Each year, the U.S.
pharmaceutical industry invests billions of dollars in research and development
of novel drugs, but many drugs never reach the final stage of FDA approval. For
the pharmaceutical companies engaging in the R&D efforts, that results in
sunk costs of billions in investments, “wasted” decades of research and
development efforts, and back-shelved drug candidates that might have been
shown to have great therapeutic potential.
VistaGen
Therapeutics, a biotechnology company, believes that many of these drug
candidates’ failures are attributable to failure costs associated with
unexpected heart and liver safety issues. Moreover, the heart and liver safety
issues may be tied to scientific limitations placed upon drug safety testing by
industry-standard toxicological testing systems, namely animals and cellular
assays based on transformed cell lines and human cadaver cells.
A Forbes article by
Bernard Munos highlights that 27 novel drugs obtained FDA approval this year,
down from 37 drug approvals in 2012. Likewise, VistaGen Therapeutics notes that
since 2003, the FDA has approved fewer than 26 new drugs per year. Industry
statistics notably show that around one-third of all prospective drug
candidates fail in preclinical or clinical development due to the rise of
sudden, unexpected safety issues.
VistaGen
Therapeutics leverages a proprietary stem cell technology, Human Clinical
Trials in a Test Tube™, to make clinical predictions of the toxicities of new
drug candidates possible long before they reach human testing. The company’s
human pluripotent stem cell-based systems are better suited for human biology
approximation than today’s industry-standard toxicological testing systems and
other methods of testing in drug R&D.
The technologies
behind Human Clinical Trials in a Test Tube™ allow for human pluripotent stem
cells to be differentiated into mature human cells for VistaGen Therapeutics’
various cell therapy programs and market opportunities. By detecting human
toxicity or metabolism earlier in testing than usual, the technology enables
pharmaceutical companies to redirect or reconstitute their efforts without the
steep price tag of lost time and money associated with later drug approval
failure.
More information
about VistaGen Therapeutics, its technology, and its progress can be found at:
www.vistagen.com
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