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08/18/14 - $15.00
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vistagen therapeutics inc (VSTA) Details

VistaGen Therapeutics, Inc., a biotechnology company, focuses on application and development of proprietary human pluripotent stem cell technology for drug rescue and regenerative medicine in the United States. The company is involved in the development of CardioSafe 3D, an in vitro bioassay system for assessing new drug candidates for potential cardiac toxicity before they are tested in animals or humans; and LiverSafe 3D, an in vitro bioassay system for potential drug-induced liver toxicity. It is also engaged in the development of AV-101, a prodrug candidate for the treatment of neuropathic pain, epilepsy, and depression that has completed Phase I development. In addition, the company focuses on Human Clinical Trials in a Test Tube, a stem cell technology platform for controlling the differentiation of human pluripotent stem cells into various types of mature, functional, and adult human cells. VistaGen Therapeutics, Inc. was founded in 1998 and is headquartered in South San Francisco, California.

9 Employees
Last Reported Date: 02/17/15
Founded in 1998

vistagen therapeutics inc (VSTA) Top Compensated Officers

Chief Executive Officer and Director
Total Annual Compensation: $250.0K
Founder, President, Chief Scientific Officer ...
Total Annual Compensation: $250.0K
Chief Financial Officer, Principal Accounting...
Total Annual Compensation: $200.0K
Compensation as of Fiscal Year 2014.

vistagen therapeutics inc (VSTA) Key Developments

VistaGen Therapeutics, Inc. and U.S. National Institutes of Health Sign Agreement for NIH-Sponsored Phase 2 Study of Orally-Active AV-101 in Major Depressive Disorder

VistaGen Therapeutics, Inc. has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. National Institute of Mental Health (NIMH), part of the U.S. National Institutes of Health (NIH). Under the CRADA, VistaGen and the NIMH will collaborate on an NIH-sponsored Phase 2 clinical study of AV-101, VistaGen's orally-active NMDA receptor modulator, in subjects with Major Depressive Disorder (MDD). MDD is a widespread and debilitating mental disorder affecting millions worldwide, including nearly 7% of U.S. adults. 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 Principal Investigator of the NIH-funded study, which will be a randomized, double-blind, placebo-controlled, crossover Phase 2 clinical trial designed to evaluate the efficacy and safety of a single oral dose of AV-101 administered once per day for 14 days to approximately 25 subjects with MDD. The primary efficacy measure will be the Hamilton Depression Rating Scale (HDRS), a standard scale for measuring depression severity. VistaGen and the NIH anticipate completing the study in 2015.

Gerard Sanacora Joins VistaGen Therapeutics, Inc.'s Clinical and Scientific Advisory Board

VistaGen Therapeutics, Inc. has added Gerard Sanacora PhD, MD, Professor of Psychiatry at the Yale School of Medicine and Director of the Yale Depression Research Program, to its Clinical and Scientific Advisory Board. 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.

VistaGen Therapeutics, Inc. Signs Letter Of Intent With National Institute Of Mental Health For Nih sponsored Phase 2 Clinical Study Of Av 101 In Major Depressive Disorder

VistaGen Therapeutics, Inc. has signed a Letter of Intent to enter into a Cooperative Research and Development Agreement (CRADA) with the National Institute of Mental Health (NIMH) to collaborate on a NIMH-sponsored Phase 2 clinical study of VistaGen's lead drug candidate, AV-101, in Major Depressive Disorder, one of the most common mental disorders in the U.S. The parties anticipate completing the definitive CRADA in December and both commencing and completing the Phase 2 depression study in 2015. AV-101, an oral, non-sedating, non-hallucinogenic, NMDA receptor (NMDAR) glycineB-site antagonist, is among a new generation of fast-acting, glutamatergic antidepressants with breakthrough potential to treat millions of depression patients who are poorly served by classic antidepressant therapies. Published NIH placebo-controlled clinical trials provide compelling evidence that ketamine, a classic NMDAR channel blocker, produces rapid-onset antidepressant effects. However, the clinical utility of ketamine, which is administered intravenously, and other NMDAR channel blockers has been severely limited by their potential for abuse and dissociative side effects, including hallucinations and schizophrenia-like effects. By regulating the NMDAR rather than blocking it, AV-101 has the potential to achieve the rapid-onset antidepressant effects of ketamine and other classic NMDAR channel blockers, without causing their serious side effects.


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