Biotechnology
company VistaGen Therapeutics is putting humans first with Human Clinical
Trials in a Test Tube. This human pluripotent stem cell (hPSC) technology
platform has been developed to provide clinically relevant predictions of
potential toxicity long before drug candidates are ever tested on humans.
VistaGen’s
hPSC-based bioassay systems simulate human biology much more effectively than
animal testing and other nonclinical techniques and technologies currently used
in drug development. This superior approximation of human physiology enables
pharmaceutical companies to better predict potential pitfalls in promising drug
candidates during preclinical development – potentially saving millions of
dollars and countless hours. Many times, a drug candidate that showed great
promise during preclinical testing ultimately fails in human trials due to
unforeseen heart or liver toxicity or metabolism issues. That quickly, a
potentially lifesaving drug candidate is lost to the world. Thanks to
VistaGen’s pioneering efforts, however, the limitations of animal and in vitro
testing have been overcome and once-promising drug candidates can potentially
have a second chance to be brought successfully through clinical trials.
Human Clinical
Trials in a Test Tube provides priceless toxicology prediction screening long
before human subjects ever encounter a drug. With this hPSC technology,
VistaGen can not only help pharmaceutical companies enjoy greater success in
their drug development efforts, but the company can also create its own diverse
pipeline of new proprietary drug rescue variants, revisiting discontinued
small-molecule candidates that were shelved due to adverse reactions in humans.
VistaGen is
currently developing two predictive biological assay systems: CardioSafe 3D and
LiverSafe 3D. CardioSafe 3D uses mature human heart cells derived from hPSCs to
screen for heart toxicity in connection with the company’s drug rescue
activities. LiverSafe 3D, being developed in collaboration with leading stem
cell researcher Dr. Gordon Keller, will similarly offer valuable predictive
screening data relating to liver toxicity and metabolism issues.
For more information
about VistaGen and its advancements, visit www.VistaGen.com
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