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VSTA Tackling Expensive Problem of Drug Failure with Human Clinical Trials in a Test Tube™

With diseases such as Alzheimer’s, type 2 diabetes, and rheumatoid arthritis on the rise, there is a growing need for new and more effective treatments. But as an editorial by the Washington Post on new drug development initiatives by the National Institutes of Health makes clear, the cost of drug development failure is staggering—and widespread. According to the editorial, “taking a drug candidate from early discovery through Food and Drug Administration approval takes a decade and has a 95?percent failure rate.” Plus, with the cost of drug development being known to be able to exceed $1 billion, it is clear that pharmaceutical companies face a very uphill challenge in bringing blockbuster, high-therapeutic-potential drugs to market in today’s “drug approval climate”.

VistaGen Therapeutics, a California-based biotechnology company, meets this problem head-on with its Human Clinical Trials in a Test Tube™, a human pluripotent stem cell technology that enables biotechnology and pharmaceutical companies to identify unexpected heart or liver safety concerns before a drug candidate has journeyed far into its development process. With this “drug rescue” capability, biotechnology and pharmaceutical companies also become able to renew their bring-to-approval efforts of once-promising-but-now-backshelved drug candidates that were discontinued due to heart or liver safety issues.

According to a Forbes article in 2012, the sunk cost of a failed drug candidate for a big pharmaceutical company can be huge. The article notes that the cost of an average drug developed by a major pharmaceutical company is at least $4 billion. That is where the drug rescue potential of VistaGen Therapeutics’ technology becomes clear. VistaGen Therapeutics believes that conventionally used toxicological testing systems, such as animal testing and other nonclinical methods, do not closely approximate human biology enough to account for initially undetected liver and heart toxicity and metabolism issues. Human Clinical Trials in a Test Tube™, in contrast, enables the differentiation of human pluripotent stem cells into mature human cells. With these resources in hand, therapeutic solution developers then become able to identify any emerging liver or heart safety issues before a drug candidate has generated huge sunk costs in research and development.

Mr. Shawn Singh, J.D., Chief Executive Officer of VistaGen Therapeutics, has described the disruptive potential of Human Clinical Trials in a Test Tube™ as “game-changing”. Having noted that he has not seen anything like the ways VistaGen Therapeutics is applying stem cell technology in his broad professional career, Mr. Singh has signified his confidence that the human pluripotent stem cell technology could change the face—and cost dynamics—of American drug development and approval.

For more information, visit: http://www.VistaGen.com