Approximately one-third of all potential new drug candidates are shelved in their late-stage development due to preclinical or clinical safety concerns. As a result, in the last decade the number of new drugs that are approved each year has dramatically dropped, as much as 50 percent according to some estimates, though in the same 10-year span there has been an increase in funding for the development of these drug candidates.
To those paying attention to the healthcare industry, the low yield of these investments was not and has not gone unnoticed. In 1998, Drs. Ralph Snodgrass and Gordon Keller, both renowned leaders in stem cell biology, found that they shared a common vision to develop stem cell technology that could revolutionize the way drugs are discovered and developed.
VistaGen Therapeutics was the result of this vision, a biotech company dedicated to transforming global drug development. The company’s core focus is on drug rescue using its proprietary stem cell technology platform to revive once-promising drugs that for one reason or another were discontinued in late stage preclinical development. VistaGen’s particular interest is on drug variants that were discontinued due to heart toxicity concerns.
Leveraging its Human Clinical Trials in a Test Tube™ technology, VistaGen’s strategy is to generate a pipeline of drug candidates and then partner with the right industry players to move these drug rescue variants into commercialization.
Human Clinical Trials in a Test Tube™ combines the company’s proprietary and exclusively licensed human pluripotent stem cell (hPSC) technologies to enable the controlled differentiation of hPSCs into mature, functional human cells that could lead to the identification of drug candidates with human toxicity or metabolism issues. The revolutionary characteristic of this process is that these safety issues can be detected early in the drug development process, drastically reducing development costs.
Thus far, VistaGen has utilized mature heart cells produced from stem cells to develop the CardioSafe 3D bioassay system, which can predict both toxic and non-toxic in vivo cardiac effects of a drug candidate before it is ever tested on a human being. The company’s LiverSafe 3D has the potential to assess potential liver toxicity and adverse drug-drug interactions among relative drug candidates.
The company also intends to advance pilot non-clinical development of regenerative cell therapy programs focused on blood, cartilage, heart, and liver and pancreas cells.
For more information, visit www.vistagen.com
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