VistaGen Therapeutics, Inc. (VSTA) Authorizes Letter of Intent with NIMH for NIH-Sponsored Phase 2 Study of AV-101 in Major Depressive Disorder

VistaGen signed a Letter of Intent to enter into a Cooperative Research and Development Agreement (CRADA) with the National Institute of Mental Health (NIMH), part of the National Institutes of Health (NIH), to collaborate on a NIMH-sponsored Phase 2 clinical study of VistaGen’s lead drug candidate, AV-101, in Major Depressive Disorder. The disorder is one of the most common in the U.S.

Both VistaGen and NIMH look to complete the CRADA next month 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 a new generation of fast-acting, glutamatergic antidepressants with potential to treat millions of depression patients who are ineffectively served by classic antidepressants. Published NIH placebo-controlled clinical trials show evidence that ketamine, a classic NMDAR channel blocker, produces rapid-onset antidepressant effects. However, intravenously administered clinical utility of ketamine and other NMDAR channel blockers has been badly limited by their potential for abuse and dissociative side effects. By regulating as opposed to blocking NMDAR, AV-101 potentially can achieve the rapid-onset antidepressant effects of ketamine and other classic NMDAR channel blockers – all without causing their serious side effects.

Dr. Carlos Zarate, Chief, Section on the Neurobiology and Treatment of Mood Disorders and Chief of the Experimental Therapeutics and Pathophysiology Branch at the NIH’s National Institute of Mental Health, is expected to be the Principal Investigator of the AV-101 Phase 2 depression study under the proposed Cooperative Research and Development Agreement.

VistaGen CEO, Shawn K. Singh noted, “Depression is a global public health concern, affecting over 350 million people worldwide, including millions in the U.S. We are pleased to be on a specific path headed toward extending our long-standing relationship with the NIH. Collaborating under the new CRADA will provide us and the NIMH with an important near term opportunity to make a major difference in the battle against depression.”

VistaGen is a clinical-stage biopharmaceutical company developing innovative medicine for depression, cancer and diseases and conditions involving the central nervous system. VistaGen’s lead drug candidate, AV-101, is a novel, potent, oral NMDAR glycineB-site antagonist entering Phase 2 clinical development focused on depression.

For additional information, visit the company’s website at www.vistagen.com

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