In a recent poster presentation given at the fourth Symposium on Cardiovascular Regenerative Medicine hosted by the National Institutes of Health’s National Heart, Lung and Blood Institute, VistaGen Therapeutics, a biotechnology company applying human pluripotent stem cell technology for drug rescue and cell therapy, described research and development activities focused on validation of CardioSafe 3D™, its human stem cell-derived “Micro-Heart” cardiotoxicity bioassay system.
The presentation, given by Dr. Ralph Snodgrass, VistaGen’s President and Chief Scientific Officer, revealed the advances in predictive toxicology and drug safety screening being driven by the company’s versatile pluripotent stem cell technology platform. Current methods for measuring the potential toxicity of drug candidates are inadequate, often producing false positive or negative results, which in turn leads to costly project terminations during clinical development. Traditional evaluation methods depend upon animal testing, although animals respond differently than humans to many drugs, or on cell lines that are engineered, transformed, non-human, of non-cardiac lineage, or focused on effects on a single cardiac ion channel. Both approaches are unreliable because they inadequately match end-user biological conditions.
Human pluripotent stem cells avoid these problems by permitting the production of functional human cardiac cells that express ion channels and auxiliary proteins relevant to the accurate evaluation of cardiac function and possible long-term cardiac abnormalities. The presentation describes the work of VistaGen and collaborating scientists, and its validation of the company’s cardiotoxicity bioassay system. The system was validated by measuring the dose-dependent effects on cardiomyocyte cell viability and electrophysiological responses, as measured by patch clamp and field potential assays, of twelve compounds with known cardiac cytotoxicity or electrophysiology effects. The data described showed that the system is highly reproducible with very strong concordance with the in-vivo cardiac effects of multiple classes of compounds.
VistaGen CSO, Dr. Ralph Snodgrass, described the significance of the VistaGen cardiotoxicity assay. “Cardiotoxicity has been implicated in almost 30% of drug withdrawals in the United States over the last 30 years. Our human stem cell-derived ‘Micro-Heart’ cardiotoxicity assay, CardioSafe 3D™, will contribute to the efficient and rapid identification of safer drugs before valuable resources are lost developing drug candidates with toxicity issues that are undetected until human clinical trials are in progress or even after FDA approval resulting in withdrawal from the market.”
The complete abstract of the presented poster has been made available by the Drug Safety Executive Council (DSEC), which has a membership of over 2,000 pharma safety professionals, at the following link: www.chicorporate.com/dsec_poster_list.aspx. Investors can also find the complete abstract by visiting the investors section of the VistaGen website at www.VistaGen.com
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