CeNeRx BioPharma Successfully Completes Clinical Program For Novel Antidepressant Agent Tyrima

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CeNeRx BioPharma announced successful completion of the Phase l clinical program for Tyrima, 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."

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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 of CeNeRx's Tyrima should enable patients to benefit from the efficacy advantages of the class while avoiding the food-associated cardiovascular side effects of older MAOIs. The potential for these adverse effects has greatly restricted the use of conventional MAOI agents.

The Phase l program evaluated a range of Tyrima doses in 65 subjects. The repeat dose study results confirmed the positive findings of the acute dose trial that were reported previously. Tyrima was well tolerated, with no clinically significant adverse events reported at any dose. It achieved high plasma concentrations and exhibited a favorable pharmacokinetic half-life consistent with once- or twice-daily dosing.

"Successful completion of the Phase l program is a major milestone for our third-generation RIMA agents, whose triple-action mechanism has the potential to provide greater antidepressant efficacy to the many patients who do not obtain adequate relief from currently available therapies," said Barry Brand, chief executive officer of CeNeRx. "Tyrima offers a mechanism of action that is well-precedented and it has novel safety advantages. We look forward to rapidly advancing the Phase ll program."

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