With diseases such as
Alzheimer’s, type 2 diabetes, and rheumatoid arthritis on the rise, there is a
growing need for new and more effective treatments. But as an editorial by the
Washington Post on new drug development initiatives by the National Institutes
of Health makes clear, the cost of drug development failure is staggering—and
widespread. 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”.
VistaGen Therapeutics, a
California-based biotechnology company, meets this problem head-on with its
Human Clinical Trials in a Test Tube™, a human pluripotent stem cell technology
that enables 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 bring-to-approval
efforts of once-promising-but-now-backshelved drug candidates that were
discontinued due to heart or liver safety issues.
According to a Forbes
article in 2012, the sunk cost of 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. That is 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 then become able to identify any emerging
liver or heart safety issues before a drug candidate has generated huge sunk
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
signified 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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MissionIR is committed to connecting the investment community with companies that have great potential and a strong dedication to building shareholder value. We know our reputation is based on the integrity of our clients and go to great lengths to ensure the companies represented adhere to sound business practices.
Sign up for “The Mission Report” at www.MissionIR.com
