VistaGen Signs LOI with the National Institute of Mental Health

VistaGen Therapeutics Inc. (OTCQB:VSTA) announced that it has signed a letter of intent (LOI) to enter into a cooperative research and development agreement with the National Institute of Mental Health. The latter is part of the National Institutes of Health.

The parties will be collaborating on Phase 2 clinical study of VistaGen’s drug candidate, AV-101, in major depressive disorder.

As quoted in the press release:

The parties anticipate completing the definitive CRADA in December and both commencing and completing the Phase 2 depression study in 2015.

AV-101, an oral, non-sedating, non-hallucinogenic, NMDA receptor (NMDAR) glycineB-site antagonist, is among a new generation of fast-acting, glutamatergic antidepressants with breakthrough potential to treat millions of depression patients who are poorly served by classic antidepressant therapies. Published NIH placebo-controlled clinical trials provide compelling evidence that ketamine, a classic NMDAR channel blocker, produces rapid-onset antidepressant effects. However, the clinical utility of ketamine, which is administered intravenously, and other NMDAR channel blockers has been severely limited by their potential for abuse and dissociative side effects, including hallucinations and schizophrenia-like effects. By regulating the NMDAR rather than blocking it, AV-101 has the potential to achieve the rapid-onset antidepressant effects of ketamine and other classic NMDAR channel blockers, without causing their serious side effects.

Click here to read the full VistaGen Therapeutics Inc. (OTCQB:VSTA) press release.