CeNeRx BioPharma Initiates Human Trials Of RIMA Antidepressant

Main Category: Depression
Also Included In: Bipolar;  Anxiety / Stress;  Clinical Trials / Drug Trials
Article Date: 31 Jan 2007 - 0:00 PDT

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CeNeRx BioPharma, Inc., a clinical stage company developing and commercializing innovative treatments for diseases of the central nervous system, today announced the initiation of human clinical trials of Tyrima(TM), CeNeRx's new drug candidate with a triple mechanism of action for the treatment of depression and anxiety. Tyrima (formerly CX157) is a member of a novel class of drugs known as reversible inhibitors of monoamine oxidase A, or RIMA. The Phase I safety trials began this month following a successful review of the Investigational New Drug (IND) application for Tyrima by the U.S. Food and Drug Administration.

"Initiation of human trials for Tyrima is an important milestone for CeNeRx, marking our transition to a clinical stage company," said Barry Brand, chief executive officer of CeNeRx. "Our third generation RIMA series of antidepressant compounds combine a known and effective triple action mechanism that is novel to the U.S., along with an improved safety profile that has been demonstrated in pre-clinical studies. The fact that a first generation RIMA antidepressant is already marketed in Europe significantly decreases the clinical risk associated with this approach, and we look forward to rapidly advancing Tyrima to Phase II trials after successful completion of these initial safety studies."

RIMA antidepressants elevate the levels of three key neurotransmitters that affect mood and anxiety (serotonin, norepinephrine and dopamine), in contrast to the leading antidepressants available today that affect the single neurotransmitter serotonin. This triple mechanism has the potential for enhanced efficacy and an improved therapeutic index compared to current therapies. Tyrima could be the first RIMA antidepressant available in the U.S. market, and it has patent protection through 2026. CeNeRx has worldwide rights to develop and commercialize Tyrima.

Alan Schatzberg, M.D., Kenneth T. Norris, Jr. professor and chairman, Department of Psychiatry and Behavioral Sciences at the Stanford University School of Medicine and a member of the CeNeRx scientific advisory board, noted, "Unlike other inhibitors of monoamine oxidase (MAOI), CeNeRx's RIMA agent Tyrima acts selectively and reversibly, thereby significantly reducing the cardiovascular risks historically associated with the MAOI approach. Tyrima therefore has the potential to be the first safe and well-tolerated oral antidepressant that works on all three key neurotransmitters known to play a role in mood disorders, offering the 30% of patients who currently do not receive adequate relief of their symptoms a safe option with the potential for enhanced efficacy."

The National Institute of Mental Health reports that major depressive disorders affect approximately 14.8 million American adults in a given year, or about 6.7 percent of the U.S. population aged 18 and older. Currently, major depressive disorder is the leading cause of disability in the U.S. for individuals aged 15-44. Many patients do not respond satisfactorily to current therapies, reinforcing the need for a range of safe and effective treatments.

CeNeRx has raised approximately $25 million to fund development of Tyrima and the RIMA antidepressant series. The company plans to enter Phase II trials later this year.

For more information about depression, please visit the National Institute of Mental Health (NIMH) web site at: http://www.nimh.nih.gov/healthinformation/depressionmenu.cfm.

About CeNeRx BioPharma

CeNeRx (SEN-er-ex) is a privately held clinical stage company developing and commercializing innovative and improved treatments for diseases of the central nervous system. The company focuses on identifying and developing promising therapeutics to treat diseases related to neurotransmitters, including anxiety, bipolar disorder, dementia, depression, epilepsy, neuropathic pain, schizophrenia, and Parkinson's and Alzheimer's diseases. CeNeRx's most advanced compounds, reversible inhibitors of monoamine oxidase, or RIMAs, are in Phase I and late pre-clinical development for the treatment of major depressive disorder. More information about CeNeRx BioPharma can be found at http://www.cenerx.com.

CeNeRx BioPharma, Inc.
http://www.cenerx.com

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