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CeNeRx BioPharma Announces Successful Completion of Phase l Clinical Program for Novel Antidepressant Agent Tyrima(TM)
Date:1/16/2008

- Tyrima Exhibits Excellent Safety Profile and Favorable Pharmacokinetics

in Phase I Studies -

RESEARCH TRIANGLE PARK, N.C., Jan. 16 /PRNewswire/ -- CeNeRx BioPharma, Inc., a clinical stage company developing and commercializing innovative treatments for diseases of the central nervous system, today announced the successful completion of the Phase l clinical program for Tyrima(TM), its lead candidate for the treatment of depression and anxiety. Tyrima is a selective and reversible member of a novel class of drugs known as RIMAs, or reversible inhibitors of monoamine oxidase A. The Phase l program included acute dose, repeat dose and fed-fasted studies. The results of all studies were favorable, showing that Tyrima was safe and well tolerated and exhibited good pharmacokinetic properties.

"Tyrima has the potential to be the first triple-action antidepressant capable of treating a broad patient population, and we are very pleased with the safety and tolerability observed in the Phase l clinical program," said Dr. Daniel Burch, R&D head and chief medical officer of CeNeRx. "Monoamine oxidase A inhibitors (MAOI) have demonstrated efficacy advantages over conventional antidepressants, but their use has been limited by their potential for serious adverse food effects. In these Phase l studies, Tyrima demonstrated good safety and excellent drug-like properties, with a positive pharmacokinetic profile at all doses tested and minimal signs of fed-fasted effects. We look forward to initiating the Phase ll program in the second quarter of 2008."

Like conventional MAOI agents, the triple-action mechanism of Tyrima elevates the levels of three key neurotransmitters (serotonin, norepinephrine and dopamine) that positively affect mood and anxiety. In contrast, most of the current leading antidepressant drugs affect only the single neurotransmitter serotonin. However, unlike older MAOIs, the unique selectivity and reversibility
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SOURCE CeNeRx BioPharma, Inc.
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