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CeNeRx Announces FDA IND Approval for its Neuroprotective Agent in Chemotherapy-Induced Neuropathy and Results From First Human Study
Date:2/9/2011

RESEARCH TRIANGLE PARK, N.C., Feb. 9, 2011 /PRNewswire/ -- CeNeRx BioPharma, Inc., a clinical-stage company developing and commercializing innovative treatments for diseases of the central nervous system (CNS), today announced FDA approval of its IND and reported the first clinical results in humans for CXB909, a novel agent that has demonstrated utility in preclinical models of neuroprotection and neurodegenerative disorders.  CXB909 is a small molecule, orally active agent that enhances the effects of nerve growth factor (NGF) and is also believed to promote synthesis of acetylcholine.  CeNeRx is now preparing to launch further Phase I studies of CXB909 targeting chemotherapy-induced peripheral neuropathy as its first potential indication.  

CXB909 appears to enhance cholinergic tone and is a downstream enhancer of the effects of NGF, a naturally occurring neurotrophic factor that is important for the function and survival of several types of neurons.  NGF may help prevent or reverse the neuronal damage that is implicated in the peripheral neuropathies associated with cancer chemotherapy, diabetes, kidney disease, and other conditions. The degeneration of certain neurons associated with Alzheimer's disease and Huntington's disease may also be ameliorated by increased levels of NGF.  

Past attempts to use recombinant versions of NGF to prevent and treat neuron-damaging conditions were stymied by its lack of drug-like properties.  In contrast, CXB909 crosses the blood-brain barrier, has a long half-life and is orally available.  Results from an initial Phase I study in 26 subjects showed that single doses of CXB909 administered orally resulted in good levels of drug exposure and were well-tolerated.

"CXB909 has been shown to increase the action of endogenous NGF and enhance cognition and neuroprotection in multiple preclinical models, and it has demonstrated good safety in animal and early human studies," sa
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SOURCE CeNeRx BioPharma, Inc.
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