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VistaGen Therapeutics, Inc. (VSTA)
Mission Statement: To develop innovative medicine for patients with depression and other unmet medical needs worldwide.
AV-101 for Depression
Depression is a global public health concern. The World Health Organization estimates that “depression is the leading cause of disability worldwide, and is a major contributor to the global burden of disease,” affecting 350 million people globally, including nearly 7% of adults in the United States.
Although antidepressant drugs are available, millions of depression patients are poorly served by current therapies, many of which require several weeks before therapeutic benefits are achieved.
Ketamine, a classic NMDA receptor (NMDAR) channel blocker, has been shown in clinical trials conducted by the U.S. National Institutes of Health (NIH) and others to act rapidly to alleviate symptoms of depression in treatment-resistant patients suffering with Major Depressive Disorder. However, the potential for widespread therapeutic 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 novel, potent, oral NMDAR glycineB-site antagonist. In preclinical studies, AV-101 has demonstrated the robust, fast-acting, antidepressant-like activity of ketamine, without any signs of ketamine’s serious side effects. In two randomized, double-blind, placebo-controlled Phase I clinical safety studies, AV-101 was well-tolerated, without any serious adverse events. There were no signs of sedation, hallucinations or the schizophrenia-like side effects often associated with ketamine therapy and other classic NMDAR channel blockers. We are preparing to initiate Phase 2 clinical development of AV-101 in Major Depressive Disorder in early-2015 as the next step in our efforts to address the high unmet need for a safe, faster-acting, more effective treatment for depression.
Stem Cell Technology-based Drug Rescue
VistaGen's versatile pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube™, has been developed to provide clinically relevant predictions of potential heart and liver toxicity of promising new drug candidates long before they are ever tested in animal or human studies.
With mature, adult human heart cells and liver cells produced using our proprietary stem cell technology, we have developed two customized bioassay systems, CardioSafe 3D™ and LiverSafe 3D™, for predicting heart toxicity and liver toxicity of new drug candidates in vitro, long before they are ever tested in animal or human studies. We use CardioSafe 3D and LiverSafe 3D to advance our internal drug rescue programs, which are focused on producing new, safer variants of drug candidates previously optimized and tested for efficacy by pharmaceutical companies but terminated before FDA approval due to heart or liver toxicity concerns. Our initial drug rescue programs are focused on novel therapies for cancer.
Chief Executive Officer - Shawn K. Singh, J.D.
Mr. Singh has over 20 years of experience working with successful public and private biotechnology and pharmaceutical companies, a life sciences venture capital firm, and a profitable contract research and development organization (CRO), serving in numerous senior management roles. Prior to joining us as Chief Executive Officer in August 2009, Mr. Singh served as Managing Principal of Cato BioVentures, the venture capital affiliate of Cato Research Ltd., a global, full-service CRO for which he served as Chief Business Officer. Mr. Singh also served as president and director of Echo Therapeutics (Nasdaq: ECTE), a medical device company developing its needle-free Symphony® tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system for use in hospital critical care units and for people with diabetes, and as Chief Business Officer of SciClone Pharmaceuticals (Nasdaq: SCLN), a revenue-generating, profitable, specialty pharmaceutical company with a substantial commercial business in China and a product portfolio of therapies for oncology, infectious diseases, and cardiovascular, urological, respiratory, and central nervous system disorders. Mr. Singh began his career as a corporate finance attorney in the Silicon Valley offices of Morrison & Foerster LLP, an international law firm. He is a member of the State Bar of California.
Founder, President, and Chief Scientific Officer - H. Ralph Snodgrass, Ph.D.
Dr. Snodgrass founded VistaGen in 1998 and served as our Chief Executive Officer until August 2009. He has over 18 years of experience in senior biotechnology management, including as Chief Scientific Officer of Progenitor, Inc. He has more than 10 years of research experience as a professor at the Lineberger Comprehensive Cancer Center, University North Carolina Chapel Hill School of Medicine, and as a member of the Institute for Immunology, Basel, Switzerland. Dr. Snodgrass is a past Board Member of the Emerging Company Section of the Biotechnology Industry Organization (BIO), and is a published and recognized pioneering expert in stem cell biology with more than 20 years' experience in the uses of stem cells as biological tools for drug discovery and development.
Acting Chief Financial Officer - Jerrold D. Dotson, CPA
Mr. Dotson brings a broad base of financial experience to VistaGen, joining as our Acting Chief Financial Officer (part-time) in September 2011. Most recently, he served as Corporate Controller for Discovery Foods. Mr. Dotson also held various positions in the finance and administration department of Calypte Biomedical Corporation, including his last position as Vice President of Finance and Administration and Corporate Secretary, California & Hawaiian Sugar Company, and The Clorox Company. He received his B.S. degree (Cum Laude) in accounting from Abilene Christian College and is a certified public accountant licensed in the State of California.
VP of Corporate Development - A. Franklin Rice, MBA
Mr. Rice joined VistaGen in 1999. He has been employed in the biotechnology industry since 1988 during which time he has served as Senior Director of Business Development at Genencor International and Vice President of Biotechnology and Pharmaceuticals for Bechtel Group where he was responsible for global sales and marketing of consulting services to biotechnology and pharmaceutical companies.