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CeNeRx BioPharma Finalizes Plans to Initiate Phase II Trials for Its Novel Antidepressant Agent Tyrima(TM) Using Innovative Brain Imaging Study
Date:7/22/2008

- State-of-the-Art PET Study Confirms Tyrima Exhibits Excellent Drug-Like

Properties -

- Results Support Initiation of Phase II Clinical Trials -

RESEARCH TRIANGLE PARK, N.C., July 22 /PRNewswire/ -- 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 Tyrima(TM) 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).

"Tyrima has the potential to be the first triple-action antidepressant with a safety profile capable of treating a broad patient population, and we are very pleased with the promising properties Tyrima exhibited in these PET imaging studies," said Barry Brand, Chief Executive Officer of CeNeRx. "These encouraging results support our plans to initiate Phase II Tyrima trials in patients with major depression later this year."

"This innovative study used state-of-the-art PET imaging technology to demonstrate that Tyrima is penetrating and being eliminated from the brain in a consistent, predictable fashion," said Dr. Daniel Burch, Executive Vice President of R&D and Chief Medical Officer of CeNeRx. "Furthermore, the study has shown that plasma levels of Tyrima correlate extremely well with the action of Tyrima on MAO-A in the brain. This excellent pharmacokinetic/pharmacodynamic correlation has further increased our level of confidence in dose selection and the ability to demonstrate clinical efficacy as we move Tyrima into Phase
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SOURCE CeNeRx BioPharma
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