Tuesday, September 8, 2009, 9:35am EDT | Modified: Tuesday, September 8, 2009, 10:14amOsiris suffers another stem cell setbackWashington Business Journal - by Tucker Echols Staff Reporter
Osiris Therapeutics Inc. suffered another setback for plans to commercialize its stem cell drug Prochymal, as the drug proved no better than a placebo in two final trials.
Columbia, Md.-based Osiris Tuesday said preliminary results for two phase III trials evaluating Prochymal for the treatment of acute graft versus host disease showed no statistical difference between the drug and a placebo in either trial. Osiris said Prochymal did show significant improvements in response rates in difficult-to-treat liver and gastrointestinal graft versus host disease even as it failed to meet its primary endpoint in both trials.
Osiris investors were unhinged by the news and sent shares of Osiris down as much as 40 percent. Osiris stock (NASDAQ:OSIR) declined $4.89 to $7.32 at the opening bell of Tuesday trading. The shares then recovered modestly and were down $4.21 to $8 each as of 9:49 a.m.
Graft versus host disease is the most common complication of bone marrow transplantation, and is a life-threatening disease for which there is currently no approved treatment.
“These data are still preliminary and further analysis is needed to gain a full appreciation of the results of these rigorous, double-blind, placebo-controlled trials,” said Osiris CEO C. Randal Mills. “We are encouraged to see Prochymal significantly improve response rates above standard of care in graft versus host disease patients who currently have no good treatment options,” Mills said. “We will meet with the FDA as soon as possible to discuss the most appropriate and efficient path forward.”
The trial failure is the third disappointing result for a Prochymal test this year. In March, the company halted enrollment in a final stage trial of Prochymal as a treatment for Crohn’s disease after noting significantly higher than expected placebo response rates. And in June, Osiris said that a test of Prochymal as a treatment for patients with lung disease showed that the drug significantly decreased inflammation, but did not significantly improve pulmonary function six months into the two-year trial.
Prochymal is a mixture of mesenchymal stem cells made into an intravenous injection. The mesenchymal stem cells used in Prochymal are harvested from the bone marrow of healthy young adult donors and then grown in culture.
According to Osiris, studies suggest mesenchymal stem cells are able to facilitate tissue repair by reducing severe inflammation and working at the cellular level to rebuild damaged tissue through the release of tissue specific growth factors.