How do you develop drugs for diseases that you can’t see until it’s too late? Where the cause is buried in parts of the body that defy most experimental methods? Where biomarkers don’t exist?
Getting Closer to Nature: The BrainCells Way
Dynogen reports positive results in Phase 2 IBS-c study
Dynogen Pharmaceuticals, Inc. today reported positive results of its randomized, double-blind, placebo–controlled, parallel group Phase 2 trial of DDP733 in patients with irritable bowel syndrome with constipation (IBS-c). DDP733 achieved an overall clinical response rate of 54% in patients receiving a dose of 1.4 mg t.i.d. compared to a 15% clinical response rate for patients receiving placebo. This was a statistically significant difference in a clinical endpoint which has been accepted by the FDA as a registration endpoint for this indication. The drug was well tolerated in this study. Detailed results will be submitted for disclosure in a peer-reviewed journal or at a future medical conference.
CeNeRx BioPharma initiates human trials of RIMA antidepressant
CeNeRx BioPharma, Inc., a clinical stage company developing and commercializing innovative treatments for diseases of the central nervous system, today announced the initiation of human clinical trials of TyrimaTM, CeNeRx’ s new drug candidate with a triple mechanism of action for the treatment of depression and anxiety. Tyrima (formerly CX157) is a member of a novel class of drugs known as reversible inhibitors of monoamine oxidase A, or RIMA. The Phase I safety trials began this month following a successful review of the Investigational New Drug (IND) application for Tyrima by the U.S. Food and Drug Administration.
FlowCardia, Inc. announces 510(k) clearance for its chronic total occlusion recanalization system
FlowCardia, Inc., a medical device company developing endovascular devices for coronary and peripheral chronic total occlusion (CTO) recanalization, announcedFDA 510(k)clearance of the CROSSER(TM) 14 CTO Recanalization System. The CROSSER 14 is designed to facilitate the placement of guidewires beyond CTOs in coronary arteries.
Biogen Idec to acquire Syntonix Pharmaceuticals
Biogen Idec (NASDAQ:BIIB) and Syntonix Pharmaceuticals today announced that the companies have signed a definitive agreement for the acquisition of Syntonix by Biogen Idec. Syntonix, a privately held biopharmaceutical company focused on discovering and developing long-acting therapeutic products to improve treatment regimens for chronic diseases, has multiple pre-clinical programs in hemophilia.
Cerexa to be acquired by Forest Laboratories for $480 million plus potential $100 million milestone payment
Cerexa Inc. today announced it has entered into a definitive agreement to be acquired by Forest Laboratories Inc. (NYSE: FRX) for $480 million plus a potential $100 million milestone payment.
TargeGen initiates Phase I clinical trial of topical AMD drug TG100801
TargeGen, Inc. has announced that the Company has initiated a single site Phase I clinical trial involving TG100801, a small molecule, topically applied multi-targeted kinase inhibitor for the treatment of macular degeneration and other debilitating diseases of the eye. Macular degeneration is the leading cause of blindness in adults. The trial, involving approximately 45 subjects, is expected to be completed by the end of the first quarter of 2007. The Company hopes to initiate Phase II studies with TG100801 in mid 2007.
Cerexa expands portfolio of novel anti-infective therapies through in-licensing agreement with Meiji Seika Kaisha
Cerexa Inc. today announced it has expanded its portfolio of novel anti-infective therapies through an in-licensing agreement with Meiji Seika Kaisha Ltd.
BrainCells and Organon to collaborate in discovery and development of CNS drugs
BrainCells Inc. (BCI) and Organon, the human health care business unit of Akzo Nobel (Nasdaq: AKZOY), today announced they will collaborate in the discovery and development of drugs for the treatment of central nervous system (CNS) disorders.
Anthera Pharmaceuticals secures $36m venture financing to initiate clinical programs
Anthera Pharmaceuticals, a specialty pharmaceutical company developing therapies for the treatment of serious inflammatory diseases, today announced it closed an initial $36 million in venture financing. The funding was co-led by VantagePoint Venture Partners and Sofinnova Ventures and are joined by Pappas Ventures, Mitsubishi International Corporation, along with Series A-1 investors Sears Capital Management and SIM Equity. Eli Lilly and Company and Shionogi & Co., Ltd. also received equity as part of Anthera’s obligations under the recently announced license agreement. Annette Bianchi, Managing Director, and co-Head of VantagePoint’s Healthcare Practice Group and Jim Healy, General Partner of Sofinnova Ventures were named to the Board of Directors.
