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Osiris completes enrollment in adult mesenchymal stem cell trial to treat pulmonary disease.

Osiris Therapeutics, Inc., Columbia, MD, announced it has completed enrollment in a human clinical trial designed to evaluate Prochymal, the company's proprietary formulation of adult human mesenchymal stem cells, for treatment of severe Chronic Obstructive Pulmonary Disease (COPD). A total of 62 patients were enrolled in the Phase II trial at six sites in the US.

The company says the double-blind, placebo-controlled study is evaluating safety and efficacy of Prochymal in conjunction with the standard of care for improving pulmonary function in patients with moderate to severe COPD. Patients were randomized to receive either Prochymal or placebo at a 1.1 ration. Measurements used in the trial to detect potential improvements in subjects treated with the drug include pulmonary function tests, exercise capability, and quality of life assessments. In addition, exacerbations and hospitalizations due to COPD will be monitored for both safety and efficacy. Patients will be evaluated over the course of two years following initial Prochymal or placebo infusion.

Osiris says Prochymal is currently being evaluated in three double-blind, placebo controlled Phase III studies, including steroid refractory Graft vs. Host Disease (GvHD) and Crohn's disease. The drug has been granted fast track status by the FDA for all three of the indications. In addition, the drug has obtained Orphan Drug status for GvHD by the FDA and the European Medicines Agency.

Contact: Web site: www.Osiris.com
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Publication:Transplant News
Article Type:Clinical report
Date:Oct 1, 2008
Words:228
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