Collaboration Focused on Improving Cardiac Safety of Medical Products Based Upon Principles of FDA's Critical Path Initiative
SOUTH SAN FRANCISCO, CA -- (Marketwired) -- 04/10/14 -- VistaGen Therapeutics, Inc. (OTCQB: VSTA), a biotechnology company applying pluripotent stem cell technology for drug rescue and regenerative medicine, today announced that it has become a member of the Cardiac Safety Research Consortium (CSRC), launched in 2006 through an FDA Critical Path Initiative Memorandum of Understanding with Duke University to support innovative research into the evaluation of cardiac safety of medical products.
Using mature, functional heart cells differentiated from human pluripotent stem cells, VistaGen has developed CardioSafe 3D™, a novel in vitro bioassay system capable of predicting the cardiac effects, both toxic and non-toxic, of small molecule drug candidates with greater speed and precision than surrogate safety models most often used in drug development, including animal models and cellular assays using primary, immortalized or transformed cells. CardioSafe 3D is the core component of VistaGen's stem cell technology platform, Human Clinical Trials in a Test Tube™.
"We look forward to partnering with the pharmaceutical, biotechnology, academic, and regulatory members of the Cardiac Safety Research Consortium, and contributing our expertise to support rapid advancement of our understanding of cardiac safety. Cardiac safety, especially identifying proarrhythmic safety concerns of new drug candidates prior to human studies, drives our internal efforts every day, and we welcome the opportunity to participate in this innovative process with the consortium," said Ralph Snodgrass, Ph.D., VistaGen's President and Chief Scientific Officer.
"VistaGen shares our commitment to improving cardiac safety of new medical products, and its membership will strengthen CSRC," said Mitchell W. Krucoff, MD, FACC, Professor of Medicine at Duke University and CSRC Co-Chairperson. "We look forward to a productive, long-term relationship with VistaGen."
About Cardiac Safety Research Consortium (CRSC)
The Cardiac Safety Research Consortium is a public-private partnership launched in 2006 through an FDA Critical Path Initiative Memorandum of Understanding with Duke University to support research into the evaluation of cardiac safety of medical products. CSRC supports research by engaging stakeholders from industry, academia, and government to share data and expertise in a collaborative environment based upon the principles of the FDA's Critical Path Initiative as well as other public health priorities with regard to cardiac safety.
About VistaGen Therapeutics
VistaGen is a stem cell company headquartered in South San Francisco, California and focused on drug rescue and regenerative medicine. We believe better cells make better medicine™ and that the key to making better cells is precisely controlling the differentiation of human pluripotent stem cells, which are the foundation cells of the human body. For almost 15 years, our stem cell research and development teams and collaborators have focused on controlling the differentiation of human pluripotent stem cells. Our drug rescue activities combine our human pluripotent stem cell technology with medicinal chemistry to generate novel, safer chemical variants (Drug Rescue Variants™) of once-promising small molecule drug candidates. These are drug candidates discovered, developed and ultimately discontinued by pharmaceutical or biotechnology companies, the U.S. National Institutes of Health (NIH) or university laboratories, after substantial investment due to unexpected safety concerns relating to the heart or liver.
VistaGen's small molecule prodrug candidate, AV-101, has successfully completed Phase 1 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 millions of people worldwide.
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 the success of VistaGen's stem cell technology-based drug rescue activities or further clinical development and commercialization of AV-101, its ability to enter into strategic partnering arrangements, and risks and uncertainties relating to the availability of substantial additional capital to support its research, drug rescue and drug development activities. 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.
For more information: Shawn K. Singh, J.D. Chief Executive Officer VistaGen Therapeutics, Inc. www.VistaGen.com 650-577-3613 Investor.Relations@VistaGen.com Mission Investor Relations IR Communications Atlanta, Georgia www.MissionIR.com 404-941-8975 Investors@MissionIR.com
Source: VistaGen Therapeutics, Inc.
Released April 10, 2014