VistaGen Therapeutics, Inc. Reports Advances in Its Pancreatic Cell and Regenerative Medicine Programs

SOUTH SAN FRANCISCO, CA--(Marketwire - September 26, 2011) - VistaGen Therapeutics, Inc. (OTCBB: VSTA), a biotechnology company applying stem cell technology for drug rescue and cell therapy, announces the publication of its original research demonstrating the use of pluripotent stem cells to generate insulin in mice.

The research, titled Pdx1 and Ngn3 Overexpression Enhances Pancreatic Differentiation of Mouse ES Cell-Derived Endoderm Population, stems from a collaboration between VistaGen and the laboratories of Dr. Gordon Keller at the University Health Network’s McEwen Centre for Regenerative Medicine in Toronto and Dr. Atsushi Kubo at Nara Medical University in Japan. It was published in the peer-reviewed journal, PLoS ONE 6(9): e24058, doi: 10.1371/journal.pone.0024058 on September 13, 2011.

“In addition to presenting a powerful in vitro model system designed to screen for potential genes or drug candidates capable of inducing the production of insulin-secreting pancreatic beta-islet cells, these research results represent another important step towards our goal of developing superior biological systems for drug development,” said Dr. Ralph Snodgrass, President and Chief Scientific Officer of VistaGen. “We are grateful for the scientific contributions of our international collaborators to the research reported in this publication, as well as the continuing technical progress we are making through our ongoing and active partnership with Dr. Gordon Keller and his laboratory in Toronto.”

VistaGen has an established track record of advancing its internal commercially-focused research and development programs through collaborations that successfully combine the complementary capabilities of its industry leading scientists and those of academic leaders in the field of stem cell research. The published results are the culmination of a close and productive international collaboration initiated and led by VistaGen scientists in the United States.

These studies are part of VistaGen’s versatile Human Clinical Trials in a Test Tube™ platform which has proprietary applications in drug screening, cell therapy, and regenerative medicine in the areas of metabolic disease and diabetes. The stem cell-derived pancreatic cells developed by the international research team demonstrated the ability to produce and correctly process insulin and secrete C-peptide, characteristics of mature beta-islet cells. These studies confirm the utility of regulating two key developmental genetic signals for producing pluripotent stem cell-derived beta-islet cells that produce high levels of insulin. In addition, the specific precursor cell was identified that responds to these signals, suggesting a potential purification or enrichment strategy for beta-islet cell production, facilitating a strategy for the production of large numbers of beta-islet cells for multiple applications. Finally, these studies point to additional areas for future development as well as provide a strong foundation that supports VistaGen’s efforts to produce fully functional human beta-islet cells for drug discovery and clinical applications.

About VistaGen Therapeutics

VistaGen is a biotechnology company applying human pluripotent stem cell technology for drug rescue and cell therapy. Drug rescue involves the combination of human pluripotent stem cell technology with modern medicinal chemistry to generate new chemical variants of once promising small molecule drug candidates that pharmaceutical companies have discontinued during preclinical or early clinical development due to heart or liver toxicity, despite positive efficacy data demonstrating their potential therapeutic and commercial benefits. VistaGen plans to use its pluripotent stem cell technology to generate early indications, or predictions, of how humans will ultimately respond to new drug candidates before they are ever tested in humans.

In parallel with its drug rescue activities and in collaboration with Dr. Gordon Keller in Toronto, VistaGen is preparing to initiate pilot preclinical cell therapy programs involving the proprietary stem cell differentiation and cell production capabilities of its Human Clinical Trials in a Test Tube™ platform.

Additionally, VistaGen will begin a Phase 1b clinical study of AV-101, a small molecule drug candidate for treatment of neuropathic pain, before the end of 2011. This study includes testing AV-101 in healthy volunteers using the intradermal capsaicin model of neuropathic pain. Neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system, affects approximately 1.8 million people in the U.S. alone. VistaGen plans to initiate Phase 2 clinical studies of AV-101 in the fourth quarter of 2012. VistaGen is also exploring additional opportunities to leverage its current Phase 1 clinical program to enable additional Phase 2 clinical studies of AV-101 for epilepsy, Parkinson’s disease and depression. To date, VistaGen has been awarded over $8.5 million from the U.S. National Institutes of Health (NIH) for development of AV-101.

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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 regulatory approvals and the success of VistaGen’s ongoing clinical studies, including the safety and efficacy of its drug candidate, AV-101, the failure of future drug rescue and pilot preclinical cell therapy programs related to VistaGen’s stem cell technology-based Human Clinical Trial in a Test Tube™ platform, its ability to enter into drug rescue collaborations, risks and uncertainties relating to the availability of substantial additional capital to support VistaGen’s research, development and commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to AV-101 and any drug rescue variants identified and developed by VistaGen. 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.