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Osiris Announces Initiation of a Phase III Trial for a New Investigational Drug, OTI-15-01, for the Treatment of Chronic Diabetic Foot Wounds
[October 06, 2015]

Osiris Announces Initiation of a Phase III Trial for a New Investigational Drug, OTI-15-01, for the Treatment of Chronic Diabetic Foot Wounds


Osiris Therapeutics, Inc. (NASDAQ:OSIR), the leading cellular and regenerative medicine company focused on developing and marketing products to treat conditions in wound care, orthopaedics and sports medicine, today announced the initiation of its Multicenter, Randomized, Blinded Study with an Open-Label Extension Option to Evaluate the Safety and Efficacy of OTI-15-01 for the Treatment of Chronic Diabetic Foot Ulcers.

The phase III trial is designed as a randomized, controlled, blinded study, and is expected to enroll up to 224 patients in approximately 20 sites. Patients will be randomized to receive OTI-15-01 plus standard of care versus standard of care alone, which includes debridement, a non-adherent dressing, and standardized off-loading.

The primary endpoint is the proportion of patients with complete wound healing by week 12, with confirmation of durability of complete wound healing during two subsequent visits two weeks apart. Secondary endpoints include time to healing, week 4 wound size reduction, number of applications and overall safety, including wound specific adverse events. Patients in the control arm who receive standard of care and do not heal within 12 weeks will be able to receive active drug in an open-label crossover arm of the trial for up to 12 additional weeks. The study design was reviewed by the FDA and meets the requirements established by FDA in the 2006 guideline for Industry clinical trials for products used to treat burns and cutaneous ulcers. This protocol for OTI-15-01 is conducted under the Investigational New Drug (IND) application IND 16383.

"I am delighted that this Phase III clinical trial is underway," said Dr. Jon Hopper, Chief Medical Officer. "Every day in the United States, many thousands of patients suffer severe consequences because they live with a wound that won't heal. Osiris is committed to help them, by developing next generation regenerative medicine products that work. Our goal is to lead the way in the wound care industry by investing in well designed, high quality clinical studies that strengthen the evidence base in this rapidly developing field."

"This study represents the next step in the development of our placental based technology platform," said Lode Debrabandere, Ph.D., President and Chief Executive Officer. "Osiris is a leader in stem cell technology and has a deep understanding of the development and manufacturing of stem cell containing biologics. This next generation product meets the highest quality standards for a biologic, and contains consistent amounts of viable, potent cells. We believe that delivering these directly to the wound bed is the best approach for patients who are suffering from chronic non-healing diabetic foot ulcers."

About Diabetic Foot Ulcers

A diabetic foot ulcer (DFU) is an open sore that is located on the heel, toes, top, or bottom of the foot; these ulcers often start out as a cut, but can get worse over time. Of the 29.1 million Americans1 currently living with diabetes, a quarter will develop Diabetic Foot Ulcer in their lifetime. These foot ulcers are common to patients with diabetes, because of the neuropathy associated with the disease. This nerve damage leads to decreased sensation and unrecognized foot injuries that commonly develop into chronic wounds.2 Diabetic patients account for over 60% of all non-traumatic limb amputations.1



About OTI-15-01

OTI-15-01 is the next generation placental technology product which is being developed as an investigational new drug intended to heal wounds in patients suffering from chronic DFUs that have not responded to standard of care therapy. OTI-15-01 for this indication is regulated by the FDA under regulations 21 CFR 1271, 210, 211, and 312.


OTI-15-01 is comprised of several components known to be critical for effective wound healing including a collagen rich matrix, growth factors and neonatal fibroblasts, epithelial cells, endothelial cells, and mesenchymal stem cells (MSCs). These cell types mediate their functions in response to the local tissue microenvironment and secrete a variety of growth factors and extracellular matrix proteins that orchestrate wound healing. IND 16383 is investigating the impact of this on clinical outcomes, specifically healing rates, in patients with chronic, non-healing diabetic foot ulcers.

About Osiris Therapeutics

Osiris Therapeutics, Inc., based in Columbia, Maryland, is the 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, Prochymal®, Osiris then went on to develop and commercialize a series of human tissue products for orthopaedics, sports medicine and wound care, including BIO4 ™, Cartiform® and Grafix®. 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, Grafix and Cartiform are registered trademarks of Osiris Therapeutics, Inc. BIO4 is a trademark of Stryker Corporation (NYSE: SYK) and Prochymal is a trademark of Mesoblast Limited (ASX: MSB). 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, 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.

1 Centers for Disease Control and Prevention (CDC). (2014). National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States, 2014. Atlanta, GA: US Department of Health and Human Services, Centers for Disease Control and Prevention; 2014. (Available at http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf)

2 Singh, N., Armstrong, D. G., & Lipsky, B. A. (2005). Preventing foot ulcers in patients with diabetes. JAMA293(2).


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