Unexpected cardiotoxicity, which
damages the heart muscles, is among the most prevalent reasons for failure of
both drugs and drug candidates. VistaGen Therapeutics, Inc. (OTCQB: VSTA),
through its customized cellular assay system, CardioSafe 3D™, is working to
enhance current testing practices and dramatically improve clinical
predictability for new drugs.
The company’s CardioSafe 3D™
technology utilizes VistaGen’s human pluripotent stem cell-derived
cardiomyocytes (hPSC-CM) and customized assays to screen for heart
complications of new drug candidates, including cardiomyocyte cytotoxicity and
the development of irregular beating patterns. By incorporating its
groundbreaking system early in preclinical development, VistaGen expects to
decrease development costs by avoiding instances of late-stage clinical
termination and product recall from the market.
With its proprietary human stem cell
differentiation technology, the company is able to generate hPSC-CMs at higher
levels of purity without the need for genetic modification or cell selection,
which can distort results and clinical predictively. VistaGen expects
CardioSafe 3D™ to be effective as both a method of identifying novel drug
candidates with potential cardiotoxicity side effects and a new generation tool
to study important potential mechanisms of cardiotoxicity for drug discovery
and regenerative medicine applications.
According to a report from The
National Center for Biotechnology Information (NCBI), cardiovascular toxicity
remains a major cause of concern for a variety of drug candidates, including
those used to treat various types of cancer, antidepressants, antipsychotics
and antibiotics. Current testing methods, such as live animal models and the
hERG assay, simply can’t provide the far more comprehensive levels of human
biological accuracy needed to prevent potentially costly oversights in drug
development.
NCBI reports that the costs
associated with bringing a new drug to market exceed $1.5 billion, and experts
agree that the cost of research and development, particularly in terms of
clinical trials, is still on the rise. For that reason, it’s imperative for
pharmaceutical companies to use the most accurate tools available in order to
avoid potentially massive financial missteps. VistaGen, through the continued
development and implementation of its CardioSafe 3D™ technology, is creating a
preclinical tool that major pharmaceutical developers and the FDA won’t be able
to ignore.
For more information on the company,
visit www.vistagen.com
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