VTGN Stock, VistaGen Therapeutics Inc. Information

VistaGen Therapeutics, Inc. is a clinical stage biopharmaceutical company dedicated to developing and commercializing innovative product candidates for patients with diseases and disorders involving the central nervous system CNS . VistaGen s lead product candidate, AV , is a next generation, orally available prodrug candidate in Phase development, initially for the adjunctive treatment of Major Depressive Disorder MDD in patients with an inadequate response to standard antidepressants. AV s mechanism of action, as an N methyl D aspartate receptor NMDAR antagonist binding selectively at the glycine binding GlyB co agonist site of the NMDAR, is fundamentally differentiated from all antidepressants, as well as all atypical antipsychotics used adjunctively with standard antidepressants, currently approved by the U.S. Food and Drug Administration FDA . VistaGen s ongoing Phase a clinical study of AV in subjects with treatment resistant MDD is being conducted and funded by the U.S. National Institutes of Mental Health NIMH under its February Cooperative Research and Development Agreement CRADA with the NIMH. This NIMH sponsored Phase a study was initiated in October and is ongoing. The Principal Investigator of the study is Dr. Carlos Zarate, Jr., Chief of the NIMH s Experimental Therapeutics amp Pathophysiology Branch and its Section on Neurobiology and Treatment of Mood and Anxiety Disorders. Previous NIMH studies, including studies conducted by Dr. Zarate, have focused on the effects of intravenous I.V. ketamine on depression. These NIMH studies, as well as clinical research by others, have demonstrated robust antidepressant effects in patients with treatment resistant MDD within hours of a single low dose of I.V. ketamine and stimulated research and development around a new generation of antidepressants with potential to deliver ketamine like fast onset benefits without its side effects. Currently, VistaGen is preparing to launch a Phase b clinical study of AV for the adjunctive treatment of MDD in patients with an inadequate response to standard antidepressants. VistaGen anticipates commencement of this potentially pivotal, multi center, multi dose, double blind, placebo controlled Phase b efficacy and safety study in the fourth quarter of . Dr. Maurizio Fava, Professor of Psychiatry at Harvard Medical School and Director, Division of Clinical Research, Massachusetts General Hospital MGH Research Institute and Executive Director, MGH Clinical Trials Network and Institute, will be the Principal Investigator of this Phase b study. VistaGen also believes AV has broad therapeutic utility with multiple near term CNS pipeline expansion opportunities, including chronic neuropathic pain, epilepsy, Huntington s disease and Parkinson s disease. VistaGen is also focused on potential commercial applications of its human pluripotent stem cell hPSC technology platform, including drug rescue to develop proprietary new chemical entities NCEs for its internal drug candidate pipeline, and, through potential strategic collaborations, regenerative medicine RM using blood, cartilage, heart and liver cells derived from its hPSC technology.