VistaGen Therapeutics, a biotechnology company applying stem cell technology for drug rescue, predictive toxicology, and drug metabolism assays, recently delivered an overview of key developments involving its CardioSafe 3D™ and LiverSafe 3D™ bioassay systems in poster presentations at the 11th Annual Meeting of the International Society of Stem Cell Research (ISSCR), the largest forum for stem cell and regenerative medicine professionals from around the world, held last week in Boston, Massachusetts.
Dr. Hai-Qing Xian, Senior Scientist, presented VistaGen's poster entitled "Cardiotoxicity Assessment of Anti-Cancer Kinase Inhibitors using Human Pluripotent Stem Cell-Derived Cardiomyocyte Based Assays," which detailed important developments demonstrating that CardioSafe 3D™, VistaGen's high throughput, human heart cell-based bioassay, is a clinically predictive system for preclinical cardiac safety screening of anti-cancer drug candidates, including small molecule kinase inhibitors (KIs), a new category of drugs that have revolutionized cancer therapy due to decreased systemic toxicity and increased target cell efficacy compared to classic cancer drugs, as well as other therapeutic compounds. VistaGen also demonstrated the utility of CardioSafe 3D™ to detect cardiac toxicities of well-known anti-cancer KIs, including imatinib, dasatinib, sunitinib, erlotinib, and temsirolimus, which have been associated with adverse clinical cardiac events that were not detected during the drug development process. As demonstrated in the poster presentation, CardioSafe 3D™ successfully detected cardiotoxicity induced by representative compounds from different KI categories. Additionally, the bioassay system provided clues to the major mechanisms of cardiac cytotoxicity induced by each compound, thus enabling not only the identification of toxicities early in the drug development process, but also discovery of potential mechanisms of action.
Dr. Kristina Bonham, Senior Scientist, Hepatocyte Biology Project Leader, presented VistaGen's poster entitled "Semi-quantitative assay of CYP3A4 allows the identification and selection of mature human stem cell derived hepatocytes," which detailed developments indicating that LiverSafe 3D™, VistaGen's human liver cell-based bioassay, can monitor the induction of the key metabolic enzyme, CYP3A4, and its expression level over time. Using an optimized protocol for the differentiation of hepatocyte-like cells, VistaGen demonstrated levels of CYP3A4 mRNA approaching that in human adult liver on a per cell basis. The reported data suggest that VistaGen's liver cells have many of the functional properties of mature adult liver cells, enabling multiple functional analyses and providing a powerful system to evaluate the effects of drug candidates on CYP3A4 expression and liver function, offering a valuable aid for assessing potential drug candidates for toxicity and adverse drug-drug interactions.
H. Ralph Snodgrass, PhD, VistaGen's President and Chief Scientific Officer, emphasized, "For the first time, our technology has caught up with the dreams and visions we had 15 years ago when we founded VistaGen. We now have the type and quality of human cell-based biological assay systems that provide real insight into both the therapeutic and toxic effects of new drug candidates long before they are ever tested in humans. Next-generation biological assays can now provide important preclinical human data that will increase the probability of selecting safer and effective therapeutics for clinical development."
"It is evident from the mood, tone and scientific discussions throughout the ISSCR conference that this is the most exciting time in the history of stem cell research," added Dr. Snodgrass. "We anticipate that we will see an explosion over the next ten years in the contribution of human pluripotent stem cell-based biological assays to drug development, in parallel with phenomenal advancements in the therapeutic uses of mature cells and tissues derived from human pluripotent stem cells to treat some of the most intractable human diseases and conditions. Our team is truly fortunate and excited about being a part of this transformational process."
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