CeNeRx BioPharma Initiates Phase II Clinical Trial of Its Novel Antidepressant Agent ...( RESEARCH TRIANGLE PARK N.C. Oct. ...),Health

RESEARCH TRIANGLE PARK, N.C., Oct. 17 /PRNewswire/ -- 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 Tyrima(TM) 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.

The randomized, double-blind, placebo-controlled Phase II trial will enroll approximately 272 patients with moderate to severe MDD who will receive either Tyrima or placebo for six weeks. The primary study objective of antidepressant efficacy will be assessed using the Montgomery-Asberg Depression Rating Scale (MADRS). Secondary objectives of the study include evaluation of safety, tolerability, and pharmacokinetics of Tyrima. The trial design was supported by a Tyrima Phase I safety database of 106 subjects and a PET (positron emission tomography) study that yielded critical insight into the dose-response relationship of Tyrima. A number of patients are already randomized in the trial and initial results are expected by the end of 2009.

"Tyrima has the potential to be the first triple-action antidepressant with a safety profile appropriate for the treatment of a broad population of patients with depression, and we are committed to generating robust clinical data from this Phase Il trial," said Dr. Daniel Burch, Executive Vice President of R&D and Chief Medical Officer of CeNeRx. "We worked closely with experienced MDD clinical trial experts, disease specialists, and biostatisticia
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