Osiris Announces Top-Line Interim Results for Stem Cell Trial for Knee Repair Monday February 12, 6:02 pm ET
[They were founded to find ways to repair the meniscus (and help cartilage.) This PR does not look promising, which is too bad given all the aging knees out there.]
>...BALTIMORE--(BUSINESS WIRE)--Osiris Therapeutics, Inc. (NASDAQ:OSIR - News) announced six-month interim results in its evaluation of CHONDROGEN(TM) for the regeneration of meniscus in the knee. A total of 55 patients were treated in the Phase I/II, double-blind study evaluating the safety and exploratory effectiveness of CHONDROGEN, a preparation of adult stem cells formulated for direct injection into the knee. At the six month time point, CHONDROGEN met its primary endpoint, demonstrating product safety. The trial did not demonstrate that CHONDROGEN resulted in a statistically significant increase in the volume of meniscus as compared to placebo; however, an improvement in baseline cartilage and joint condition was noted in patients treated with the stem cell drug that was not seen in patients that received placebo. An interim review of the data will be presented by C. Thomas Vangsness Jr., M.D. at the Stem Cell Summit in San Diego on February 13, 2007...
...An initial review of the data showed that CHONDROGEN was well tolerated, was not associated with serious adverse events, did not result in any adverse hematological events, and did not result in the formation of any unwanted or ectopic tissue. There was no significant change in the volume of meniscus on MRI at 6 months in patients that received CHONDROGEN compared to those patients receiving placebo. However, about 30% of patients treated with CHONDROGEN demonstrated an improvement in their baseline cartilage or joint condition, while no patients in the placebo group demonstrated similar improvement.
"Although we are very pleased to see that our stem cells continue to be well tolerated, we are obviously disappointed that we were unable to detect significant amounts of meniscal regeneration," said C. Randal Mills, Ph.D., President and CEO of Osiris Therapeutics. "Presently, we are working to complete our review and fully evaluate the entirety of the data we have received. Moving forward, we await the cartilage data from the one year time point and will investigate further the improvements observed in the pre-existing cartilage damage..."<
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