would like to highlight VistaGen Therapeutics, Inc.
), a biotechnology company, focused on applying proprietary human pluripotent stem cell technology for drug rescue and cell therapy. Its Human Clinical Trials in a Test Tube is a pluripotent stem cell technology platform for predictive toxicology, drug development, and drug rescue.
In the company’s news,
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.
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