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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

id Dr. Daniel Burch, Executive Vice President of R&D and Chief Medical Officer of CeNeRx.  "CXB909's cognitive-enhancing effects are produced by a mechanism that is complementary to current cholinesterase inhibitors, suggesting that it could be developed as a stand-alone, add-on or combination therapy for the treatment of neurodegenerative disorders.  We look forward to advancing CXB909 in the clinic for its first indication as a potential treatment for chemotherapy-induced neuropathy."

In preclinical studies, CXB909 enhanced the action of NGF in vitro in biochemical and cellular assays, 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.   In two well-validated preclinical models, CXB909 concomitantly administered with the cancer drug taxane prevented nerve damage as measured by nerve conduction velocity, an objective parameter that is highly predictive of nerve function in humans.

"Our aging population is at risk for devastating neuropathic and neurodegenerative diseases that lack effective therapies, so we view the initiation of our clinical program for CXB909 as especially important," said Barry Brand, Chief Executive Officer of CeNeRx.  "We intend to assess CXB909 in a number of relevant conditions, beginning with chemotherapy-induced neuropathy, a disabling and dose-limiting side effect of cancer treatment that is an attractive commercial target 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 compounds to CeNeRx.  The lead compound in that program, TriRima™, is currently in a Phase ll t
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SOURCE CeNeRx BioPharma, Inc.
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