California based VistaGen Therapeutics, a biotech company focused on using their proprietary pluripotent stem cell technology for superior predictive toxicology and drug metabolism screening, is aggressively pursuing an innovative drug development path with unusually high profit potential. The company intends to identify once-promising small molecule drug candidates on which large amounts of research and development money has already been spent, but which have been discontinued and “shelved” due to unexpected safety concerns relating to heart or liver toxicity. The company’s one-of-a-kind bioassay platform, called Human Clinical Trials in a Test Tube, allows highly cost effective toxicity testing for heart and liver cells right in the laboratory, offering a unique way to quickly test and modify drug candidates, maintaining drug efficacy while eliminating toxicity.
VistaGen’s strategy leverages their developing stem cell technology based bioassay systems, CardioSafe 3D™ and LiverSafe 3D™, as well as their network of strategic relationships, and substantial prior third-party investment in drug discovery and development
The company’s approach is buoyed by the ongoing drug discovery and development crisis being experienced by the U.S. pharmaceutical industry. Last year, in spite of a $49 billion R&D investment by the pharmaceutical industry, the FDA’s Center for Drug Evaluation and Research approved only 39 novel NME (New Molecular Entity) drugs. Since 2003, the FDA has approved an average of only 26 NME’s annually. The high cost of drug development, coupled with this very low approval rate, means that such drug failures are a serious economic drain on the industry, and a potential economic catastrophe for the developing company.
A big part of the problem comes from known limitations of the industry’s current toxicological testing methodology, which relies primarily on animal models, transformed cell lines, or human cadaver cells. It’s an approach that can only approximate live human biology, and can lead to unpleasant surprises after millions or billions of dollars have already been spent on drug development.
VistaGen’s system offers mature human cells for more accurate and timely testing. It’s a technology of huge potential value to the industry, but also of value to VistaGen as a base for developing their own line of drug rescue variants.
For additional information, visit www.VistaGen.com
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