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VistaGen Therapeutics, Inc. (VSTA)
VistaGen Therapeutics, Inc. (VSTA) is a biotechnology company applying stem cell technology for drug rescue and cell therapy. Drug rescue combines human stem cell technology with modern medicinal chemistry to generate new chemical variants ("drug rescue variants") of once-promising drug candidates that have been discontinued during late-stage preclinical development due to heart or liver safety concerns. VistaGen also focuses on cell therapy, or regenerative medicine, which includes repairing, replacing or restoring damaged tissues or organs
VistaGen's versatile 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 on humans.
By more closely approximating human biology than conventional animal studies and other nonclinical techniques and technologies currently used in drug development, VistaGen's human stem cell-based bioassay systems can improve the predictability of the drug development cycle and lower the cost of new drug research and development by identifying product failures earlier in the cost curve. According to the Food and Drug Administration even only a ten percent improvement in predicting failure before clinical trials could save $100 million in development costs, which savings ultimately could be passed on to patients.
Using mature human heart cells produced from stem cells, VistaGen has developed and internally validated CardioSafe 3D™, a novel three-dimensional (3D) bioassay system for predicting the in vivo cardiac effects of new drug candidates before they are tested in humans. VistaGen is now focused on using CardioSafe 3D™ to generate up to two new, safer small molecule drug rescue variants every twelve to eighteen months. VistaGen anticipates that these drug rescue variants will be modified versions of once-promising new drug candidates that have been discontinued by pharmaceutical companies and academic research institutions because of heart toxicity concerns, despite substantial prior investment and positive efficacy data demonstrating their potential therapeutic and commercial benefits. In most cases, VistaGen plans to license or sell its new, safer drug rescue variants in strategic partnering arrangements with global pharmaceutical companies, arrangements providing VistaGen with both near term and downstream milestone payments and economic participation rights but without future development cost obligations.
AV-101, VistaGen's lead small molecule prodrug candidate, has successfully completed Phase I clinical development in the U.S. for treatment of neuropathic pain, a serious and chronic condition affecting millions of people worldwide, depression, and other neurological diseases and conditions. To date, the U.S. National Institutes of Health (NIH) has awarded VistaGen over $8.75 million for development of AV-101. Management anticipates strategically out-licensing AV-101 to a development and marketing partner in 2013.
VistaGen is also developing LiverSafe 3D™, a novel predictive liver toxicity and drug metabolism bioassay system for drug rescue applications. In parallel with drug rescue activities, the Company is funding early-stage nonclinical studies focused on potential cell therapy applications of its Human Clinical Trials in a Test Tube™ platform.
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.