Stung with heart safety problems of previous drugs, GlaxoSmithKline ($GSK) has been on the forefront of using an acclaimed discovery in stem cell science to catch cardiovascular risks of compounds prior to human testing, Bloomberg reported. And the London-based drug giant's use of the technology helps the company tackle safety hazards that trigger costly failures in clinical trials.
Glaxo's use of induced pluripotent stem (iPS) cells in lab tests has grabbed headlines after Shinya Yamanaka recently picked up a Nobel Prize in medicine for the breakthrough. Visionaries believe that Yamanaka's discovery, which involves transforming skin cells into multipurpose iPS cells, could eventually lead to human therapies on their own to repair or replace damaged tissues. As Bloomberg reports, GSK and others have tapped the iPS cells to grow heart cells for lab assays, which provide live samples to test whether an experimental drug is likely to cause cardiovascular side effects.
Like many drugmakers, GSK has a lot to gain from the ability to flag heart risks early in an R&D program. Cardiovascular side effects topple many drug candidates in clinical trials, and spotting such problems before human testing could save pharma companies from dumping millions of dollars on clinical studies destined to fail. Also, Glaxo has felt the sting from how cardio problems can doom the prospects of a marketed drug, as in the case of its diabetes therapy Avandia, which was pulled from the market in Europe and is only available on a limited basis in the U.S. over heart risks.
"I call this a low-risk, must-do approach to stem cells," said Jason Gardner, head of GSK's early-stage regenerative medicine research, as quoted by Bloomberg. Gardner told the news service that people ask what the iPS cell-based assays would say about Avandia. Unfortunately, the company started using the stem cell assays in its labs in 2010, long after the FDA approved the diabetes drug. Now the U.S. regulator has been in talks with the company about the effectiveness of the iPS cell assays in testing heart risks.
As he told Bloomberg, Gardner believes that within a couple of years the tests could be used across the industry. Beyond testing drugs on heart cells in a lab dish, the iPS discovery offers options to grow neurons to provide an early glimpse at the potential impact of a drug on the central nervous system.
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