Biotechnology company VistaGen Therapeutics is on the cusp of revolutionizing drug development with its Human Clinical Trials in a Test Tube™, a versatile stem cell technology platform that brings human biology to the frontend of the drug development process.
VistaGen has developed Human Clinical Trials in a Test Tube to provide clinically relevant predictions of the potential toxicity of promising new drug candidates long before they are ever tested on humans. Animal testing and other nonclinical techniques and technologies currently used in drug development can only approximate human biology at best, but the company’s human pluripotent stem cell-based bioassay systems much more closely emulate human biology. This will mean greater success for pharmaceutical companies and their potentially lifesaving drug candidates that get stymied at the human trial level.
Currently, a major stumbling block in the drug development process is that pharmaceutical companies can spend years and tens of millions of dollars discovering, optimizing and validating the potential efficacy of a lead drug candidate, advancing it through preclinical development, only to see it fail in human trials and be discontinued due to unanticipated heart or liver toxicity or metabolism issues. When a drug that has shown great therapeutic and commercial potential in preclinical development hits a dead end, a pharmaceutical company’s substantial prior investment may be lost and the world loses a potentially lifesaving or revolutionary drug.
VistaGen is working to break down this fundamental barrier to more efficient new drug development by meeting the great need for predictive toxicology screening systems. By surpassing the limitations of current animal and in vitro cell culture testing and more closely approximating human biology early on in the drug development process, VistaGen hopes to help pharmaceutical companies recapture significant value from their prior investments in formerly promising drug candidates that have been shelved due to heart or liver toxicity or metabolism concerns in humans.
The company’s goal is to use its stem cell technology to create a diverse pipeline of new, proprietary small molecule variants (drug rescue variants) of once-promising small molecule drug candidates that have been discontinued by pharmaceutical companies, the NIH, or academic laboratories. VistaGen believes that focusing solely on these discontinued drug candidates with positive preclinical efficacy data will offer a valuable head start in the company’s efforts to identify and develop new, safe drug rescue variants more quickly and cheaply than drug candidates that are being discovered and developed using conventional animal studies and in vitro cell culture testing systems.
Human Clinical Trials in a Test Tube™ will enable VistaGen and its medicinal chemistry partner to focus drug rescue efforts on generating safer, proprietary drug rescue variants that retain the promising efficacy of discontinued drug candidates but with reduced toxicity.
For more information, visit www.VistaGen.com
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