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VistaGen Therapeutics, Inc. (VSTA)
Mission Statement: To develop innovative medicine for patients with depression and highly 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. According to the U.S. Centers for Disease Control and Prevention (“CDC”), about one in ten Americans aged 12 and over takes antidepressant medication.
Current medications in the multi-billion dollar global antidepressant market, including selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), have limited effectiveness. Because of their mechanism of action, SSRIs and SNRIs must be taken for several weeks before patients experience any significant therapeutic benefit. Only about 33% of depression sufferers benefit from first round treatment with SSRIs and SNRIs, and the likelihood of achieving remission of depressive symptoms declines with each successive treatment attempt. Although many patients may eventually find an antidepressant drug or drug combination that induces remission of their depressive symptoms after several treatment attempts, systemic effects of the antidepressant medications involved may increase the risks of serious side effects, including suicidal thoughts and behaviors. Suicide is estimated to be the cause of death in up to 15% of individuals with Major Depressive Disorder.
Ketamine, a classic NMDA receptor (NMDAR) channel blocker, has been shown in clinical trials conducted by the U.S. National Institutes of Health (NIH) to act rapidly to alleviate depressive symptoms in treatment-resistant patients suffering with MDD. Although the potential for widespread therapeutic use of ketamine is limited by its high risk for abuse and behavioral impairment, and its requirement for i.v. administration in a clinical setting, discovery of ketamine’s rapid-acting antidepressant effects revolutionized thinking about MDD treatment and stimulated drug development focused on new generation antidepressants, including AV-101, with potential for achieving fast-acting antidepressant effects similar to ketamine without ketamine’s side effects.
The fundamentally novel mechanism of action of VistaGen’s AV-101 places it among a new generation of antidepressants with breakthrough potential to treat millions of MDD sufferers poorly served by SSRIs and SNRIs. Like fast-acting ketamine, AV-101 modulates (down-regulates) NMDA receptor channel activity. However, unlike ketamine’s antagonistic activity, which results from blocking the NMDA receptor channel, AV-101’s antagonistic activity results from selectively binding to and blocking the functionally-required glycine-binding co-agonist site of the NMDA receptor, which may bypass potential adverse effects that occur with ketamine and result in the “glutamate surge” that has been associated with its rapid-acting antidepressant effects.
Following two successful NIH-funded Phase 1 safety studies of AV-101, VistaGen is now collaborating with the NIH on an NIH-funded Phase 2 clinical efficacy and safety study of AV-101 in subjects with MDD, to be completed in late-2015.
Stem Cell Technology-based Drug Rescue
VistaGen's versatile stem cell technology platform, Human Clinical Trials in a Test Tube™, provides 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.
VistaGen is also using its stem cell technology and customized CardioSafe 3D™ bioassay system for drug rescue, to produce proprietary new chemical entities (NCEs) that are safer variants of drug rescue candidates previously optimized for efficacy by pharmaceutical companies but terminated prior to FDA approval due to heart toxicity. VistaGen’s current CardioSafe 3D drug rescue program is focused on producing and validating a proprietary NCE 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.