SAN FRANCISCO, Oct. 7, 2015 /PRNewswire/ -- VistaGen Therapeutics, Inc. (OTCQB: VSTA), a clinical-stage biopharmaceutical company committed to developing and commercializing novel medicines to treat depression, cancer and diseases and disorders involving the central nervous system (CNS), today announced that Maurizio Fava, MD, a world renowned expert in depressive disorders and psychopharmacology, has joined the Company's Clinical and Scientific Advisory Board, effective immediately. Dr. Fava is Director of the Division of Clinical Research of the Massachusetts General Hospital (MGH) Research Institute, Executive Vice Chair, Department of Psychiatry at MGH, and Executive Director of the MGH Clinical Trials Network and Institute (CTNI), as well as Slater Family Professor of Psychiatry at Harvard Medical School. He co-developed, with Dr. David Schoenfeld, Professor of Biostatistics at the Harvard School of Public Health, a novel, patented clinical trial design which increases the probability of detecting a positive drug response, while markedly reducing sample size requirements for the trial, by reducing the potentially high placebo response sometimes found in depression, and other, clinical trials.
"We are honored to welcome Dr. Fava to our Clinical and Scientific Advisory Board," stated Shawn Singh, Chief Executive Officer of VistaGen. His leading-edge expertise and guidance will make a significant impact on our clinical development of AV-101 as a new generation, orally-available prodrug candidate for the treatment of Major Depressive Disorder (MDD) and other CNS indications with high unmet need."
Commenting on his appointment, Dr. Fava noted, "I am pleased to join VistaGen's Clinical and Scientific Advisory Board. MDD is a pervasive, debilitating condition which is growing in incidence and, as a result, is a major global health concern. Given the limitations inherent in currently available medications for MDD, including selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs), there exists an urgent need for development of new, alternative therapies involving a different mechanism of action to treat this patient population."
Dr. Fava founded and was Director of the MGH Depression Clinical and Research Program (DCRP) from 1990 until 2014. Under his direction, the DCRP became one of the most highly regarded depression programs in the United States. Dr. Fava was co-Principal Investigator, with Dr. A. John Rush, of the largest clinical trial ever conducted in depression, STAR*D, whose findings were published in journals such as the New England Journal of Medicine (NEJM) and the Journal of the American Medical Association (JAMA). Dr. Fava recently served as President of the American Society of Clinical Psychopharmacology (ASCP).
During his career, Dr. Fava has authored or co-authored more than 600 original articles published in medical journals with international circulation. The citation impact of Dr. Fava's work is extremely high, as his articles have been cited more than 40,000 times in the literature. He has edited eight books, published more than 50 chapters and 600 abstracts, and has given more than 350 presentations at national and international meetings. He is the recipient of several awards, and is on the editorial board of five international medical journals.
About VistaGen Therapeutics
VistaGen Therapeutics, Inc. is a clinical-stage biopharmaceutical company committed to developing and commercializing novel medicines to treat depression, cancer and diseases and disorders involving the central nervous system (CNS). VistaGen's AV-101 is a new generation orally-available NMDAR GlyB antagonist in Phase 2 clinical development for Major Depressive Disorder. Based on preclinical studies, AV-101 may also have potential as a treatment for other CNS-related conditions, including chronic neuropathic pain and epilepsy, as well as neurodegenerative diseases such as Parkinson's disease and Huntington's disease. VistaGen is also using its pluripotent stem cell technology platform for potential commercial applications focused on producing proprietary new chemical entities (NCEs) through drug rescue and regenerative therapies for diseases and conditions related to blood, cartilage, heart and liver cells. For additional information, please visit www.VistaGen.com.
Cautionary Statement Regarding Forward-Looking Statements
The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to the VistaGen's successful Phase 2 clinical development of AV-101 in MDD, its stem cell technology-based drug rescue activities, protection of its intellectual property, and the availability of substantial additional capital to support its operations, including the foregoing activities. These and other risks and uncertainties are identified and described in more detail in VistaGen's filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC's website at www.sec.gov. VistaGen undertakes no obligation to publicly update or revise any forward-looking statements.
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SOURCE VistaGen Therapeutics, Inc.
Released October 7, 2015