VistaGen Therapeutics is bringing human biology to the front end of the long and costly drug development process. Among the most troubling aspects of drug development are unexpected heart and liver toxicities that often arise during human testing. Applying its stem cell technology and the human heart and liver cells it produces from stem cells, the company’s new generation of customized biological assay systems have been designed to predict early in development how humans will respond to new drug candidates in the long run.

In the years since VistaGen was founded, its technological advancements are finally catching on and allowing the founders of the company to realize their dream: to create the type and quality of human cell-based biological assay systems that provide a real understanding of the potential therapeutic and toxic effects of new drug candidates long before they are ever tested in animals or humans. Today’s next-generation biological assays are indeed providing crucial preclinical human cardiac data, soon to be followed by human liver data, that will increase the likelihood of selecting safer therapeutics for clinical development.

VistaGen has focused on developing various offerings over the years, including a novel clinical-stage drug therapy that has emerged as a leading new drug candidate in the multibillion dollar global antidepressant market. These offerings include:

• AV-101 – an orally-available small molecule drug candidate VistaGen has under clinical development. This therapy has completed the first phase of development for the treatment of a number of neurological diseases and disorders. This list includes Major Depressive Disorder and chronic neuropathic pain, both disabling conditions affecting millions around the world.

• CardioSafe 3D™ – the company’s human heart cell-based bioassay system that, following significant development, is demonstrating a propensity for being a clinically-predictive system for the preclinical cardiac safety screening of new drug candidates, including anti-cancer drug candidates such as kinase inhibitors, a new category of drugs that has revolutionized cancer therapy because of its increased target cell efficacy and reduced systemic toxicity when compared to classic cancer drugs and other therapeutic compounds. VistaGen is using CardioSafe 3D to expand its internal pipeline through various “drug rescue” programs. The goal of these drug rescue programs is to re-engineer or re-design (that is, rescue) once-promising new drug candidates developed by large pharmaceutical companies but abandoned before FDA-approval due to heart toxicity issues. The company believes the broad range of insightful heart toxicity data it can generate using CardioSafe 3D will give it a valuable head start in its and its collaborators’ efforts to re-design and develop a new, VistaGen-owned variant of these once-promising drug candidates, each with the same therapeutic potential as the original but without the heart toxicity issues.

• LiverSafe 3D™ – an innovative, customized, three-dimensional in-vitro bioassay system being validated to complement CardioSafe 3D for drug rescue applications. Using human liver cells produced from stem cells, the company is planning to use LiverSafe 3D™ to evaluate potential drug rescue candidates with metabolism and liver toxicity issues.

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