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CeNeRx BioPharma, Inc.'s Novel Antidepressant TriRima(TM) Demonstrates Key Safety Benefit in Pivotal Safety Study


11/2/2010 10:55:59 AM

RESEARCH TRIANGLE PARK, N.C., Nov. 2, 2010 /PRNewswire/ -- CeNeRx BioPharma, Inc., today announced that a new formulation of TriRima, its lead agent for treatment resistant depression, showed excellent safety in a study designed to test whether it is free of the food-induced cardiovascular effects associated with conventional MAO inhibitors. These positive results further confirm the good safety profile demonstrated by TriRima in Phase I studies and set the stage for a TriRima Phase II clinical trial as monotherapy in treatment resistant depression, scheduled to begin later this month.

TriRima is a member of a novel class of drugs known as RIMAs, or reversible and selective inhibitors of monoamine oxidase A (MAO-A). MAO inhibitors achieve superior "triple-action" antidepressant efficacy by elevating the levels of all three of the key neurotransmitters that positively affect mood. However, older MAO inhibitors were limited by their potential for causing serious cardiovascular side effects when foods containing the naturally occurring substance tyramine were consumed. TriRima is designed to achieve the efficacy of the MAO inhibitor class while reducing or eliminating the risk of these food-associated effects. In the "tyramine challenge" study reported today, subjects receiving a modified release formulation of TriRima showed no signs of any negative effects, even after receiving large amounts of tyramine.

"This new formulation of TriRima performed extremely well in the tyramine safety study," said Daniel Burch, MD, Chief Medical Officer of CeNeRx. "It achieved plasma levels 10-fold higher than our original formulation and drug exposure two to three times greater than the version used in our initial efficacy studies, yet we did not observe any sign of cardiovascular effects, even in the presence of high doses of tyramine administered during peak TriRima exposure. This excellent safety profile could enable TriRima to become the first agent to achieve the triple action efficacy of MAO inhibitor drugs without their limiting side effects."

The modified release formulation of TriRima has major advantages over the version used in earlier studies. In addition to the excellent pharmacokinetic properties noted above, the dosing frequency has been reduced to one tablet two times daily.

"Just as the greater safety of the selective serotonin reuptake inhibitors once enabled millions of patients to benefit from their antidepressant potential, we believe that TriRima could unlock the superior antidepressant potential of the MAO inhibitor class," said Barry Brand, Chief Executive Officer of CeNeRx. "TriRima has the potential to be the first monotherapy approved for treatment resistant depression, and we look forward to initiating a Phase II trial in these patients before the end of the month."

TriRima has been selected as one of Windhover's 2011 "Top 10 Neuroscience Projects to Watch," and CeNeRx has been chosen to present at Windhover's Therapeutic Area Partnerships meeting, which will be held November 2-4, 2010 at the Westin Copley Place in Boston, MA. CeNeRx will present at 4:30 PM on November 2 and at 11:15 AM on November 3, 2010. More information on the meeting can be found at www.tapartnerships.com.

About CeNeRx BioPharma

CeNeRx is a privately held clinical-stage biopharmaceutical company developing and commercializing innovative treatments for diseases of the central nervous system. CeNeRx's most advanced compound, a reversible inhibitor of monoamine oxidase, or RIMA, is in Phase II development for treatment resistant depression. RIMAs may have efficacy advantages over current agents for depression and are expected to have a good safety profile. The company's CNS pipeline also includes clinical-stage hypothalamic-pituitary adrenal (HPA) axis modulators for the treatment of a variety of CNS disorders including anxiety and depression; a small molecule, orally active agent for the prevention and treatment of neuropathies and neurodegenerative disorders; and a series of selective cannabinoid compounds that have recently completed successful preclinical proof-of-concept studies for the treatment of pain, glaucoma and spasticity. More information can be found at www.cenerx.com.

Contact:

GendeLLindheim BioCom Partners

Barbara Lindheim

212 918 4650



SOURCE CeNeRx BioPharma, Inc.


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