The U.S. pharmaceutical industry is facing a "drug discovery and development crisis," says small-cap biotech VistaGen Therapeutics, evidenced by the fact that while the pharmaceutical industry in 2012 invested nearly $49 billion in R&D, a total of only 39 novel drugs were approved by the FDA. The hang-up is on the costly price tag of drug development and non-approval due to safety concerns of the candidates.
In recognition of this crisis, a movement toward the use of stem cell technology to address these issues has begun. VistaGen is already on board, leveraging its human cells derived from its human pluripotent stem cell (hPSC) technology, which it considers superior to major toxicological testing systems that use animal cells and cellular assays based on transformed cell lines and human cadaver cells, which at best only approximate human biology. The company believes it can develop better medicine by using its technology to provide clinically relevant biological information about a new drug candidate early in the drug development process, before time and money are spent on clinical trials.
In July 2013, the U.S. Food and Drug Administration (FDA) led a meeting with the FDA-sponsored Cardiac Safety Research Consortium, and the Health and Environmental Sciences Institute (HESI) to plan and discuss an overhaul to incorporate various individual ion channel assays and electrophysiological tests of stem cell-derived cardiomycocytes to revolutionize cardiac safety.
"The key thing we've realized over the last few years working on stem cells is that they are very much a game changer, particularly in cardiotoxicity," Nick Thomas, principal scientist in cell technologies at GE Healthcare in Cardiff, UK, told Kelly Rae Chi in a recent article in Nature Reviews.
As the FDA and its cohorts hammer out a schema to address toxicity concerns and the issues of the development of drug candidates, VistaGen continues to advance its technology portfolio. The company's Human Clinical Trials in a Test Tube™, is based upon a combination of the company's proprietary and exclusively licensed hPSC technologies. The platform assesses the toxicity and metabolism (drug-drug interaction) profile of new small molecule drug candidates applicable to a wide range of diseases and conditions. The platform is designed to work at an accelerated and more precise rate than non-clinical in vitro techniques and technologies currently used by biotechnology and pharmaceutical companies.
VistaGen's CardioSafe 3D™ novel biological assay system uses mature human heart cells derived from hPSCs to screen for heart toxicity in connection with the company's drug rescue activities. The company believes that CardioSafe 3D™ is stable, reproducible, and capable of generating data to allow more accurate in vitro prediction of the in vivo cardiac effects, both toxic and nontoxic, of promising new drug candidates long before they are tested in humans.
Furthermore, VistaGen believes the results of its internal validation studies indicate that CardioSafe 3D's efficacy in identifying safer drug rescue variants with reduced heart safety concerns, which can be missed in animal models or in vitro cell culture testing currently used by biotechnology and pharmaceutical companies.
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