VistaGen Therapeutics, Inc. (VSTA) Employs a Unique Drug Rescue Model

VistaGen Therapeutics is a biotechnology company mainly focusing on human pluripotent stem cell (hPSC) technology for drug rescue and regenerative medicine. Human pluripotent cells are the building blocks of all cells of the human body. VistaGen’s versatile stem cell technology platform, “Human Clinical Trials in a Test Tube™,” has been developed to provide clinically relevant predictions of potential heart and liver toxicities of new drug candidates and to enable the company to develop drug rescue variants for once-promising drug candidates. These variants help biotech companies to overcome heart and liver toxicity issues that halted prior clinical trials.

Drug rescue and regenerative is a unique model as VistaGen selects drug candidates that have good future growth prospects but that were abandoned by biotech companies before the approval stage because of their negative effects on the patients’ hearts and livers.

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To create a pipeline of drug rescue variants, VistaGen reworks rejected drug candidates by combining its Human Clinical Trials in a Test Tube platform with contemporary curative chemistry. This will help VistaGen to develop safer drug rescue variants, which will then be sold to biotech companies that will further process and commercialize them. The technology allows the buyer to develop safer drug rescue variants, improve the predictability of a drug’s success or failure, and lower their R&D cost. According to the FDA, 10% improvement in a drug’s failure predictability before commencing its trial studies could save companies around $100 million in R&D costs, helping them to develop new, improved drugs with reduced investment.

Human Clinical Trials in a Test Tube is also expected to achieve faster FDA approval for drug candidates, increasing the biotech company’s bottom line. For developing these variants VistaGen will receive upfront and milestone payments and is eligible for royalties on net sales of these drugs as per their agreement.

Opening doors for future growth

VistaGen with its technological experience designed and developed CardioSafe 3D™, a high throughput, human heart cell-based bioassay. CardioSafe 3D screens heart toxicity in connection with developing drug rescue variants. This will enhance the company’s capability to generate data with its internal validation studies that will allow it to demonstrate more accurate in-vitro prediction of the in-vivo cardiac effects, both toxic and nontoxic, of the new molecules.

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On April 10, VistaGen began collaboration with Cardiac Research Consortium to improve the cardiac safety of medical products as per FDA norms. Along with this the company is also planning to partner with big pharmaceutical and biotechnological companies. VistaGen, with its expertise in developing drug rescue variants, will allow biotech companies to advance their drugs as per FDA norms by improving cardiac safety abilities of new molecules. VistaGen has successfully demonstrated significant development in clinically predictive systems for the preclinical cardiac safety screening of anti-cancer drug candidates with its CardioSafe 3D bioassay. This technology improved the efficacy of new molecules and reduces heart toxicity compared to earlier cancer drugs and other therapeutic compounds. Along with this VistaGen is focusing on developing and validating LiverSafe 3D™, a novel, three-dimensional in-vitro bioassay system that will enable the company to evaluate liver toxicity and drug metabolism issues.

The successful implementation of CardioSafe 3D and Liversafe 3D will allow molecule-developing companies to significantly reduce R&D expenses and earn faster FDA approval. This will in turn strengthen VistaGen financially with an increase in royalties.

Leading its own pain-relieving drug

VistaGen is developing AV-101, a pain reliever drug candidate that it acquired through the acquisition of Artemis Neuroscience in 2003. The company successfully completed phase I development of AV-101 as per the active Investigational New Drug (IND) application filed to FDA for treating neuropathic pain. VistaGen is evaluating the efficacy of this drug in trial studies for treating neuropathic pain, a serious and chronic conditions that causes pain after an injury, and for treating depression, epilepsy, and other neurological conditions. VistaGen’s strategic plans will help it to progress AV-101 to phase II development and enhance its efficacy in treating depression, epilepsy, Huntington’s disease, and Parkinson’s disease. By developing this candidate the company will have greater growth opportunities as neuropathic pain affects around 1.8 million in the U.S. alone. The company has received grants of $8.75 million from the National Institutes of Health (NIH) to develop this drug and receive regulatory approval.

Further, “the safety iceberg model” represents huge underlying opportunities in developing drug rescue variants. VistaGen has a higher future growth opportunity with its hPSC technology, which will enable biotech companies to overcome the weakness related to heart and liver toxicity.

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Conclusion

VistaGen’s hPSC technology platform will enable it to develop drug rescue variants of the promising drug candidate, supporting it financially long-term. Additionally, expanding its product portfolio with AV-101 will support its top line. This unique model developed by the company makes it a good long-term investment.

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