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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