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
