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
About QualityStocks
QualityStocks is committed to connecting subscribers with companies that have huge potential to succeed in the short and long-term future. We offer several ways for investors to find, evaluate, and learn more about investing in these companies.
QualityStocks is committed to connecting subscribers with companies that have huge potential to succeed in the short and long-term future. We offer several ways for investors to find, evaluate, and learn more about investing in these companies.
Sign up for “The QualityStocks Daily Newsletter” at www.QualityStocks.net
The Quality Stocks Daily Blog http://blog.qualitystocks.net
The Quality Stocks Daily Videos http://videocharts.qualitystocks.net
The Quality Stocks “Ones to Watch” http://gotstocks.qualitystocks.net
Please see disclaimer on the QualityStocks website: http://disclaimer.qualitystocks.net
No comments:
Post a Comment