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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