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VistaGen Therapeutics, Inc. (VSTA) Impressive in Predicting Test Outcomes of Vital Drug Candidates

VistaGen Therapeutics is keenly aware that despite decades of well-intentioned awareness and prevention campaigns, heart disease is still the leading cause of death for both men and women. The disease kills more than 600,000 Americans each year. According to the Center for Disease Control, approximately 49 percent of Americans have at least one of the three risk factors for heart disease – these being high blood pressure, high LDL cholesterol, and smoking. Despite researcher insights concluding that an overwhelming majority of heart disease is the result of poor lifestyle choices, scientists understand the statistics are dynamic in nature and must be constantly monitored.

VistaGen is a life sciences company that innovatively leverages its Human Clinical Trials in a Test Tube™ technology platform to provide clinically relevant predictions of potential toxicity of promising new drug candidates. Cardiovascular care is one of VistaGen’s particular areas of focus.

Unexpected safety concerns are pointed to as the reason why about one-third of all potential new drug candidates fail in preclinical or clinical development. It is believed that many lives could have been saved if it were not for promising cardiovascular drugs being discontinued because of late-stage failure. Using human heart cells derived from human pluripotent stem cells (hPSCs), VistaGen’s technology is designed to address potential toxicity of new cardiovascular drug candidates long before they are ever tested in humans.

CardioSafe 3D™, the company’s novel three-dimensional (3D) bioassay system, was developed to identify safer drug rescue variants with reduced heart safety concerns, which can be missed in animal models or in vitro cell culture testing currently used by biotechnology and pharmaceutical companies.

VistaGen’s plan is to combine CardioSafe 3D™ with modern medicinal chemistry to build a pipeline of safer chemical variants (Drug Rescue Variants™) of once-promising drug candidates that initially were developed by biotechnology and pharmaceutical companies, but were abandoned later due to the concerns mentioned earlier. Other notable work involves AV-101, the company’s lead small molecule drug candidate. The drug has successfully completed Phase I 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 millions of people worldwide. VSTA believes its Phase 1 safety program will enable Phase 2 development of AV-101 for neuropathic pain, depression, and potentially other neurological conditions. To date, VistaGen has been awarded over $8.8 million from the NIH for development of AV-101.

The core goal is to license or sell Drug Rescue Variants to biotechnology and pharmaceutical companies for further development and commercialization. VistaGen believes its strategy has the potential to substantially reduce drug development costs and produce effective and safer drugs, which would inherently help save human lives.

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