VistaGen
Therapeutics, a California-based biotechnology company, is addressing the need
to bring effective treatments to market while reducing the time and cost
traditionally needed to do so. By leveraging its Human Clinical Trials in a
Test Tube™, the company is using human pluripotent stem cell technology to
enable biotechnology and pharmaceutical companies to identify unexpected heart
or liver safety concerns before a drug candidate has journeyed far into its
development process. With this “drug rescue” capability, biotechnology and
pharmaceutical companies also become able to renew their approval efforts of
once promising, but currently idle drug candidates that were discontinued due
to heart or liver safety issues.
In a recent
editorial by the Washington Post on new drug development initiatives by the
National Institutes of Health, the cost of drug development failure is daunting
and pervasive within the industry. According to the editorial, “taking a drug
candidate from early discovery through Food and Drug Administration approval
takes a decade and has a 95 percent failure rate.” Plus, with the cost of drug
development being known to be able to exceed $1 billion, it is clear that
pharmaceutical companies face a very uphill challenge in bringing blockbuster,
high-therapeutic-potential drugs to market in today’s “drug approval climate.”
In a Forbes article
from 2012 it states the financial risk associated with a failed drug candidate
for a big pharmaceutical company can be huge. The article notes that the cost
of an average drug developed by a major pharmaceutical company is at least $4
billion. It’s in these environments where the drug rescue potential of VistaGen
Therapeutics’ technology becomes clear. VistaGen Therapeutics believes that
conventionally used toxicological testing systems, such as animal testing and
other nonclinical methods, do not closely approximate human biology enough to
account for initially undetected liver and heart toxicity and metabolism
issues. Human Clinical Trials in a Test Tube™, in contrast, enables the
differentiation of human pluripotent stem cells into mature human cells. With
these resources in hand, therapeutic solution developers are then able to
attempt identification of any emerging liver or heart safety issues before a
drug candidate has generated huge costs in research and development.
Mr. Shawn Singh,
J.D., Chief Executive Officer of VistaGen Therapeutics, has described the
disruptive potential of Human Clinical Trials in a Test Tube™ as
“game-changing.” Having noted that he has not seen anything like the ways
VistaGen Therapeutics is applying stem cell technology in his broad
professional career, Mr. Singh has acknowledged his confidence that the human
pluripotent stem cell technology could change the face—and cost dynamics—of
American drug development and approval.
For more information,
visit: www.vistagen.com
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