Thursday, May 1, 2014

VistaGen Therapeutics, Inc. (VSTA) Seeks to Bring Human Biology to Front End of Drug Development Process

In the late 1990s, VistaGen Therapeutics’ founders established the company to make their dreams a reality. The founders wanted to create human cell-based biological assay systems that provide reliable insight into the healing and harmful effects of new drug candidates long before they are ever tested in humans and, now, next-generation biological assays can provide the type and quality of valuable pre-clinical human data that will increase the possibility of choosing safer, more effective therapeutics for clinical development.

VistaGen’s drug rescue pursuits combine its human pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube™, with contemporary curative chemistry. By doing so, the company is able to produce newer, safer chemical variants (drug rescue variants) of once-promising small molecule drug candidates that were halted in development by the U.S. National Institutes of Health, pharmaceutical companies, or university laboratories because of heart or liver toxicity or metabolism issues. VistaGen uses its stem cell technology to create early predictions of how humans will eventually respond to the new drug candidates before they are ever tested in humans, bringing human biology to the start of the drug development process. Specifically, VistaGen applies its stem cell technology to drug rescue, predictive toxicology, and drug metabolism screening.

In the fifteen years since the California-based biotechnology company was founded, VistaGen has designed and developed CardioSafe 3D™, a high throughput, human heart cell-based bioassay. Recently, the company reported significant developments demonstrating that CardioSafe 3D is a clinically predictive system for the preclinical cardiac safety screening of anti-cancer drug candidates, including small molecule kinase inhibitors (KI), a new category of drugs that has transformed cancer therapy due to its increased target cell efficacy and reduced systemic toxicity when compared to classic cancer drugs.

The company is also developing and validating LiverSafe 3D™, a novel, three-dimensional in-vitro bioassay system for evaluating liver toxicity and drug metabolism issues.

VistaGen also has a small molecule drug candidate in development: AV-101, an orally available small molecule. AV-101 has completed Phase 1 development for the treatment of neurological diseases and disorders, including neuropathic pain, a serious and chronic condition that causes pain after an injury or disease of the peripheral or central nervous system and that affects millions of people worldwide.

For more information, visit www.vistagen.com.

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