VistaGen Therapeutics, a clinical-stage biopharmaceutical company
developing innovative medicine for depression and conditions involving the
central nervous system, has expanded its Clinical and Scientific Advisory Board
with the addition of Gerard Sanacora PhD, MD, professor of psychiatry at the
Yale School of Medicine and director of the Yale Depression Research Program.
“Dr. Sanacora and his colleagues at Yale Depression Research Program
are among the global leaders in the discovery and elucidation of ketamine’s
mechanism of action in depression,” Shawn Singh, CEO of VistaGen, stated in the
news release. “His extensive research and recent clinical experience with the
use of ketamine for treating [major depressive disorder] will be highly
valuable as we advance AV-101 into late-stage development for depression and
other [central nervous system] indications.”
Dr. Sanacora will focus on phase 2 and phase 3 clinical development of
AV-101, VistaGen’s orally active NMDA receptor modulator for treating major
depressive disorder (MDD). AV-101 is a unique prodrug candidate that produces,
in the brain, 7-chlorokynurenic acid (7 Cl KYNA), one of the most potent and
selective antagonists of the required glycine-binding site of the NMDA
receptor, which results in down-regulation of NMDA signaling.
Previous MDD clinical studies of ketamine conducted by the NIH, Yale
and others demonstrated rapid relief of depressive symptoms in
treatment-resistant MDD patients, providing compelling clinical evidence of the
key role of NMDA receptor modulators in a new MDD treatment paradigm. The
studies also support AV-101’s potential as a novel rapid onset treatment for
MDD.
“The relatively recent discovery of ketamine’s rapid onset
antidepressant effects revolutionized our thinking about antidepressant
medicine, ushering in development of a new generation of drug candidates with a
fundamentally novel mechanism of action compared to the agents that form the
mainstay of current depression treatment,” Dr. Sanacora stated. “VistaGen’s
AV-101 is among the new generation of antidepressants that modulate the NMDA
receptor and may act to normalize glutamate signaling to achieve the rapid and
sustained antidepressant benefits of ketamine without ketamine’s significant
negative side effects.”
In two randomized phase 1 safety studies funded by the National
Institutes of Health (NIH), AV-101 was well tolerated without any serious
adverse events or signs of sedation, hallucinations or the schizophrenia-like
side effects often associated with ketamine.
VistaGen has signed a Letter of Intent with the National Institute of
Mental Health (NIMH) to enter into a Cooperative Research and Development
Agreement (CRADA) to collaborate with Dr. Carlos Zarate and his colleagues at
the NIMH on an NIH-sponsored phase 2 clinical study of AV-101 in MDD. Under the
proposed CRADA, Dr. Zarate, who serves as chief of the Section on the
Neurobiology and Treatment of Mood Disorders and chief of the Experimental
Therapeutics and Pathophysiology Branch at the NIMH, will be the principal
investigator for the study.
For more information visit www.vistagen.com
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