Human Clinical Trials in a Test Tube™ - sounds like something out of a science fiction movie, but as it turns out, this is science reality. VistaGen Therapeutics is the developer of this versatile human pluripotent stem cell (hPSC) technology platform. The hPSC-based bioassay systems more closely approximate human biology than conventional animal testing and other nonclinical techniques currently being used, providing a high-potential path of success to the company's primary objective.
In line with its overarching goal to revive once-promising drug candidates (drug rescue variants) that were abandoned due to unexpected heart or liver safety concerns, VistaGen has used its hPSCs to develop CardioSafe 3D™. The bioassay system is used to predict the in vitro/in vivo cardiac effects of new drug candidates before they are tested on a human. VistaGen aims to combine CardioSafe with modern medicinal chemistry to build its pipeline of drug rescue variants.
hPSCs are also being used to develop LiverSafe 3D™ to assess potential liver toxicity and adverse drug-drug interactions among relative drug candidates. In addition, the company intends to advance pilot non-clinical development of regenerative cell therapy programs focused on blood, cartilage, heart, liver, and pancreas cells.
VistaGen's lead small molecule drug candidate, AV-101, has successfully completed phase 1 development for the treatment of neuropathic pain, a serious and painful condition following injury or disease of the peripheral or central nervous system. Building on the success of the first clinical trial, the company believes the safety program will enable phase 2 development of AV-101 for neuropathic pain, depression, and other neurological conditions.
VistaGen believes that its Human Clinical Trials in a Test Tube™ will enable the company to assess the heart and liver safety profile of drug rescue variants and other new drug candidates with greater speed and precision than conventional nonclinical testing and technologies used in drug development, supporting its goal of creating a pipeline of variants that can be licensed or sold to biotech and pharmaceutical companies for further development and commercialization.
For more information visit vistagentherapeutics.com
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