VistaGen Therapeutics, Inc., a development stage biopharmaceutical company focused on discovering, developing and commercializing novel small molecule and protein therapeutics for Central Nervous System (CNS) and Peripheral Nervous System (PNS) disorders and metabolic diseases using embryonic stem cell technologies, announced today that the National Institute of Drug Abuse (NIDA), a division of the U.S. National Institutes of Health (NIH), has awarded the company a $197,000 grant entitled “Preclinical Development of 4-Cl-KYN to Treat Pain.” This new NIH grant, a Phase 1 Small Business Innovation Research (SBIR) grant, is the third for AV-101 (4-Cl-KYN), the Company’s lead drug candidate. The new NIH award will enable VistaGen to complete preclinical efficacy studies for AV-101 for use as a potential first-in-class therapeutic for treating pain caused by nerve damage associated with diabetes, viral infections, injuries, and cancer.
The NIH also recently awarded VistaGen a grant of $3,700,000 to complete all preclinical development for AV-101 for epilepsy. The nondilutive grant funding from the two recent NIH awards are expected to enable VistaGen to submit an FDA Investigational New Drug Application (IND) in late-2006 for clinical development of AV-101 for both epilepsy and neuropathic pain. VistaGen expects to initiate Phase 1 clinical development of AV-101 for epilepsy and neuropathic pain in early-2007.
“This grant award will enable us to further leverage our investments in developing drugs for neuronal diseases and move rapidly toward AV-101 clinical trials,” said H. Ralph Snodgrass, Ph.D., VistaGen’s President and Chief Executive Officer. “Our grant applications continue to be scored highly by the NIH’s external panel of CNS experts who are impressed with AV-101’s potential therapeutic benefits and novel mechanism of action, as well as with our drug development team’s ability to move drug candidates from the laboratory to the clinic in a timely fashion.”
Chronic neuropathic pain is a major disorder affecting millions of people worldwide with annual sales of prescription medications totaling more than $1 billion per year. Opiates are commonly prescribed widely for neuropathic pain, but are only partially effective, have unwanted side effects, and are prone to substance abuse that limits their use. By contrast, AV-101 is a prodrug with a unique method of action enabling it to penetrate the blood-brain barrier where it is converted selectively at the site of injury in the brain and spinal cord into one of the most potent and specific antagonists of the glycine site of the NMDA receptor. NMDA receptor signaling is thought to be an important mechanism involved in the neurological changes that lead to epilepsy and chronic neuropathic pain. In addition to a unique method of action, AV-101 is orally active (good bioavailability) and is expected to have fewer negative side effects than currently available therapies.
