Grafix® Manuscript From Osiris Therapeutics, Inc. (OSIR)’ Multi-Center, Randomized, Controlled Clinical Trial Accepted In Peer-Reviewed Journal
6/19/2014 10:19:53 AM
COLUMBIA, Md.--(BUSINESS WIRE)--Osiris Therapeutics, Inc. (NASDAQ:OSIR), announced today that the manuscript from its multi-center (n=20), randomized, controlled clinical trial comparing the safety and effectiveness of Grafix® to control in patients with chronic diabetic foot ulcers (DFUs) has been accepted for publication in the International Wound Journal. The peer-reviewed journal will report findings from Osiris’ trial, Protocol 302, which demonstrated the overwhelming efficacy of Grafix compared to control in the closure of DFUs over 12 weeks (62% vs. 21.3%, p=0.0001, n=97). Entitled “The Efficacy and Safety of Grafix for the Treatment of Chronic Diabetic Foot Ulcers: Results of a Multicenter, Controlled, Randomized, Blinded, Clinical Trial”, the publication will also highlight the trial’s secondary endpoints – all of which showed statistically significant improvements for patients treated with Grafix compared to control. Grafix was not only favored in time to wound closure (42 days vs. 70 days, p=0.019), number of treatment applications (6 vs. 12, p=0.0001) and probability of wound closure by 12 weeks (67.1% vs. 27.1%, p<0.0001) but also in important safety endpoints including number of patients with adverse events (44% vs. 66%, p=0.031) and wound related infections (18% vs. 36.2%, p=0.044). The publisher expects the electronic publication to be available in July, with the hard copy to follow.
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