Friday, May 30, 2014

VistaGen, Inc. (VSTA) Aims to Breathe Life into Shelved, High Potential Drug Candidates and Revitalize Drug Development

VistaGen is a biotech company applying pluripotent stem cell technology for drug rescue and regenerative medicine with a primary focus on heart and liver cells. A pluripotent stem cell, such as an embryonic stem cell, has the potential to differentiate into a variety of other cell types in a body, making it a valuable component in regenerative medicine.

The term “drug rescue” refers to R&D using small molecule drug candidates that were previously discovered and validated in efficacy studies, but that were dropped during development, prior to FDA approval, due to unexpected safety concerns. VistaGen’s mission is to develop a means to predict these toxicity concerns in early development, before the pharmaceutical developer spends considerable time and money on animal or human testing.

For more than 15 years, the company’s stem cell R&D teams have worked alongside key collaborators to develop proprietary methods for facilitating controlled-differentiation of pluripotent stem cells to produce several types of mature, functional adult human cells.

The result of these efforts are the CardioSafe 3D™ and LiverSafe 3D™ in vitro bioassay systems, which form the cornerstone of the company’s Human Clinical Trials in a Test Tube™ platform.

Using mature cardiomyocytes (heart cells) differentiated from human pluripotent stem cells, VistaGen developed its CardioSafe 3D™ to predict toxic and non-toxic in vivo cardiac effects of small molecule drug candidates. LiverSafe 3D™, the company’s second novel stem cell technology-based bioassay system, was developed using mature hepatocytes (liver cells) and was also derived from human pluripotent stem cells.

Unexpected toxicity is one of the top reasons for safety-related drug failure during clinical development. Because VistaGen’s systems use human stem cells rather than animal, cadaver, immortalized or transformed cells, and are three dimensional cultures, its technology more accurately reflects the structures and biology inside the human body, giving it the power yield responses to drug candidates that are more predictive of human drug responses.

VistaGen continues to advance the pharmaceutical applications of stem cell-derived blood, bone, cartilage, heart, liver and pancreatic beta-islet cells, while exploring opportunities to leverage its stem cell technology platform for regenerative medicine purposes.

The company’s goal is to utilize its drug rescue programs to recapture the substantial value invested by pharmaceutical companies and others into once promising drug candidates, and to build a diverse pipeline of new, proprietary small molecule variants of discontinued candidates.

For more information, visit www.vistagen.com

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