National Institute of Health’s Focus on Drug Rescue to BenefNational Institute of Health’s Focus on Drug Rescue to Benefit VistaGen Therapeutics (VSTA)
VistaGen Therapeutics is a 16-year-old biotechnology company that uses human pluripotent stem cell (hPSC) technology to devise a new platform for new drug development with a core focus on drug rescue. Their commercial platforms consist of bioassay systems. Essentially, bioassay refers to that portion of medical research that involves testing the biological activity of a substance by usage of a live animal (in vivo) or living human tissue or cells (in vitro). Pluripotent stem cells are undifferentiated human cells that can be artificially grown and transformed into specific cells such as liver cells, red blood cells, heart muscle cells, and so forth.
VistGen Therapeutics products, CardioSafe 3D and LiverSafe 3D, are their platforms using stem cell technologies to fulfill the bioassay portion of new drug development so one doesn’t have to involve live animal testing while getting better measurable results to determine the toxicity of a newly tested drug on heart and liver cells. In fact, VistaGen Therapeutics has specifically branded this package of products under the trademarked name of Human Clinical Trials in a Test Tube.
Drug rescue refers to drugs or the components of drugs, such as small molecules and biologics, that were rejected during clinical trials. VistGen Therapeutics will initially focus on therapies that were abandoned due to heart and liver toxicity.
Although over the past decade, the government’s basic research and development budget has been slashed by 25%, there was restructuring with the National Institute of Health (NIH) to accelerate drug development with the introduction of the new National Center for Advancing Translational Sciences (NCATS) with a budget of $575 million. NCATS has a focus on accelerating new drug development, drug rescue as well as drug repurposing. Drug repurposing refers to research on already approved small molecules and biologics for new indications and disease treatments.
The lobby for the large-cap pharmaceutical manufacturers such as Johnson & Johnson, Pfizer, Roche, and others, known as the Pharmaceutical Research and Manufacturers of America (PhRMA), have aggressively lobbied the administration and congress regarding what they consider to be the exploding costs of new drug development and a high failure rate. The industry has been citing costs varying from $350 million to $5 billion per new drug developed.
However, that’s quite controversial, as academics and nonprofits point out. Well over half the costs for new drug development is funded by the taxpayers with basic research done in universities or federal government labs. A good example is the $484 million the federal government spent on the development of cancer drug Taxol, which was licensed to Bristol Meyers Squibb. The pharmaceutical giant made well over $9 billion in worldwide sales and yet the total royalty received by the NIH was $35 million. Another example, NIH researcher Julius Axelrod won the Nobel Prize in Physiology or Medicine in 1970 for his fundamental discoveries about neurotransmitters; later, companies like Eli Lilly & Co., Pfizer and SmithKline Beecham built on that work to develop the class of antidepressants known as selective serotonin-reuptake inhibitors, including Prozac, Zoloft and Paxil. Basically, estimates of the true costs to the large drug manufacturers is anywhere from $48 to $55 million for new drug development, with the rest of the costs actually going to the taxpayers who do not realize a fair return on investment.
The formation of NCATS and the focus on drug rescue was most likely seen as a compromise to aid both private sector and public sector researchers. PhRMA is considered a highly influential lobby and typically spends anywhere from $18 million to $20 million on political campaign contributions.
In regards to new drug development, stem cell technology is viewed as a newer and safer way to begin testing new pharmaceuticals. VistaGen Therapeutics wisely has focused drug rescue, which is the current emphasis of the NIH and the pharmaceutical industry, meaning there is ready demand for its patented technology platform.
For more information, please visit www.vistagen.com.
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