Burlingame, CA, May 24, 2005 /PRNewswire/ — 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) disorders and metabolic diseases using embryonic stem cell technologies, announced today that the National Institute of Neurologic Disorders and Stroke (NINDS), a division of the U.S. National Institutes of Health (NIH), has awarded the company a $3,700,000 grant entitled “Preclinical Development of 4-Cl-KYN to Treat Epilepsy.” This new NIH grant will enable VistaGen to complete preclinical development of AV-101 (4-Cl-KYN), its lead drug candidate, and support submission of an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration for clinical development of AV-101 for the treatment of epilepsy.
VistaGen’s AV-101 represents a potential first-in-class therapy multi-billion dollar neuronal disorder markets, including major disorders such as epilepsy and neuropathic pain. AV-101 is a novel prodrug that acts selectively on a regulatory site of the NMDA receptor and has shown anticonvulsant and neuroprotective activity in multiple models of epilepsy. Due to its unique mechanism of action and good oral delivery to the central nervous system, VistaGen believes AV-101 will deliver substantial value to the anti-epileptic drug marketplace through improved efficacy and decreased side-effects compared to drugs currently in use. In addition to epilepsy, VistaGen is evaluating AV-101 for treatment of neuropathic pain and Huntington’s disease.
“This major grant award for AV-101, our second from the NIH, will enable us to move rapidly towards clinical trials in epilepsy for this exciting new compound. Also, it will dramatically facilitate the clinical development of AV-101 in at least two other key neuronal disorders,” said H. Ralph Snodgrass, Ph.D., President and Chief Executive Officer of VistaGen. “The fact that our AV-101 grant application received a score in the top 7% of NINDS grant applications indicates that the independent panel of CNS experts chosen by the NIH was impressed by the data, AV-101′s potential, and our development plan.”
Despite the numerous clinical limitations of current generation products, the annual global market for antiepileptic drugs exceeds $6.7 billion. Independent market research reports estimate that the value of the anticonvulsant market is expected to increase by 95% to $13.1 billion by 2009. In the U.S. alone, there are over 2.5 million epilepsy patients, with an estimated 200,000 new patients each year. Despite numerous drugs developed for epilepsy, three significant underserved medical needs remain: (i) existing epilepsy drugs do not adequately control the seizures of over 750,000 (30%) of adult epilepsy patients in the US alone; (ii) existing epilepsy drugs do not provide therapeutic benefits to approximately 60% of children with seizures; and (iii) most existing epilepsy drugs cause significant unwanted side effects, including reduced cognitive function, toxicity, developmental effects, and sedation.
VistaGen Therapeutics is developing novel therapies for treatment of CNS disorders (epilepsy and neuropathic pain) and metabolic disease (diabetes), both of which are multi-billion dollar markets with major unmet medical needs. To expand its pipeline and generate revenue, VistaGen is applying its proprietary embryonic stem cell technology platform through strategic drug development collaborations with pharmaceutical companies. VistaGen’s stem cell-based drug discovery and development collaborations and internal research programs are expected to yield considerable efficiency gains compared to traditional animal-based techniques, resulting in faster, less-expensive, and more clinically relevant drug development programs. The potential for significant research funding from the State of California’s Institute of Regenerative Medicine resulting from California’s recently approved $3 billion Stem Cell Initiative is expected to dramatically benefit the stem cell technology companies in California, including VistaGen’s discovery, development and commercialization of stem cell-based products. VistaGen’s core strategic partnerships with Sanwa Kagaku Kenkyusho in diabetes drug development and with Cato Research Ltd., a leading contract research organization providing support in regulatory and clinical affairs, are important components of VistaGen’s corporate development strategy.
H. Ralph Snodgrass, Ph.D., President and CEO