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.
“Our diabetic foot ulcer patients have an exciting treatment option with Grafix, as this multi-center trial represents the first successful multi-center trial in this space in over a decade,” said Dr. Larry Lavery, lead author and Professor of Surgery at the University of Texas Southwestern. “Major multi-center trials like this are the highest form of evidence and eliminate the bias seen in smaller, single center studies. Wound closure can be difficult, and Grafix demonstrated a relative improvement of 191% over control – the highest reported among wound care products tested in similarly rigorous trials.”
In the trial, patients were randomized to receive Grafix or control, which included debridement, a non-adherent dressing, and standardized off-loading. Patients were followed weekly for up to 12 weeks during the treatment phase. Patients that received control and did not heal within 12 weeks were able to receive Grafix in an open-label crossover arm of the trial for up to 12 additional weeks. In patients participating in this crossover phase, Grafix closed 66% of wounds in a median time of 42 days.
“This trial highlights Osiris’ commitment to providing sound clinical data to support the science behind our innovative products,” said Lode Debrabandere, Ph.D., President and Chief Executive Officer of Osiris. “We are pleased that the manuscript has been accepted for publication, and we want to thank all of the investigators, institutions, and patients that participated in our trial.”
About the Trial (Protocol 302)
Protocol 302 is a single-blind, randomized, controlled multi-centered trial evaluating the efficacy and safety of weekly applications of Grafix for the treatment of chronic diabetic foot ulcers. A total of 97 patients were enrolled at 20 leading wound care centers across the United States. Patients between 18 and 80 years of age with confirmed type 1 or type 2 diabetes and chronic diabetic foot ulcers on the dorsal or plantar surface of the foot were randomized to Grafix or control at a 1:1 ratio. Ulcers had to be present for at least 4 weeks prior to randomization and be between 1 cm2 and 15 cm2 in size. Patients were excluded from the trial if the ulcer decreased with more than 30% during the one week screening period. Patients received treatment weekly for up to 12 weeks. The primary endpoint measures complete wound closure by 12 weeks as determined by the investigator and confirmed by an independent, blinded Wound Core Lab. Secondary endpoints include complete wound closure rates for those patients that complete all scheduled treatments, time to wound closure, number of applications and adverse events, including reduction in infections. Patients randomized to control, who did not heal within 12 weeks, entered a cross-over arm for evaluation in an additional 12 week open-label treatment with Grafix.
About Grafix
Grafix is a cryopreserved placental membrane for acute and chronic wounds. It is a flexible, conforming membrane that is applied directly at the site of the wound. Grafix is produced by Osiris’ BioSmartTM Intelligent Tissue Processing which maintains the integrity of the extracellular matrix, growth factors, and endogenous fibroblasts, epithelial cells and mesenchymal stem cells of the native tissue.
About Osiris Therapeutics
Osiris Therapeutics, Inc. is the leading stem cell company, having developed the world’s first approved stem cell drug, remestemcel-L for graft versus host disease. Osiris’ products include Grafix, a cryopreserved placental membrane for acute and chronic wounds, Cartiform®, a viable cartilage mesh for cartilage repair and the latest addition to Osiris’ line of products, OvationOS®, a viable bone matrix for bone repair and regeneration. Osiris is a fully integrated company with capabilities in research, development, manufacturing and distribution. Osiris has developed an extensive intellectual property portfolio to protect the company's technology and commercial interests.
Osiris, Grafix, Cartiform and OvationOS are registered trademarks of Osiris Therapeutics, Inc. More information can be found on the company's website, www.Osiris.com. (OSIR-G)
Forward-Looking Statements
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Contacts:
Aziz Ahmad, 443-545-1834
OsirisPR@Osiris.com
