VSTA Brings Human Biology to the Forefront of Drug Development
Biotechnology company VistaGen Therapeutics is engaged in applying human pluripotent stem cell technology for drug rescue, predictive toxicology, and drug metabolism screening. The company’s innovations are advancing drug development by predicting toxicity and other human response to new drug candidates long before they are ever tested in humans, thereby bringing human biology to the forefront of drug development.
VistaGen’s human pluripotent stem cell-based bioassay systems more closely emulate human biology than any of the conventional animal studies and other nonclinical techniques and technologies currently being used in drug development. The company believes its technology is the answer to the drug discovery and development crisis faced by U.S. pharmaceutical companies today.
Though billions of dollars are invested by the U.S. pharmaceutical industry each year for research and development, a relatively low number of novel drugs, known as new molecular entities (NMEs), are ultimately approved by the FDA. This is due in large part to unexpected heart and liver toxicity and metabolism issues. These unforeseen issues, the company believes, are often the result of the limitations of major toxicological testing systems currently being used in the pharmaceutical industry – namely animals and cellular assays that are based on transformed cell lines and human cadaver cells. VistaGen believes better cells make better bioassay systems – and VistaGen has better cells.
Human Clinical Trials in a Test Tube, VistaGen’s versatile stem cell technology platform, has been developed to give clinically relevant predictions of the potential toxicity of promising new drug candidates before the drugs ever reach human trials. Developed using pluripotent stem cell-derived human heart cells, the company’s CardioSafe 3D, a novel three-dimensional bioassay system, predicts the in vivo cardiac effects of new drug candidates prior to human testing. Also being developed is LiverSafe 3D, a novel predictive liver toxicology and drug metabolism screening system for drug rescue applications.
Using CardioSafe 3D and modern medicinal chemistry, VistaGen aims to build a pipeline of new, proprietary variants (drug rescue variants) of once-promising small molecule drug candidates that were discontinued by pharmaceutical companies, the NIH, and academic research institutions because of toxicity concerns – despite significant investment in the drugs and positive efficacy data signaling their potential therapeutic and commercial benefits.
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