|France Becomes 17th Country to Clear Cel-Sci for Phase 3 Cancer Trial; Regeneron and Sanofi Announce Plan For Alirocumab U.S. FDA Submission|
|By Staff and Wire Reports|
|Wednesday, 30 July 2014 19:42|
CEL-SCI Corporation (NYSE MKT: CVM) today announced that the French Agency for the Safety of Health Products has cleared the Company to commence patient enrollment for its Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection) in France. In the past three months CEL-SCI has also received governmental clearance to expand its trial into the United Kingdom, Austria, Sri Lanka and Turkey.
CEL-SCI’s Phase III trial is assessing the Company’s investigational immunotherapeutic agent Multikine as a potential first-line treatment for advanced primary head and neck cancer. The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer. The objective of the study is to demonstrate a statistically significant improvement in overall survival of enrolled patients who are treated with the Multikine treatment regimen plus Standard of Care (SOC) vs. subjects who are treated with SOC only.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi (EURONEXT: SAN and NYSE: SNY) today announced that the Companies intend to use a U.S. Food and Drug Administration (FDA) rare pediatric disease priority review voucher in connection with the Biologics License Application (BLA) submission for alirocumab. The priority review voucher entitles the holder to designate a BLA for priority review, which provides for an expedited 6-month review from the filing date instead of the standard 10-month review.
Regeneron Ireland, an indirect, wholly-owned subsidiary of Regeneron Pharmaceuticals, Inc., purchased the voucher from BioMarin GALNS Ltd., a direct, wholly-owned subsidiary of BioMarin Pharmaceutical, Inc., which had received it through the FDA's Rare Pediatric Disease Priority Review Voucher Program. Sanofi and Regeneron will equally share the purchase price of $67.5 million.
"The priority review voucher program was established to provide incentives that would enhance innovation in key areas of unmet patient need," said Ned Braunstein, M.D., Vice President, Regulatory Affairs at Regeneron. "Our decision to acquire and leverage the voucher is clear evidence that this program is a valuable incentive for biopharmaceutical companies."
Sanofi and Regeneron expect to submit U.S. and EU regulatory submissions for alirocumab before year end. Alirocumab is an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) that is being evaluated for its potential to lower low-density lipoprotein cholesterol (LDL-C) in patients who are not at their current LDL-C target with standard lipid-modifying therapies.
The Pediatric PRV was created by the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) and is intended to encourage the development of treatments for rare pediatric diseases. Companies that receive a voucher may use it or transfer the voucher, including by sale, to other organizations.
Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to endoplasmic reticulum stress, cell cycle dysregulation, neurodegeneration and apoptosis, today announced that it has amended the clinical protocol for its LP-002 Alzheimer's disease bridging diagnostic study of LymPro in order to perform an interim analysis of 44 subjects recruited from a single clinical site, from an originally planned 72 subjects across 4 clinical sites.
Celldex Therapeutics, Inc. (Nasdaq:CLDX) today announced three promotions in the Company's clinical and research departments: Tibor Keler, PhD promoted to Executive Vice President and Chief Scientific Officer; Thomas Davis, MD promoted to Executive Vice President and Chief Medical Officer; and Elizabeth Crowley promoted to Senior Vice President, Product Development.
CombiMatrix Corporation (Nasdaq:CBMX) announced today that it will release its second quarter 2014 financial results on Wednesday, August 6, 2014. Results will be released after the close of trading on that day.
Dehaier Medical Systems Ltd. (Nasdaq:DHRM), an emerging leader in the development, assembly, marketing and sale of medical devices and sleep respiratory products in China, today announced the results of its 2014 annual general meeting of shareholders.
Egalet Corporation (Nasdaq:EGLT) today announced that Bob Radie, president and chief executive officer, is scheduled to present at the Canaccord Genuity Growth Conference on Wednesday, August 13, 2014, at 4:00 p.m. EDT.
Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, today announced financial results for the three and six months ended June 30, 2014.
Galectin Therapeutics (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announced yesterday results of cohort 2 of its phase 1 clinical trial in patients with NASH with advanced fibrosis.
Gevo, Inc. (Nasdaq:GEVO), a leading renewable chemicals and next-generation biofuels company, announced today that it intends to offer and sell, subject to market and other conditions, common stock units. Each common stock unit will consist of one share of common stock and a warrant to purchase a certain number of shares of common stock.
MedAssets, Inc. (Nasdaq:MDAS) today announced results for its second quarter and six-month period ended June 30, 2014.
Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that its presentation at the Canaccord Genuity Growth Conference will be webcast on Thursday, August 14 at 4:00 p.m. ET.
Novavax, Inc. (Nasdaq:NVAX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, announced today that it will report its financial results for the second quarter of 2014 on Wednesday, August 6, 2014, after market close.
Radius Health, Inc. (Nasdaq:RDUS), a science-driven biopharmaceutical company developing novel differentiated therapeutics for patients with advanced osteoporosis as well as other serious endocrine-mediated diseases, will visit the NASDAQ MarketSite in Times Square.
Steiner Leisure Limited (Nasdaq:STNR) today announced financial results for the second quarter ended June 30, 2014.
Tauriga Sciences, Inc. (OTCQB:TAUG), a diversified life sciences company, today announced it received notice of approval effective as of July 29, 2014 from OTC Markets Group, Inc. to continue trading on the OTCQB Marketplace.
Vascular Solutions, Inc. (Nasdaq:VASC) today announced that the Company is scheduled to present at the 34th Annual Canaccord Genuity Growth Conference in Boston on Thursday, August 14th at 2:00pm (EDT).
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of antibody therapeutics, announced the Company will host a conference call on Thursday, August 7, 2014, at 4:30 p.m. Eastern Daylight Time to discuss second quarter 2014 financial results and provide an update on gevokizumab's global clinical programs.