VistaGen Therapeutics, Inc. (VSTA) Human Clinical Trials in a Test Tube Platform a Drug Discovery and Rescue Gold Mine

VistaGen Therapeutics, the rapidly evolving biotech firm that is advancing a stem cell-based technology platform focused on controlling pluripotent stem cell differentiation for application in drug rescue initiatives and next generation pharmaceutical assays for testing potential heart and liver toxicity of new drugs, possesses a game-changing bioassay system with CardioSafe 3D™.

Here we have a stable test bed derived from stem cells differentiated into mature human heart cells that can be used to screen drug candidates for in vivo cardiac results (toxic or nontoxic) with an incredible degree of accuracy due to how closely the bioassay system approximates human cardiac biology. This bioassay technology is far superior to animal testing and provides an alternative to human testing which normally takes many years and millions of dollars to advance through all of the necessary procedures required to get meaningful data, at which point toxic effects could render much of the expended effort wasted.

With a proprietary and licensed method for constructing 3D micro-heart cultures that mature into complete tissue structures, VSTA has their hands on the brass ring of predictive toxicology in a format that overcomes the competition due to mirroring what an actual human trial would potentially look like. Moreover, these 3D tissue structures produce a much higher fidelity data feed than traditional flat 2D assays, which don’t really function properly for a whole range of reasons that basically come down to actual tissues not existing in the body as a thin, isolated 2D slice, but rather as 3D cell networks.

CardioSafe 3D gives drug development efforts a clinically relevant framework in which to gauge the effects of a drug candidate on the heart long before human testing would ever be possible, potentially saving millions and also offering a massive pipeline for drug rescue in the event that a drug is found unsafe and subsequently discontinued. In fact, this is where VSTA has stepped in strategically to capture otherwise promising drug candidates that have been shelved due to heart (and eventually liver) toxicity, leveraging the power of their Human Clinical Trials in a Test Tube™ technology platform to identify and pursue safer drug rescue variants with all the efficacy of the original, but without the toxic effects. CardioSafe 3D mature heart cells even represent a superior, more expedient methodology than nonclinical in vitro techniques currently employed in drug development by most of the pharmaceutical companies in the field today.

Drug development these days can cost Big Pharma in the neighborhood of around $800M to $1.7B, possibly billions more, while taking ten to fifteen years to commercialize just one candidate. Having to mothball a candidate after that kind of capital outlay is a huge set back. In fact, one in three potential new drugs ends up this way and that is why the company has been gearing up to unearth the buried investments. New technology like the company’s LiverSafe 3D™, a cell-based bioassay system in development utilizing human liver cells derived from stem cells, shows the extensibility of VSTA’s drug rescue capabilities and this sort of bioassay/drug rescue variant synergy should tell investors a great deal about the future of such packaged culture analysis using stem cell derived tissue.

It is the clear technological might of this stem cell based platform that spells abundant licensing potential for the bioassay applications in drug development, and one must marvel at the true, long-term possibilities with controlled differentiation of human pluripotent stem cells into mature, fully functional cell types for vetting a whole range of chemical interactions and drug rescue opportunities. It is as close to a human on a chip as anyone is getting today, and with a slew of companies jumping into the thriving research model business, VSTA represents a compelling alternative with a boldly unique IP portfolio.

Harvesting the vast profitability from a diverse, proprietary array of small molecule drug rescue candidates, redeemed from discontinuation after large investments by pharmaceutical giants and chosen for positive preclinical vectors, is a really good strategy for VSTA and its extensive ecosystem of drug rescue collaborators. In today’s pharmaceutical marketplace, with the skyrocketing costs of drug development and threats from generic competition, the strength and necessity of the human clinical trials in a test tube cannot be denied. The ability of in vitro bioassay technologies like CardioSafe 3D and LiverSafe 3D™ to address the FDA’s modest annual approval rate of new drugs over the last ten years (only about 25 per year) is obvious.

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

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