Such late-stage withdrawals represent a huge loss for the pharmaceutical industry, and pose significant risks to early users of such drugs. Unfortunately, current drug testing methods have important limitations in their ability to predict cardiotoxicity in human users. 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, and/or of non-cardiac lineage, or focused on effects relating to a single cardiac ion channel. Such methods yield both false positive and false negative results. What is needed is an accurate early-stage identification of potential cardiotoxicity, one of the key stem cell technology applications which VistaGen’s Human Clinical Trials in a Test Tube™ platform now offers.
Through the use of advanced stem cell technology, VistaGen has produced functional human heart cells that express ion channels and auxiliary proteins relevant to the accurate evaluation of cardiac effects of new drug candidates. Most recently, VistaGen has made major progress in the validation of its human stem cell-derived “Micro-Heart” cardiotoxicity bioassay system, CardioSafe 3D™.
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. Tests showed that the system is highly reproducible, and has a strong concordance with the in-vivo cardiac effects of multiple classes of compounds.
VistaGen has developed a versatile stem cell technology platform based on the controlled differentiation of human pluripotent stem cells into mature, non-transformed cells, which can be used to create novel bioassay systems for predictive toxicology, drug discovery, drug rescue, and cell therapy applications.
For additional information, visit the company’s website at www.VistaGen.com
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