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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Please see disclaimer on the MissionIR website http://www.missionir.com/disclaimer.html
