COLUMBIA, Md. -- (BUSINESS WIRE) -- Osiris Therapeutics, Inc. (NASDAQ:OSIR) announced today that results from both a pharmacoeconomic evaluation and a scientific characterization (cryopreservation versus non-cryopreservation) of Grafix® will be presented at the 2014 Spring Symposium on Advanced Wound Care (SAWC) in Orlando.
The pharmacoeconomic evaluation study focuses on the economic advantages that Grafix provides using claims data, including discharge information from over 6.9 million patients (DRG Summary for Medicare Inpatient Prospective Payment Hospitals) and clinical data from Osiris’ multi-center, randomized, controlled clinical trial evaluating the safety and effectiveness of Grafix in patients with chronic diabetic foot ulcers (DFU). The trial demonstrated overwhelming efficacy of Grafix when compared to conventional care (62% vs. 21%, p=0.0001). Performed by the Division of Health Care Policy and Research at the University of Colorado Anschutz Medical Campus, the cost benefit study highlights the overall cost savings of healed ulcers versus non-healed ulcers in the DFU trial. Mean cost savings for a healed ulcer was $20,622.00, which represents a 47% cost savings over the course of the 12-week trial compared to non-healed ulcers (p < 0.0138). Additionally, the study demonstrates the advantages of offering multiple graft sizes as 95% of all Grafix patients either healed or were able to use the smallest available graft size at the end of the 12-week trial.
“Treatment costs alone do not reflect the actual costs to the healthcare system when addressing the clinical condition of DFUs. A holistic estimation of costs needs to include patient medications and outpatient procedures, as well as much more expensive inpatient hospitalizations,” said Eugene J. Nuccio, Ph.D., Assistant Professor at the University of Colorado Anschutz Medical Campus. “The cost comparison presented reflects this more comprehensive and inclusive estimation of costs associated with healing vs. not healing a DFU for the patients in the clinical trial.”
The scientific characterization study demonstrates that a cryopreserved human amniotic membrane has enhanced activity relative to a non-cryopreserved human amniotic membrane, for improved wound closure potential. The cryopreservation process is able to effectively protect the natural components of the amniotic membrane, including the three-dimensional tissue matrix architecture, growth factors and cells. In comparison to non-cryopreserved membrane, the cryopreserved membrane demonstrates significantly higher (p<0.005) anti-inflammatory and antioxidant activity. Also, the cryopreserved membrane clearly supports effective cell recruitment and new blood vessel formation compared to non-cryopreserved membrane.
The 27th Symposium for Advanced Wound Care (SAWC) Spring Conference is held from April 23th to 27th. The meeting is the leading wound healing conference in the country and is the official meeting site of the Association for the Advancement of Wound Care (AAWC). Visit Osiris at SAWC Booth 1329.
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 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 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 the Pharmacoeconomic Study
The pharmacoeconomic (PE) study applied a rigorous PE model to the clinical data obtained from Protocol 302 and was designed to compare per patient estimated total health care costs during the trial. Five cost categories were identified including treatment costs based on wound size matched to available graft size, medications using data from the CMS National Average Retail Price (NARP) report, clinical procedures delivered in the outpatient setting, and adverse event, serious adverse events and hospitalizations including discharge information from over 6.9 million patients assigned to specific Diagnosis Related Groups (DRG) using the Agency for Healthcare Research and Quality (AHRQ) DRG Summary for Medicare Inpatient Prospective Payment Hospitals. Trial event data from the 97 participants were combined and evaluated for cost effectiveness.
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® and Ovation® 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. 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, 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)
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