Anthera Pharmaceuticals, Inc., a privately held biopharmaceutical company developing anti-inflammatory drugs, announced today that after completing its review of safety and efficacy data from the first cohort of 30 patients, an independent Data Safety Monitoring Board (DSMB) has recommended that Anthera’s Phase II clinical trial, known as the IMPACTS (Investigation of the Modulation of Phospholipase in Acute ChesT Syndrome) Study can continue under the current protocol based on favorable interim results.
Anthera to continue impacts trial for the prevention of acute chest syndrome in patients with sickle cell disease
Cequent releases primate safety, efficacy data for oral FAP therapy
February 12, 2009
Cequent Pharmaceuticals this week unveiled non-human primate data demonstrating the safety and gene-silencing ability of its lead drug candidate, a treatment for familial adenomatous polyposis dubbed CEQ501, in what the company is calling the first proof of activity of an oral RNAi drug.
Cequent releases primate safety, efficacy data for oral FAP therapy
Cequent Pharmaceuticals this week unveiled non-human primate data demonstrating the safety and gene-silencing ability of its lead drug candidate, a treatment for familial adenomatous polyposis dubbed CEQ501, in what the company is calling the first proof of activity of an oral RNAi drug.
Plexxikon and Roche enter second partnership
Plexxikon Inc. and Roche (SWX:ROG), today announced that they have entered into an agreement to develop and commercialize a second novel kinase inhibitor, PLX5568. The main focus of this partnership will be the development of this small molecule inhibitor of Raf kinase as an oral therapeutic treatment for polycystic kidney disease (PKD). There is currently no registered treatment for PKD which affects over 600,000 patients in the U.S and is the most common life- threatening genetic disease.
CeNeRx BioPharma initiates Phase 2 clinical trial of its novel antidepressant agent Tyrima™
CeNeRx BioPharma, Inc., a clinical stage company developing and commercializing innovative treatments for diseases of the central nervous system, today announced that it has initiated a Phase II clinical trial for its lead product candidate TyrimaTM for the treatment of major depressive disorder (MDD). Tyrima is a selective and reversible member of a novel class of drugs known as RIMAs, or reversible inhibitors of monoamine oxidase A (MAO-A). The primary objective of this Phase II trial is to evaluate the antidepressant efficacy of Tyrima in patients with confirmed MDD. The trial design incorporates a number of features intended to reduce the variability and placebo response often observed in MDD clinical trials.
CeNeRx BioPharma completes $15 Million Series B financing
CeNeRx BioPharma, Inc., a clinical stage company developing and commercializing innovative treatments for diseases of the central nervous system (CNS), today announced completion of a $15 million Series B financing. Existing investors Aisling Capital, L Capital Partners and Pappas Ventures participated in the funding round. CeNeRx plans to use the proceeds to conduct a Phase II clinical trial of its lead product candidate TyrimaTM for the treatment of major depressive disorder (MDD), to further characterize its novel preclinical cannabinoid pipeline and potentially to acquire additional development stage compounds targeted at CNS disorders.
Anthera completes special protocol assessment with FDA and receives EMEA scientific advice on development path toward varespladib approval
Anthera Pharmaceuticals announced today they have reached agreement with the U.S. Food and Drug Administration (FDA) on a Phase 3 protocol for varespladib (A-002) in acute coronary syndrome (ACS) under the FDA’s Special Protocol Assessment procedure. At the same time, the company received Scientific Advice from the European Medicines Agency (EMEA) on Anthera’s European development strategy for varespladib. Guidance from both regulatory agencies regarding varespladib will be incorporated into Anthera’s global registration program slated to start next year.
Phase 2 Results of COL-144 Presented at European Headache and Migraine Trust International Congress 2008
LONDON, SEPT. 6, 2008 - CoLucid Pharmaceuticals, Inc., an innovative biotechnology company focusing on therapies for central nervous system disorders, announced Phase II results of its lead compound COL-144 in the treatment of acute migraine. Results demonstrated that COL-144 was safe and effective in relieving migraine headaches. COL-144 is a first-in-class Neurally Acting Anti-Migraine Agent (NAAMA), which unlike triptans, exhibits anti-migraine activity without causing vasoconstriction. COL-144 is a highly potent and selective 5HT1F receptor agonist. The studies were presented in poster presentations at the European Headache and Migraine Trust International Congress 2008 in London, Sept. 4-7, 2008.
CoLucid presents Phase 2 results of COL-144 at European Headache and Migraine Trust International Congress 2008
CoLucid Pharmaceuticals, Inc., an innovative biotechnology company focusing on therapies for central nervous system disorders, announced Phase II results of its lead compound COL-144 in the treatment of acute migraine. Results demonstrated that COL-144 was safe and effective in relieving migraine headaches. COL-144 is a first-in-class Neurally Acting Anti-Migraine Agent (NAAMA), which unlike triptans, exhibits anti-migraine activity without causing vasoconstriction. COL-144 is a highly potent and selective 5HT1F receptor agonist. The studies were presented in poster presentations at the European Headache and Migraine Trust International Congress 2008 in London, Sept. 4-7, 2008.
Plexxikon initiates Phase 1 Trial for PLX5568
BERKELEY, Calif., September 3, 2008--(Business Wire)--Plexxikon Inc. today announced that it has initiated a Phase 1 human clinical trial for PLX5568, a novel kinase inhibitor targeted for the treatment of at least two major indications with unmet medical needs: pain as well as polycystic kidney disease (PKD). PLX5568 has demonstrated robust preclinical efficacy in multiple pain models, including neuropathic pain as well as acute and inflammatory pain. In addition, PLX5568 has demonstrated compelling efficacy in multiple preclinical models of PKD.
