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CeNeRx BioPharma Initiates Phase II Clinical Trial of Its Novel Antidepressant Agent Tyrima(TM)
Date:10/17/2008

ns to incorporate a number of features in the study design intended to manage the issues that can confound antidepressant clinical trial results."

Depression clinical trial expert Dr. Norman Rosenthal, Medical Director of Capital Clinical Associates and one of the lead investigators of the Tyrima Phase II study noted, "The CeNeRx team gets high marks for designing a first-class clinical trial. Recent efforts to test new antidepressants have encountered technical difficulties, such as a high placebo effect, which the current trial works hard to avoid. I am optimistic that the present trial should enable us to assess the potential of Tyrima as a potentially valuable new antidepressant agent."

Similar to the mechanism of conventional monoamine oxidase A inhibitors (MAOI), the triple-action mechanism of Tyrima elevates the levels of three key neurotransmitters (serotonin, norepinephrine and dopamine) that positively affect mood and anxiety, compared to the one or two neurotransmitters addressed by most current antidepressant drugs. This triple-action mechanism has the potential to provide improved antidepressant efficacy in some patients, while the selectivity and reversibility of Tyrima are expected to reduce or eliminate the risk of food-associated cardiovascular side effects of conventional MAOIs.

"A substantial subset of patients suffering from depression responds much better to treatment with MAOIs than other therapies, yet the risk of food-associated cardiovascular side effects of conventional MAOIs have greatly restricted their use, to the disadvantage of our patients," said Dr. Alexander Bodkin, a Tyrima Phase II investigator and Director of the Clinical Psychopharmacology Research Program at McLean Hospital of Harvard Medical School. "A novel agent such as Tyrima with proven MAOI activity in the CNS and a good safety and tolerability profile would be a valuable option for the many patients whose depression is refractory to treatment with cu
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SOURCE CeNeRx BioPharma, Inc.
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