VistaGen Therapeutics, Inc. (VSTA) – Applying Stem Cell Technology toward Drug Rescue and New Generation Drug Toxicity Screening

Believing that better cells lead to better medicine, VistaGen Therapeutics has been applying pluripotent stem cell technology toward drug rescue, predictive toxicology and drug metabolism screening.

VistaGen’s activities are guided by the belief that the key to making better cells is strictly controlling the differentiation of human pluripotent stem cells, the building blocks of all cells in the human body. For more than 15 years, the company’s stem cell research and development teams and collaborators have developed proprietary methods for controlling the differentiation of human pluripotent stem cells and the production and maturation of several specific types of adult human cells, particularly human heart and liver cells.

VistaGen’s drug rescue activities are focused on combining its stem cell technology and assay development expertise with modern medicinal chemistry to produce drug rescue variants – new, safer chemical variants of once-promising drug candidates that have positive data supporting their therapeutic and commercial potential, but that were halted in development by the pharmaceutical companies or university laboratories because of concerns about potential heart or liver toxicity or metabolism issues.

In the years since VistaGen was founded, the California-based biotechnology company has developed two customized bioassay systems designed to transform drug development by establishing clinically-predictive, human cell-based toxicology screening at the front end of the development process, long before animal or human studies:

•           CardioSafe 3D™ – This customized human heart cell bioassay system for screening potential heart toxicity of new drug candidates uses mature, functional, adult human heart cells produced from pluripotent stem cells (VSTA-CMs™) to detect a far broader range of potential cardiac toxicities than the FDA-required hERG assay, and it provides proprietary cardiac toxicity and quantitative structure-function (QSAR) information to guide highly-efficient selection and development of proprietary drug rescue candidates for VistaGen’s pipeline.

•           LiverSafe 3D™ – VistaGen is developing and validating this innovative, three-dimensional in-vitro bioassay system designed to evaluate liver toxicity and drug metabolism issues. LiverSafe 3D uses VSTA-heps™, VistaGen’s pluripotent stem cell-derived, mature adult human hepatocytes (liver cells). VSTA-heps have significantly more functionally useful life span in culture than primary (cadaver) hepatocytes and overcome the key problems related to use of primary hepatocytes for in vitro liver safety toxicity and drug metabolism screening, including: extreme variation in functional activity; limited supply; unknown health status of donor; and genetic differences.

VistaGen continues employ its world-class stem cell differentiation and bioassay development expertise to expand the scope of its drug rescue, drug discovery and strategic collaboration opportunities worldwide.

For more information, visit the company’s website at www.vistagen.com

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