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
Let us hear your thoughts:
