VistaGen Therapeutics, Inc., a platform-enabled biopharmaceutical company applying embryonic stem cell technologies to discover, develop and commercialize small molecule drugs and protein therapeutics for diabetes and neurological disorders, announced today that it has been awarded $1.2 million in funding from the National Institutes of Health (NIH) to support final preparation and filing of the Company’s AV-101 Investigational New Drug application with the Food and Drug Administration in early 2008.
The award is the final phase of an aggregate of $4.3 million of grant support from the National Institute of Neurological Disorders and Stroke (NINDS), a division of the NIH, for preclinical development of AV-101. VistaGen expects to develop AV-101 for treatment of neuropathic pain, Parkinson’s disease and epilepsy.
“Success in securing and maintaining NINDS grant support for AV-101 signals that the NIH is impressed by the progress and quality of our development program, and encouraged by the therapeutic potential of AV-101,” said H. Ralph Snodgrass, Ph.D., VistaGen’s President and CEO. “Throughout our preclinical development of AV-101, we have consistently met all NIH milestones, and this latest phase of NIH funding means that we can now move rapidly towards AV-101 clinical trials”.
Aimed at the multi-billion dollar neurological disorders market, VistaGen’s AV-101 represents a potential “first-in-class” prodrug that regulates glutamate signaling by regulating the NMDA receptor. This targeted prodrug has the potential to reduce the severity of neuropathic pain, stimulate the firing of dopaminergic neurons (the neurons that die in Parkinson’s disease) and reduce the number and severity of epileptic seizures, while minimizing the neuronal death that often accompanies pathological neuronal signaling. Because AV-101 is a variant of a naturally occurring regulatory molecule found in the brain, it may also offer an improved side effects profile compared to existing neurological therapies.
