VISTAGEN'S AV-101 DRUG CANDIDATE YIELDS POSITIVE
PRECLINICAL DATA FOR NEUROPATHIC PAIN APPLICATIONS
--IND TO BE SUBMITTED TO FDA IN 2007--
Burlingame, CA, January 30, 2007 --
VistaGen Therapeutics, Inc., an emerging biopharmaceutical company, focused
on stem cell technologies, to discover, develop and commercialize novel
small molecule drugs and protein therapeutics for neurological disorders
and diabetes, announced positive results from preclinical studies of
AV-101, its lead drug candidate, in acute and chronic neuropathic pain
animal models.
The preclinical studies suggest that AV-101, a first-in-class prodrug, has
the potential to treat pain caused by nerve damage associated with
diabetes, viral infections, injuries, and cancer.
"The results of these studies open another significant therapeutic
opportunity for our lead compound," said H. Ralph Snodgrass, Ph.D.,
VistaGen's President and Chief Executive Officer. "We believe AV-101's
ability to reduce and control seizures and chronic neuropathic pain is
similar to that of gabapentin (Pfizer's Neurontin®), the blockbuster drug
for epilepsy and neuropathic pain, and due to the lack of side effects, we
expect AV-101 to have a higher therapeutic index."
"In our preclinical studies, the relative analgesic dose effects and
side-effect profiles of AV-101 were comparable to those of gabapentin,"
said Tony L. Yaksh, Ph.D., Professor of Pharmacology, School of Medicine,
Department of Anesthesiology, University of California, San Diego, and a
collaborator with VistaGen on this project. "It was notable that AV-101 had
no sedative or motor effects even at the highest doses," added Dr. Yaksh.
The studies were supported by the National Institute of Drug Abuse, a
division of the U.S. National Institutes of Health (NIH). The NIH has
continued to support VistaGen with over $4 million of nondilutive grant
funding for preclinical development of AV-101. VistaGen expects to submit
an Investigational New Drug Application, or IND, to the FDA in 2007 and
begin clinical development of AV-101 for epilepsy and neuropathic pain in
2008.
Chronic neuropathic pain is a major disorder affecting millions of people
worldwide. The neuropathic market is projected to be greater than $4
billion in 2007. 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.
AV-101 is orally active and is expected to have fewer negative side effects
than currently available therapies.
About VistaGen Therapeutics
VistaGen Therapeutics, Inc. is a platform-enabled biopharmaceutical company
pioneering the use of embryonic stem cells ("ES Cells") as proprietary
biological systems for drug discovery and development. VistaGen's core
technology is an ES Cell-based R&D platform that could offer a renewable
source of breakthrough drug therapies for a wide variety of diseases,
including cardiovascular disease, diabetes and multiple neurological
disorders such as Parkinson's disease. VistaGen's customized ES Cell-based
biological assays and screening systems help discover, validate, and
prioritize novel drug targets, as well as identify the biological function
and potential therapeutic utility of new drug candidates with greater
flexibility, speed and efficiency compared to traditional techniques
currently used in the pharmaceutical industry.
For further information, contact:
H. Ralph Snodgrass, Ph.D., President and CEO
650-558-9505 (v)
rsnodgrass@vistagen-inc.com
www.vistagen-inc.com