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VistaGen receives $3.7 million for epilepsy research

VistaGen Therapeutics has been awarded a grant of $3.7 million from the US National Institutes of Health to complete preclinical development of AV-101, its lead drug candidate for the treatment of epilepsy.

VistaGen claims AV-101 (4-Cl-KYN) represents a potential first-in-class therapy for the multi-billion dollar neuronal disorder markets, including major disorders such as epilepsy and neuropathic pain. The preclinical data produced as a result of this funding will support VistaGen in its application for FDA approval to commence clinical trials of the drug.

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.

Despite the numerous clinical limitations of current generation products, the annual global market for antiepileptic drugs exceeds $6.7 billion. Furthermore, 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 US alone, there are over 2.5 million epilepsy patients, with an estimated 200,000 new patients each year. Despite numerous drugs developed for epilepsy, significant underserved medical needs remain. According to VistaGen existing drugs do not adequately control the seizures of over 30% of adult epilepsy patients in the US and fail to provide therapeutic benefit to approximately 60% of children.