VistaGen Therapeutics, Inc., a development stage biopharmaceutical company focused on discovering, developing and commercializing novel small molecule and protein therapeutics using embryonic stem cell technologies, announced today that the High Q Foundation, Inc. has agreed to support VistaGen’s preclinical efficacy studies of AV-101 for the treatment of Huntington’s disease (HD). VistaGen and its scientific advisors have observed that AV-101, VistaGen’s lead drug candidate for epilepsy and neuropathic pain, can reduce the production of quinolinic acid, a neurotoxin produced in the brain and believed to be involved in the pathology of HD.
“High Q’s support will allow us to study further the utility of AV-101 for treating the cognitive and motor decline associated with a variety of neurological degenerative diseases, and potentially to add a third large indication for AV-101 as we move rapidly towards clinical trials,” said H. Ralph Snodgrass, Ph.D., VistaGen’s President and Chief Executive Officer. “High Q’s support, in addition to the support we have received from the NIH and others, reinforces our belief that AV-101 has potentially broad clinical applications in the neurodegenerative area.”
“We are pleased to support VistaGen’s studies of AV-101 in models of Huntington’s disease. Their approach may lead to a new therapeutic opportunity for this devastating disease,” said Allan Tobin, Ph.D., Senior Scientific Advisor of the High Q Foundation.
HD is a slowly progressing neurodegenerative disease, which affects approximately 1 in 10,000 people in most “western” countries. There is currently no effective therapy to slow the rate of progression of the neurological decline associated with the disease. One of the metabolic products of AV-101 is a very potent inhibitor of an enzyme that is responsible for the production of quinolinic acid, a neurotoxin produced at increased levels in the brains of patients and animal models of HD. VistaGen is collaborating with Robert Schwarcz, PhD, a professor of psychiatry, pharmacology and pediatrics at the University of Maryland School of Medicine in Baltimore, to evaluate the therapeutic potential of AV-101 in animal models of HD. “We hope that blocking this critical enzyme will reduce the formation of quinolinic acid in the brain and will therefore slow or even prevent the neurodegeneration associated with HD,” said Dr. Schwarcz.
The U.S. National Institutes of Health (NIH) recently awarded VistaGen two grants totaling almost $4 million to complete preclinical development of AV-101 for epilepsy and to support preclinical efficacy studies of AV-101 for neuropathic pain. The nondilutive grant funding from these recent NIH awards are expected to enable VistaGen to submit an Investigational New Drug Application (IND) to the Food & Drug Administration (FDA) in late-2006 for clinical development of AV-101 for epilepsy and neuropathic pain. VistaGen expects to begin Phase I clinical development of AV-101 in early-2007.