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Osiris Therapeutics Inc. (OSIR) shares fell nine percent to $18.71 on February 13 morning trade after the Baltimore-based company announced mixed results on February 12 for its six-month interim evaluation of Chondrogen for the regeneration of meniscus in the knee, according to a MarketWatch report.
The company said Chondrogen met its primary endpoint.
However, the Phase I/II trial did not demonstrate that Chondrogen resulted in a statistically significant increase in the volume of meniscus as compared to placebo.
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, the company said.
At the six month time point, Chondrogen met its primary endpoint, demonstrating product safety.
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 was presented by C. Thomas Vangsness Jr., M.D. at the Stem Cell Summit in San Diego on February 13.
The study was designed to assess the safety of an injection of stem cells into the joint capsule and to gain preliminary efficacy data on the extent of tissue regeneration using magnetic resonance imaging or MRI.
Patients in the study underwent standard meniscectomy surgery to remove torn or damaged tissue in their meniscus.
One week following surgery, the patients were given a single injection of either placebo, or a low dose (50 million cells) or high dose (150 million cells) of Chondrogen.
Neither the patients nor the surgeons will know what was given for the duration of the study.
Patients will be followed for safety and additional preliminary efficacy, such as pain, cartilage damage, and changes in the meniscus for two years under the current study protocol.
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 percent 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 CEO C. Randal Mills. “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.”
The Chondrogen trial is one of four different clinical trials Osiris currently has active in the United States.
The company has an ongoing Phase III trial evaluating Prochymal for Graft vs. Host Disease, a life threatening complication of bone marrow transplantation, has just initiated a Phase III trial evaluating Prochymal for Crohn’s disease, and has a Phase I trial evaluating Provacel for the repair of heart tissue following a heart attack.
The company said that 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.
Contact: http://www.osiristx.com
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