VistaGen Therapeutics was founded in the late 1990s by a
team of scientists believing that better cells lead to better medicine. In the
years since, this California-based clinical-stage biopharmaceutical company
also has focused on developing groundbreaking medicine for depression and other
diseases and conditions involving the central nervous system.
VistaGen continues to expand the scope of its pipeline
opportunities, employing its world-class biopharma expertise to gain a unique
position that allows it to pursue potentially valuable research and clinical
development collaborations. Last month, VistaGen revealed that it had signed a
valuable Cooperative Research and Development Agreement, or CRADA, with the
U.S. National Institute of Mental Health (NIMH), a division of the prestigious
U.S. National Institutes of Health (NIH). Under the new agreement, the NIMH and
VistaGen will collaborate on a fully-NIH-sponsored phase 2 efficacy study of
AV-101, the company’s orally-active NMDA receptor modulator for the treatment
of major depressive disorder (MDD).
Like ketamine, an anesthetic receiving a lot of attention
for its potential to treat MDD, AV-101 has a fundamentally novel mechanism of
action compared to all FDA-approved antidepressants and will be studied in
subjects with MDD, a far-reaching and devastating mental disorder affecting
millions of people around the globe. AV-101 differs from ketamine, however, in
that, in VistaGen’s NIH-funded phase 1 clinical studies, it produced no
ketamine-like psychotic side effects and it can be orally administered
(ketamine is administered intravenously).
The NIH-sponsored Phase 2 clinical trial will be a crossover
study conducted at the NIH and designed to assess the effectiveness and safety
of a single oral dose of AV-101 administered once a day for 14 days to
approximately 25 subjects with MDD. The study will be randomized, double-blind
and placebo-controlled, and the primary measure of effectiveness will be a
standard scale for measuring depression severity, the Hamilton Depression
Rating Scale. VistaGen and the NIH expect to announce the results of the study
near the end of 2015.
Dr. Carlos Zarate, 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 study’s chief investigator. Dr.
Zarate and his team have extensive clinical experience with ketamine and other
NMDA receptor modulators.
The VistaGen team is clearly excited by the strong
preclinical efficacy data supporting the potential antidepressant effects of
AV-101 similar to the results reported in NIH studies involving ketamine, as
well as the efficient oral-delivery and clinical safety range demonstrated by
its successful phase 1 clinical studies. The group looks forward to
collaborating closely with Dr. Zarate’s team to complete this important AV-101
Phase 2 study in MDD by year end.
Based on preclinical studies, AV-101 may also serve as a
potential treatment for other CNS-related conditions such as chronic
neuropathic pain and epilepsy, as well as neurodegenerative diseases such as
Parkinson’s disease and Huntington’s disease.
For more information, visit www.vistagen.com
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