VistaGen’s long-term relationship with global contract research and development organization expands to include right-of-first-offer for potential drug rescue candidates
South San Francisco, CA, February 8, 2012 / Marketwire / VistaGen Therapeutics, Inc. (OTC Bulletin Board: VSTA), a biotechnology company applying stem cell technology for drug rescue and cell therapy, has signed a strategic drug rescue agreement with Cato BioVentures and Cato Research.
The companies will join forces to identify, evaluate, rescue and develop once-promising new, small-molecule drug candidates discontinued in late-stage preclinical development by pharmaceutical developers due to heart or liver toxicity, despite positive efficacy data demonstrating their potential therapeutic and commercial benefits.
Shawn Singh, VistaGen’s Chief Executive Officer, stated, “Over the past 25 years, Dr. Allen Cato and Lynda Sutton have established Cato Research as a highly successful CRO with unique and long-standing relationships within a broad and diverse network of pharmaceutical companies and regulatory agencies around the world. This new agreement is a logical extension of our long-term relationship with both Cato BioVentures and Cato Research. It tightly aligns our stem cell technology-based drug rescue interests with Cato’s CRO growth goals and venture investment objectives. We believe the market demand for effective late-stage preclinical candidates with safety data generated with human heart cells and/or liver cells is strong and increasing. This relationship is yet another key component in our drug rescue ecosystem.”
Under the new agreement, when either Cato BioVentures or Cato Research first becomes aware of a new drug candidate meeting VistaGen’s drug rescue selection criteria, it will approach VistaGen with information about the candidate before any other organization. The expanded relationship is expected to provide VistaGen with potential drug rescue opportunities from within Cato’s broad CRO service and venture capital networks. If VistaGen rescues (generates a new chemical variant of) a drug rescue candidate presented by Cato Research or Cato BioVentures, VistaGen will discuss prospective CRO service opportunities for the new chemical entity with Cato Research before contacting any other CRO.
“By applying the power of human pluripotent stem cell technology, we believe VistaGen is transforming drug development. Its Human Clinical Trial in a Test Tube™ platform puts clinically relevant human heart and liver biology at the front end of the development process, long before human studies. We are pleased to join VistaGen’s efforts to identify and develop new drug candidates faster and less expensively through the use of its stem cell technology platform,” stated Allen Cato, M.D., Ph.D., co-founder and Chief Executive Officer of Cato Research.
About Cato Research and Cato BioVentures
Cato Research is a full-service contract research and development organization (CRO) with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics and medical devices to the people who need them. Cato BioVentures is the venture capital affiliate of Cato Research and one of VistaGen’s largest institutional shareholders. For nearly 25 years, Cato BioVentures and Cato Research have partnered with entrepreneurs, academic institutions and a broad base of biotechnology and pharmaceutical companies to advance a robust portfolio of successful product development and commercialization programs.
About VistaGen Therapeutics
VistaGen is a biotechnology company applying human pluripotent stem cell technology for drug rescue and cell therapy. VistaGen’s drug rescue activities combine its human pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube™, with modern medicinal chemistry to generate new chemical variants of once-promising small-molecule drug candidates. These are once-promising drug candidates discontinued by pharmaceutical companies during preclinical development due to heart or liver toxicity, despite positive efficacy data demonstrating their potential therapeutic and commercial benefits. VistaGen uses 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.
Additionally, VistaGen’s small molecule drug candidate, AV-101, is in Phase 1b development for treatment 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 development of AV-101 in the fourth quarter of 2012. VistaGen is also exploring 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 NIH for development of AV-101.
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 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.
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