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 about
the company visit www.vistagen.com
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