VistaGen’s drug rescue strategy involves: (1) using VistaGen’s customized in vitro bioassay systems, CardioSafe 3D™ and LiverSafe 3D™, to predict potential heart and liver toxicity of NCEs long before testing in animal and human studies; (2) recapturing value from substantial prior investments by pharmaceutical companies and others related to screening large-scale compound libraries, optimizing and testing for efficacy NCEs that were terminated before FDA approval due to heart, and eventually liver, toxicity and are now available in the public domain; and (3) applying medicinal chemistry to produce safer proprietary NCEs for the Company’s internal development pipeline.
VistaGen’s CardioSafe3D bioassay system uses the Company’s human pluripotent stem cell (hPSC)-derived cardiomyocytes, or human heart cells. VistaGen believes CardioSafe3D is more comprehensive and clinically predictive than the hERG assay, which is currently the only in vitro cardiac safety assay required by FDA guidelines. VistaGen is using the Company’s stem cell-derived hepatocytes, or human liver cells, to validate the LiverSafe3D bioassay system and predict potential liver toxicity of NCEs, including potential drug metabolism issues and adverse drug-drug interactions. CardioSafe 3D and, when validated, LiverSafe3D offer a new paradigm for evaluating and predicting potential heart and liver toxicity of NCEs, including drug rescue NCEs, early in the development process, long before costly, high risk animal studies and human clinical trials. VistaGen’s goal is to expand our proprietary pipeline by internally developing each lead drug rescue NCE the Company produces.
We are able to grow large numbers of normal, non-transformed, human cells to produce novel in vitro 3D “micro-organ” culture systems which induce the cells to grow, mature, and develop 3D cell networks and tissue structures. We believe these 3D cell networks and structures can more accurately reflect the structures and biology inside the human body than traditional flat, 2D, single cell layers grown on plastic and often used in drug discovery and development. We believe the more representative human biology afforded by our 3D bioassay systems yield valuable data relating responses to drug candidates, responses that are clinically predictive of human drug responses.