Network, 98.5 The Sports Hub, it has selected Sean Muller, a science teacher at Merrimack High School, in Merrimack, New Hampshire, to receive the Cubist Pharmaceuticals Science Education Leadership Award.
Dyax Corp. (NASDAQ: DYAX) announced today that it has entered into a loan agreement with an affiliate of Cowen Healthcare Royalty Partners (“Cowen Royalty”) through which it has received an initial loan of $20 million and a commitment to refinance its existing debt with Cowen Royalty at a reduced interest rate in August 2012.
Generex Biotechnology Corporation (OTCBB:GNBT) announced today that representatives of the Company's wholly-owned subsidiary, Antigen Express, Inc., will be in attendance at the 2012 JPMorgan Healthcare Conference in San Francisco from January 8 through 13.
Given Imaging (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced that approximately 700 patients have been enrolled in the Company's PillCam COLON 2 pivotal trial, and more than 500 patients have ingested PillCam COLON 2 in the trial.
Inovio Pharmaceuticals, Inc. (NYSE Amex: INO), which is revolutionizing vaccines to fight cancers and infectious diseases, announced today that it has promoted Niranjan Y. Sardesai, Ph.D., from Senior Vice President Research and Development to Chief Operating Officer.
InterMune, Inc. (NASDAQ: ITMN) today announced that it will report unaudited fourth quarter 2011 revenue related to sales of Esbriet® (pirfenidone) in Germany, as well as other metrics related to the Esbriet launch, prior to the open of the U.S. markets on Thursday, January 5, 2012.
InVivo Therapeutics Holdings Corp. (OTCBB: NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI), today announced CEO Frank Reynolds will present InVivo’s most recent breakthroughs and provide a business update to potential investors during the Fourth Annual BioTech Showcase.
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that Ron Bentsur, the Company's Chief Executive Officer, will be presenting at JP Morgan's 30th Annual Healthcare Conference, being held January 9th-12th in San Francisco, California.
Luminex Corporation (NASDAQ: LMNX) today announced that management will present at the 30th Annual JP Morgan Healthcare Conference to be held January 9 -12, 2012, in San Francisco, CA.
NeoStem, Inc. (NYSE Amex: NBS) ("NeoStem" or the "Company"), an international biopharmaceutical company with a focus on cell-based therapeutic development, today announced that the Company and Progenitor Cell Therapy ("PCT"), will be presenting at four upcoming January conferences: Biotech Showcase 2012, BOCEMb 2012 - Noble Financial Capital Markets Equity Conference, ECI's Inaugural Scale-Up and Manufacturing of Cell-Based Therapies, and Phacilitate's Cell & Gene Therapy Forum 2012.
OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that data evaluating its investigational compound custirsen (OGX-011/TV-1011) in patients with advanced non-small cell lung cancer (NSCLC) were published in an early online version of the January 2012 issue of the Journal of Thoracic Oncology.
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Company will present at The 30th Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Wednesday, January 11, 2012 at 4:30 p.m. PT (7:30 p.m. ET).
Seattle Genetics, Inc. (NASDAQ:SGEN) announced today that Clay B. Siegall, Ph.D., President and Chief Executive Officer, will present at the 30th Annual J.P. Morgan Healthcare Conference on Monday, January 9, 2012 at 10:30 a.m. Pacific Time.
Synergetics USA, Inc. (NASDAQ: SURG) announced that David M. Hable, President and Chief Executive Officer, will make a presentation at the Sidoti & Company Semi-Annual New York Micro Cap Conference on Monday, January 9, 2012.
Spectrum Pharmaceuticals (NasdaqGS:SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, announced today that an overview of the Company’s business strategy will be given at the 30th Annual J. P. Morgan Healthcare Conference, being held at the Westin St. Francis Hotel in San Francisco, California.
Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of vaccines in China, today announced the resignation of Ms. Chup Hung Mok from its Board of Directors for personal reasons.
Synergy Pharmaceuticals, Inc. (Nasdaq: SGYP, SGYPU, SGYPW), a developer of new drugs to treat gastrointestinal disorders and diseases, announced today the successful outcome of the Oral Hearing held December 14, 2011 before the Opposition Division of the European Patent Office regarding Synergy’s granted patent on plecanatide.
Telik, Inc. (Nasdaq: TELK) today announced that CEO Michael M. Wick, M.D., Ph.D. will provide a corporate update at the 5th Annual OneMedForum Conference on Wednesday, January 11 at 12:00 p.m. Pacific time (3:00 p.m. Eastern time) in San Francisco.
ThermoGenesis Corp. (NASDAQ: KOOL), a leading supplier of innovative products and services that process and store adult stem cells, said today that India's Ministry of Health has approved the AutoXpress® System (AXP), enabling the Company to initiate commercial sales of the product in India.
Vermillion, Inc. (NASDAQ:VRML), a molecular diagnostics company focusing on cancer and cardiology, announced a plan to streamline its organization and extend its cash runway.
XenoPort, Inc. (Nasdaq: XNPT) announced today that it will provide access via the World Wide Web to its presentation at the 30th Annual J.P. Morgan Healthcare Conference.