VistaGen’s versatile stem cell technology platform, Human Clinical Trials in a Test Tube™, has been developed to provide clinically relevant predictions of potential toxicity of promising new drug candidates long before they are ever tested on humans. Our human pluripotent stem cell-based bioassay systems more closely approximate human biology than conventional animal studies and other nonclinical techniques and technologies currently used in drug development.
News and Upcoming Events
Neuropathic pain affects approximately 1.8 million people in the U.S. alone. To date, we have been awarded over $8.5 million from the U.S. National Institutes of Health (NIH) to develop AV-101 for neuropathic pain.
With human heart cells derived from pluripotent stem cells, we developed CardioSafe 3D™, a novel three-dimensional (3D) bioassay system for predicting the in vivo cardiac effects of new drug candidates before they are tested in humans. We plan to use CardioSafe 3D™ to build a pipeline of small molecule drug rescue variants of once-promising drug candidates that have been “put on the shelf” by pharmaceutical companies and academic research institutions because of heart toxicity concerns, despite positive efficacy data signaling their potential therapeutic and commercial benefits.
Our lead small molecule drug candidate, AV-101, is in Phase Ib development in the U.S. for treatment of neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system. Neuropathic pain affects approximately 1.8 million people in the U.S. alone. We believe our Phase 1 safety studies also will enable Phase 2 development of AV-101 for epilepsy, Parkinson’s disease and depression. To date, we have been awarded over $8.5 million from the U.S. National Institutes of Health (NIH) for development of AV-101.
With human liver cells derived from pluripotent stem cells, we are developing LiverSafe 3D™ as a novel predictive liver toxicity and drug metabolism bioassay system for drug rescue applications. In parallel with our drug rescue activities, we are funding early-stage nonclinical studies focused on potential cell therapy applications of our Human Clinical Trials in a Test Tube™ platform. Each of these nonclinical studies is based on the proprietary human pluripotent stem cell differentiation and cell production capabilities of our Human Clinical Trials in a Test Tube™ platform.
