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CeNeRx BioPharma Obtains Rights to Novel Drug Candidate for Prevention and Treatment of Neurodegeneration Disorders
Date:6/16/2009

--Orally Active Enhancer of Human Nerve Growth Factor Has Demonstrated Promising Activity Preclinically--

--Broad Potential Applications Include Neuropathies, Alzheimer's and Huntington's Disease and Others--

RESEARCH TRIANGLE PARK, N.C., June 16 /PRNewswire/ -- CeNeRx BioPharma, Inc., a clinical stage company developing and commercializing innovative treatments for diseases of the central nervous system (CNS), today announced that it has obtained the rights to develop and market a novel agent for the prevention and treatment of neuropathies and neurodegenerative disorders. The drug candidate, CXB909, is a small molecule, orally active agent that enhances the effects of nerve growth factor (NGF). CeNeRx intends to initiate a Phase l trial of CXB909 for the treatment of chemotherapy-induced peripheral neuropathy (CIPN) later this year.

"Nerve growth factor has long been of interest as a potential therapy for neuropathies and neurodegenerative diseases, but recombinant NGF lacks key qualities needed for successful CNS drugs," said Dr. Daniel Burch, Executive Vice President of R&D and Chief Medical Officer of CeNeRx. "In preclinical studies, our small molecule agent CXB909 has been shown to increase the action of native NGF, but without the pharmacokinetic and administration challenges of recombinant NGF. Most notably, CXB909 crosses the blood brain barrier, has a long half-life and is orally available. The preclinical data for this agent is very promising, and we look forward to assessing it in the clinic for neuropathic and neurodegenerative conditions that currently have no treatment options."

CXB909 is a downstream enhancer of the effects of nerve growth factor, an endogenously produced neurotrophic factor that is important for the function and survival of several types of neurons. Both Alzheimer's disease and Huntington's disease involve the degeneration of certain neurons, and neuronal damage is also implicated in the peripheral neuropathies associated with diabetes, kidney disease, cancer chemotherapy and other conditions. In preclinical studies, CXB909 enhanced the action of NGF in vitro, amplifying its activity almost seven-fold. CXB909 was neuroprotective in a variety of cellular assays and in animal models of neuropathies and neurodegenerative diseases, including chemotherapy-induced neuropathy, for which there is currently no approved treatment.

"The addition of CXB909 to our development pipeline is another example of the growing success of our strategy to in-license novel CNS agents with validated mechanisms for the treatment of underserved CNS disorders," said Barry Brand, Chief Executive Officer of CeNeRx. "Our rapidly aging population is at risk for devastating neuropathic and neurodegenerative diseases that lack effective therapies. We intend to move quickly to test CXB909 in relevant conditions, beginning with chemotherapy-induced peripheral neuropathy, a disabling and dose-limiting side effect of cancer treatment with a relatively straightforward pathway to clinical development and regulatory review."

CXB909 was licensed from Krenitsky Pharmaceuticals Inc., which also licensed the RIMA series of selective and reversible monoamine oxidase inhibitor (MAOI) compounds to CeNeRx. The lead compound in that program, TriRima(TM), is currently in a Phase II trial for the treatment of major depressive disorder. Further details of the new licensing agreement were not disclosed.

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 the treatment of major depressive disorder. 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 CXB909, a small molecule, orally active agent for the prevention and treatment of neuropathies and neurodegenerative disorders; a series of novel compounds for anxiety and depression; 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 about CeNeRx BioPharma can be found at www.cenerx.com.

    Contact:
    GendeLLindheim BioCom Partners
    Barbara Lindheim
    212 918 4650


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SOURCE CeNeRx BioPharma, Inc.
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