Friday, March 14, 2014

VistaGen Therapeutics, Inc. (VSTA) Poised to Revolutionize Clinical Trials and Pioneer hPSC Technology for Drug Rescue

Biotechnology company VistaGen Therapeutics is blazing trails with advances in pluripotent stem cell technology, operating on the belief that “Better Cells Make Better Medicine.”

Human Clinical Trials in a Test Tube is the company’s versatile human pluripotent stem cell (hPSC) technology platform, which has been developed to give clinically relevant predictions of the potential toxicity of promising new drug candidates long before they ever reach the human testing stage. VistaGen’s hPSC-based bioassay systems much more closely approximate human biology than the conventional animal testing and other nonclinical techniques and technologies currently being used in drug development.

VistaGen has expertise in applying hPSC technology for drug rescue, which includes predictive toxicology and drug metabolism screening. Through drug rescue, a combination of hPSC technology and medicinal chemistry is used to create new proprietary chemical variants, or Drug Rescue Variants, of small-molecule drug candidates that were once promising but were, after discovery and development, ultimately discontinued by biotechnology or pharmaceutical companies due to unexpected heart or liver safety concerns before they achieved market approval.

VistaGen believes Human Clinical Trials in a Test Tube enables heart and liver safety assessment of Drug Rescue Variants and other new drug candidates with greater speed and precision than currently used nonclinical drug development testing and technologies.

VistaGen’s primary aim is to generate a pipeline of Drug Rescue Variants and then license or sell them to biotechnology and pharmaceutical companies for further development and, ultimately, commercialization.

Currently, a significant stumbling block in the drug development process is the fact that conventional nonclinical surrogate safety models, such as live animal models, altered animal cells, immortalized and transformed cells, and explanted primary cells, can, at most, only approximate human biology in supporting important drug development decisions. Discontinuation due to unexpected heart or liver concerns means years of work and tens of millions of dollars can be lost after a biotechnology or pharmaceutical company attempts to discover, optimize, and validate a promising lead drug candidate’s potential efficacy and to advance its development. With VistaGen’s drug rescue model, however, substantial previous third-party discovery and development investments for once-promising drug candidates can be leveraged, along with the clinically predictive drug development capabilities of Human Clinical Trials in Test Tube™, to generate and assess key components of the heart and liver safety profiles of Drug Rescue Variants.

Parallel with its drug rescue activities, VistaGen intends to explore pilot nonclinical development opportunities related to regenerative cell therapy, with an emphasis on blood, heart, liver, and pancreas cells derived from hPSCs.

The company has successfully completed Phase 1 development of AV-101 with grant funding from the U.S. National Institutes of Health (NIH). AV-101 is an orally available small-molecule pro-drug candidate that is targeted at the multibillion-dollar neurological disease and disorders market, which includes neuropathic pain. VistaGen received more than $8.8 million in grant funding from the NIH to support its nonclinical and Phase I clinical development of AV-101.

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

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