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 initiates Phase 2 clinical trial of its novel antidepressant agent Tyrima™
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.
Plexxikon initiates Phase 1 Trial for PLX5568
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.
Anthera advances global development strategy for varespladib with the initiation of FRANCIS trial
Anthera Pharmaceuticals Inc., a privately held biopharmaceutical company developing anti-inflammatory drugs, today announced the initiation of the FRANCIS (Fewer Recurrent Acute coronary events with Near-term Cardiovascular Inflammation Suppression) clinical trial designed to examine the impact of varespladib when administered to patients within 96 hours of an Acute Coronary Syndrome (ACS) event.
CeNeRx BioPharma to initiate Phase 2 trials for its novel antidepressant agent Tyrima™ using innovative brain imaging study
CeNeRx BioPharma, Inc., a clinical stage company developing and commercializing innovative treatments for diseases of the central nervous system, today announced plans to advance its lead candidate TyrimaTM into Phase II trials for the treatment of depression and anxiety. This milestone is based on the positive results of the Tyrima Phase I program reported earlier this year and the recent completion of PET brain imaging studies showing that Tyrima penetrates the CNS and exhibits excellent pharmacokinetic and pharmacodynamic properties. 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).
CoLucid announces $25 million Series B financing for advancement of first-in-class migraine compound
CoLucid Pharmaceuticals, Inc., an innovative biotechnology company focusing on therapies for central nervous system disorders, announced it closed a $25 million Series B financing. New investor Care Capital led the round, which included previous investors Pappas Ventures, Domain Associates, Pearl Street Venture Funds and Triathlon Medical Ventures. The financing will be used to further develop a unique migraine compound, COL-144, and to advance a preclinical pipeline of novel chemical entities targeting neurological and psychiatric disorders.
