The U.S. Food and Drug
Administration has a low tolerance for drug candidates with safety risks;
countless potential new drugs candidates fail in preclinical or clinical trials
due to safety concerns, costing pharmaceutical companies billions of dollars in
research and development (R&D) costs. VistaGen Therapeutics, a biotech
company applying stem cell technology for drug rescue and cell therapy,
believes that the majority of pricey and unexpected heart and liver toxicity
and metabolism issues is due to limitations of the major toxicological testing
systems currently used in the pharmaceutical industry, such as animal testing
and cellular assays based on transformed cell lines and human cadaver cells.
VistaGen has developed the
Human Clinical Trials in a Test Tube™ to address this problem. The platform
takes human pluripotent stem cells, cells that have the ability to be geared
and developed into any other kind of cell in the human body, and differentiates
them into useable human heart cells and human liver cells. The company’s goal
is to pair its stem cell technology with modern medicinal chemistry to create a
diverse drug pipeline consisting of new, proprietary, small molecule variants
(drug rescue variants) of once-promising drug candidates.
Upon developmental success,
each lead drug rescue variant has potential to be a new drug candidate through
which VistaGen can have upfront and development milestone payments and
royalties on commercial sales. For big pharma companies struggling to roll-out
new drugs, VistaGen’s technology offers an incredible solution.
Take Pfizer, for example.
The company cut its R&D costs by $800 million to $6.6 billion last year to
offset lagging revenues. In a recent article published on FierceBiotech.com,
author John Carroll writes that while Pfizer expects to spend between $6.4
billion – $6.9 million on this year’s R&D, there’s speculation the company
is capable of developing new blockbuster products. In 2013, Pfizer received FDA
approval for Duavee, for hot flashes caused by menopause. Carroll also notes
while the company received numerous FDA approvals in 2012, revenues continued
to disappoint.
In conclusion, Carroll
writes of Pfizer, “… there’s no convincing sign that the pharma giant has
figured out how to get more out of the multibillion-dollar research budget that
remains.”
According to the Food and
Drug Administration even only a 10 percent improvement in predicting failure
before clinical trials could save $100 million in development costs, which for
a company in Pfizer’s position would allow for maximum use of R&D funds
before digging too deep into the budget. VistaGen’s Human Clinical Trials in a
Test Tube™ has been developed to provide clinically relevant predictions of
potential heart and liver toxicity of promising new drug candidates long before
they are ever tested on humans.
By more closely
approximating human biology than conventional animal studies and other
nonclinical techniques and technologies currently used in drug development,
VistaGen’s human stem cell-based bioassay systems can improve the
predictability of the drug development cycle and lower the cost of new drug
research and development by identifying product failures earlier in the cost
curve.
For more information, visit
www.vistagen.com
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