Osiris Therapeutics, Inc. (NASDAQ: OSIR), announced today that its multi-center, randomized, controlled clinical trial evaluating the safety and effectiveness of Grafix ® for the treatment of chronic diabetic foot ulcers has been accepted for podium presentation at the upcoming Symposium on Advanced Wound Care (SAWC) in Las Vegas on Friday, September 27, 2013. Dr. Larry Lavery, Principal Investigator and Professor of Plastic Surgery at the University of Texas Southwestern Medical Center, will discuss the primary and secondary endpoints as well as additional key safety data from the trial.
In August, Osiris reported that the trial had reached the pre-specified stopping rules for overwhelming efficacy. 62% of patients receiving Grafix achieved complete wound closure compared to only 21% (p<0.0001) of patients receiving conventional treatment. Additionally, the trial demonstrated that Grafix closed wounds faster and required fewer treatments, with fewer adverse events than standard treatment.
The 26 th Symposium on Advanced Wound Care Conference is held from September 27 th to 29 th. The meeting is the largest wound care conference in the country and is the official conference of the Association for the Advancement of Wound Care (AAWC).
About the Trial (Protocol 302)Protocol 302 is a single-blind, randomized, controlled multi-center trial evaluating the efficacy and safety of weekly applications of Grafix for the treatment of chronic diabetic foot ulcers. A total of 131 patients were enrolled at 19 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 dressings at a 1:1 ratio. Ulcers had to be present for at least 4 weeks prior to randomization and between 1 cm 2 and 15 cm 2 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 are confirmed using 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, proportion of patients achieving at least a 50% reduction in wound size by day 28 and number of re-occurrences. Patients randomized to the control group 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 human cellular repair matrix containing living stem cells for acute and chronic wound repair. It is a flexible, conforming membrane that provides a high quality source of living mesenchymal stem cells (MSCs) and growth factors directly to the site of the wound. Grafix is produced by BioSmart TM Intelligent Tissue Processing of human placental membrane. The manufacturing process maintains the integrity of the extracellular matrix, the viability of the neonatal MSCs, and the biologically active growth factors. About Osiris Therapeutics Osiris Therapeutics, Inc., is the leading stem cell company, having developed the world’s first approved stem cell drug, Prochymal ®. Osiris currently markets Grafix and Ovation ® for wound and tissue repair, and Cartiform ® for cartilage repair. Osiris is a fully integrated company with capabilities in research, development, manufacturing and distribution of cell therapy products. Osiris has developed an extensive intellectual property portfolio to protect the company's technology, including 51 U.S. and 162 foreign patents. Osiris, Prochymal, Chondrogen, Grafix, Ovation and Cartiform 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 This press release contains forward-looking statements. 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