September 9, 2009
Stem cell drug fails clinical tests
A U.S. drugmaker says its efforts to produce the first drug derived from human stem cells has failed clinical trials.
Osiris Therapeutics of Columbia, Md., announced Tuesday that a pair of clinical trials for its drug Prochymal revealed that it was no more effective than a placebo in treating bone marrow transplant complications, The New York Times reported.
The results dashed hopes that Prochymal could become the first drug mass-produced from human stem cells obtained from the bone marrow of healthy adult donors. The drug was envisioned to be helpful in fighting graft-versus-host disease in bone marrow transplants, in which immune cells in donated marrow recognize the recipient's organs as foreign tissue, the Times said.
Osiris officials said that while the second clinical trial didn't produce the hoped-for results, it did indicate that Prochymal provided a statistically meaningful benefit for graft-versus-host disease patients in treating their affected livers and gastrointestinal tracts.
Prochymal is having a clear effect in the liver, and that is the most underserved patient population, C. Randal Mills, the company's chief executive, told the newspaper.