VistaGen’s human pluripotent
stem cell (hPSC) based approach to salvaging the massive outlays that are
otherwise eaten when a once-promising drug candidate is dropped due to
unexpected heart or liver toxicity complications (or preemptively preventing
such losses), using their proprietary Human Clinical Trials in a Test Tube™
platform to accurately model the effects and develop safer Drug Rescue
Variants™, also happens to be extremely useful for modeling non-toxic effects
and thus represents a framework technology for drug development unlike anything
which has come before it. The core component of this platform, an in-vitro
bioassay system that utilizes functional/mature human heart cells derived from
hPSCs to create three dimensional cardiac tissues, known as CardioSafe 3D™, is
designed to be vastly more precise and expedient than extant surrogate safety
models.
VistaGen recently reported
(Apr 10) some big news in this area that will no doubt lead to key partnerings
in future, as the company has become a member of the renowned public-private
medical product cardiac safety research organization, the Cardiac Safety
Research Consortium (CSRC), which was created back in 2006 via the FDA’s
Critical Path Initiative MoU with Duke University. Since inception, the CSRC
has come to be known as a driving force in public health and cardiac safety
among the wide range of academic, governmental, and industrial stakeholders in
the biopharma space which it engages in the support of these ends.
President of VSTA and the
company’s CSO, Ralph Snodgrass, Ph.D., underscored the significance of mounting
cardiac safety concerns associated with new drug candidates and the importance
of identifying complications prior to human studies, further emphasizing that
these concerns are the very internal mechanism which drives VSTA itself.
Snodgrass also pointed to the key area of proarrhythmia safety, a serious and
not infrequent complication in antiarrhythmic drugs where they actually provoke
new arrhythmia (or a marked spike in the frequency of a preexisting
arrhythmia), as being a primary target. Professor of Medicine at Duke and CSRC
Co-Chair, Mitchell Krucoff, MD, FACC, hailed the start of a long and productive
relationship with VSTA, noting the company’s commitment to proactive cardiac safety
and how their membership strengthens the CSRC as well.
VSTA has winning technology
here, with their ability to create a 3D bioassay that can be used to rapidly
assess and benchmark new drugs, offering levels of detail and accuracy that
make existing animal models or mere in-vitro cell culture approaches look like
the antiquated technologies that they really are. The long-term potential for
VSTA to prove up Drug Rescue Variants is enhanced by being able to make
strategic connections through the CSRC membership and this relationship will
help throw a spotlight on the compelling advantages of the company’s technology
for predictive toxicology and drug metabolism assays, in addition to drug
rescue.
Alongside CardioSafe 3D™,
VSTA has developed a second major Human Clinical Trials in a Test Tube
component, LiverSafe 3D™, designed to test drug-drug interactions and provide
the same kind of over-the-horizon radar system for liver toxicology. In light
of prior CardioSafe 3D™ developments regarding its use as a clinically
predictive system for assessing cardiac toxicity in anti-cancer drugs,
especially the revolutionary new small molecule kinase inhibitors which have
drawn criticism (despite other benefits) for causing cardiac events not
detected during drug development, this latest news about the CSRC membership is
very bullish for VSTA and investors should keep an eye on the company as the
broader biotech sector trims.
More info on this pioneering
biotech developer is available at www.VistaGen.com
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