CeNeRx BioPharma Initiates Human Trials Of RIMA Antidepressant

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:
nimh.nih/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
cenerx.


CeNeRx BioPharma, Inc.

cenerx