Press release from Business Wire
Grafix® Diabetic Foot Ulcer Clinical Trial Accepted for Presentation at the 2013 Symposium on Advanced Wound Care
Thursday, September 05, 2013
Grafix® Diabetic Foot Ulcer Clinical Trial Accepted for Presentation at the 2013 Symposium on Advanced Wound Care16:11 EDT Thursday, September 05, 2013
COLUMBIA, Md. (Business Wire) -- 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 26th Symposium on Advanced Wound Care Conference is held from September 27th to 29th. 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 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.
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 BioSmartTM 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)
This press release contains forward-looking statements. Forward-looking statements include statements about our expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Words or phrases such as "anticipate," "believe," "continue," "ongoing," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project" or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Examples of forward-looking statements may include, without limitation, statements regarding any of the following: our product development efforts; our clinical trials and anticipated regulatory requirements, and our ability to successfully navigate these requirements; the success of our product candidates in development; status of the regulatory process for our biologic drug candidates; implementation of our corporate strategy; our financial performance; our product research and development activities and projected expenditures, including our anticipated timeline and clinical strategy for mesenchymal stem cells and biologic drug candidates and marketed Biosurgery products (including Prochymal, Chondrogen®, Grafix, Ovation and Cartiform); our cash needs; patents, trademarks and other proprietary rights; the safety and ability of our products and potential products to treat disease; our ability to supply a sufficient amount of our marketed products or product candidates and, if approved or otherwise commercially available, products to meet demand; our costs to comply with governmental regulations; our plans for sales and marketing; our plans regarding facilities; types of regulatory frameworks we expect will be applicable to our products and potential products; and results of our scientific research. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. Our actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the section entitled "Risk Factors" in our Annual Report on Form 10-K and other Periodic Reports filed on Form 10-Q, with the United States Securities and Exchange Commission. Accordingly, you should not unduly rely on these forward-looking statements. We undertake no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this press release or to reflect the occurrence of unanticipated events.
Osiris Therapeutics, Inc.
Aziz Ahmad, 443-545-1834