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Osiris Therapeutics, Inc. (NASDAQ: OSIR), announced today that data from seven studies will be presented at the 2013 Fall Symposium on Advanced Wound Care (SAWC) in Las Vegas. The information presented will range from basic mechanistic science through human clinical trials.
The healing potential of Grafix® will be described in three of the abstracts by comparing the angiogenic, anti-inflammatory, and antioxidant effects of the cellular repair matrix to those of acellular human repair matrices (LB-136, LB-137 and LB-138). Additionally, four studies detailing the results of Grafix in various clinical settings will be presented, including the treatment of diabetic foot ulcers, venous leg ulcers and chronic wounds in patients undergoing long-term treatment with corticosteroids (CS-054, CS-060, CS-061 and Session 1 – Presentation).
“Osiris has been conducting cutting edge research in cell therapy for more than 20 years, providing us with scientific insight that no other company in the space can match,” said Michelle LeRoux Williams, Ph.D., Chief Scientific Officer. “Our deep understanding of the science enables us to offer our physicians and patients the highest quality products, tested to the most rigorous standards and designed to achieve the best possible outcomes.”
The conference will feature a podium presentation by Dr. Larry Lavery, Principal Investigator for the recent Grafix trial and Professor of Plastic Surgery at the University of Texas Southwestern Medical Center. Dr. Lavery will discuss the primary and secondary endpoints and key safety data from Protocol 302, a multi-center, randomized, controlled clinical trial evaluating Grafix for the treatment of diabetic foot ulcers.
th Symposium on Advanced Wound Care Fall 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). Visit Osiris at SAWC Booth 422.
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.
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.