would like to highlight VistaGen Therapeutics, Inc.
), a biotechnology company, focused on applying proprietary human pluripotent stem cell technology for drug rescue and cell therapy. Its Human Clinical Trials in a Test Tube is a pluripotent stem cell technology platform for predictive toxicology, drug development, and drug rescue.
In the company’s news,
VistaGen’s human pluripotent stem cell (hPSC) based approach to salvaging the massive outlays that are otherwise eaten when a once-promising drug candidate is dropped due to unexpected heart or liver toxicity complications (or preemptively preventing such losses), using their proprietary Human Clinical Trials in a Test Tube™ platform to accurately model the effects and develop safer Drug Rescue Variants™, also happens to be extremely useful for modeling non-toxic effects and thus represents a framework technology for drug development unlike anything which has come before it. The core component of this platform, an in-vitro bioassay system that utilizes functional/mature human heart cells derived from hPSCs to create three dimensional cardiac tissues, known as CardioSafe 3D™, is designed to be vastly more precise and expedient than extant surrogate safety models.
VistaGen recently reported (Apr 10) some big news in this area that will no doubt lead to key partnerings in future, as the company has become a member of the renowned public-private medical product cardiac safety research organization, the Cardiac Safety Research Consortium (CSRC), which was created back in 2006 via the FDA’s Critical Path Initiative MoU with Duke University. Since inception, the CSRC has come to be known as a driving force in public health and cardiac safety among the wide range of academic, governmental, and industrial stakeholders in the biopharma space which it engages in the support of these ends.
President of VSTA and the company’s CSO, Ralph Snodgrass, Ph.D., underscored the significance of mounting cardiac safety concerns associated with new drug candidates and the importance of identifying complications prior to human studies, further emphasizing that these concerns are the very internal mechanism which drives VSTA itself. Snodgrass also pointed to the key area of proarrhythmia safety, a serious and not infrequent complication in antiarrhythmic drugs where they actually provoke new arrhythmia (or a marked spike in the frequency of a preexisting arrhythmia), as being a primary target. Professor of Medicine at Duke and CSRC Co-Chair, Mitchell Krucoff, MD, FACC, hailed the start of a long and productive relationship with VSTA, noting the company’s commitment to proactive cardiac safety and how their membership strengthens the CSRC as well.
VSTA has winning technology here, with their ability to create a 3D bioassay that can be used to rapidly assess and benchmark new drugs, offering levels of detail and accuracy that make existing animal models or mere in-vitro cell culture approaches look like the antiquated technologies that they really are. The long-term potential for VSTA to prove up Drug Rescue Variants is enhanced by being able to make strategic connections through the CSRC membership and this relationship will help throw a spotlight on the compelling advantages of the company’s technology for predictive toxicology and drug metabolism assays, in addition to drug rescue.
Alongside CardioSafe 3D™, VSTA has developed a second major Human Clinical Trials in a Test Tube component, LiverSafe 3D™, designed to test drug-drug interactions and provide the same kind of over-the-horizon radar system for liver toxicology. In light of prior CardioSafe 3D™ developments regarding its use as a clinically predictive system for assessing cardiac toxicity in anti-cancer drugs, especially the revolutionary new small molecule kinase inhibitors which have drawn criticism (despite other benefits) for causing cardiac events not detected during drug development, this latest news about the CSRC membership is very bullish for VSTA and investors should keep an eye on the company as the broader biotech sector trims.
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