The grant is designed to help VistaGen progress its lead drug candidate AV-101 (4-Cl-KYN) through developmental trials.
VistaGen will 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. VistaGen anticipates submitting an application to the FDA in late 2006 to seek approval to carry out clinical tests on AV-101 for both epilepsy and neuropathic pain.
VistaGen expects to initiate phase I clinical development of AV-101 for epilepsy and neuropathic pain in early 2007.
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.