Grafix® Manuscript Reporting Positive Outcomes of Multicenter Chronic Complex Wounds with Exposed Tendon and Bone Clinical Trial is Available Electronically in Peer-Reviewed Journal
COLUMBIA, Md., Aug. 04, 2016 (GLOBE NEWSWIRE) — Osiris Therapeutics, Inc. (NASDAQ:OSIR), a leading cellular regenerative medicine company focused on developing and marketing products to treat conditions in wound care, orthopaedics and sports medicine, announced today that the manuscript from its multicenter prospective post-market clinical trial using Grafix was accepted for publication in the International Wound Journal, is now available online and will appear in an upcoming issue of the journal.
About the Trial (Protocol 310)
Patients between 18 and 85 years of age with confirmed type 1 or type 2 diabetes and with chronic complex diabetic foot wounds that extended through the dermis and into the subcutaneous tissue with evidence of exposed muscle, tendon, bone, and/or joint capsule were considered for this study. Ulcers had to be able to accommodate up to three 5 cm x 5 cm pieces of Grafix. Patients were excluded from the trial if the ulcer had any evidence of active infection at screening. Patients received treatment with Grafix weekly for up to 16 weeks. The primary endpoint measured 100% granulation of wound by 16 weeks as determined by the investigator. Secondary endpoints included complete wound closure rates, time to 100% granulation, number of applications, and percent wound area reduction at 4 weeks, 8 weeks, 12 weeks, and 16 weeks. 31 patients were enrolled, and 27 completed the study. The patient group had significant co-morbidity, with over 80% having hypertension, over 60% being current or former smokers, 55% having heart disease and 45% having had a previous partial amputation. The mean wound area was 14.6 cm2 with mean duration of 7.5 months, and 67.7% of patients failed advanced wound therapies prior to Grafix. For patients completing the protocol, the primary endpoint, 100% wound granulation by week 16, was met by 96.3% of patients in a mean of 6.8 weeks. Complete wound closure occurred in 59.3% (mean 9.1 weeks). Osiris Therapeutics partnered with CPC Clinical Research, an Academic Clinical Research Organization (CRO), who was responsible for data management and pharmacovigilance services. The protocol was submitted to clinicaltrials.gov (Reference # NCT02260609).
About Grafix®
Grafix is a cryopreserved placental membrane comprised of an extracellular matrix (ECM) rich in collagen, growth factors and viable cells native to the tissue. Grafix is processed using Osiris’ proprietary BioSmart™ technology; it is flexible and conforming and designed for application directly to hard-to-treat acute and chronic wounds, including but not limited to diabetic foot ulcers, venous leg ulcers and thermal burns.
About Osiris Therapeutics
Osiris Therapeutics, Inc., based in Columbia, Maryland, is a world leader in researching, developing and marketing regenerative medicine products that improve health and lives of patients and lower overall healthcare costs. Having developed the world’s first approved stem cell drug, the company continues to advance its research and development in biotechnology by focusing on innovation in regenerative medicine – including bioengineering, stem cell research and viable tissue based products. Osiris has achieved commercial success with products in orthopaedics, sports medicine and wound care, including BIO4®, Cartiform®, Grafix®, TruSkin™ and Stravix™.
Osiris, Grafix, and Cartiform are registered trademarks of Osiris Therapeutics, Inc.; TruSkin and Stravix are trademarks of Osiris Therapeutics, Inc. BIO4 ® is a trademark of Howmedica Osteonics Corp. 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. 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 biologic drug candidates and marketed Biosurgery products (including Grafix, Stravix, TruSkin, BIO4 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.
For additional information, please contact: Diane Savoie Osiris Therapeutics, Inc. (443) 545-1834 OsirisPR@Osiris.com
Source: Osiris Therapeutics, Inc.
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