Since inception, VistaGen Therapeutics has focused on
creating human cell-based biological assay systems that reveal the potential
toxic effects of new drug candidates before they are tested in animals or
humans. Today’s next-generation biological assays are delivering needed
preclinical human cardiac data, soon to be followed by human liver data, that
will increase the likelihood of selecting safer therapeutics for clinical
development.
AV-101 is VistaGen’s proprietary, novel oral clinical-stage
drug candidate that is fast emerging as a prominent player in a small group of
new generation of drug candidates focused on the multi-billion dollar global
antidepressant market.
Despite the availability of numerous very similar
antidepressant drugs over the past 50 years, millions of depression patients
remain underserved by their current therapies and many require several weeks
before therapeutic benefits are achieved. Ketamine, a classic NMDA receptor
(NMDAR) channel blocker, has been shown in human clinical studies run by the
U.S. National Institutes of Helath (NIH) and others to act rapidly to alleviate
symptoms of depression in treatment-resistant patients suffering with Major
Depressive Disorder (MDD). However, the potential for widespread clinical and
commercial use of ketamine has been severely limited by its high risk for abuse
and behavioral impairment, and its requirement for i.v. administration in a
clinical setting. VistaGen’s AV-101 is a oral, NMDAR glycine (B)-site
antagonist, with a novel mechanism of action compared to all currently
available antidepressants. In two randomized, double-blind, placebo-controlled
Phase I clinical studies, AV-101 was well-tolerated, without serious adverse
outcomes. AV-101 has the potential to deliver the rapid onset antidepressant
effects of ketamine without ketamine’s –psychosis-like side effects. VistaGen
and the NIH are currently planning to collaborate on an important NIH-sponsored
Phase 2 clinical efficacy study of AV-101 in MDD patients in 2015.
For more information on the company and its offerings, visit
www.vistagen.com
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