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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