Osiris Therapeutics, Inc. Announces Initiation Of A Phase III Trial For A New Investigational Drug, OTI-15-01, For The Treatment Of Chronic Diabetic Foot Wounds

COLUMBIA, Md.--(BUSINESS WIRE)--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.

“This study represents the next step in the development of our placental based technology platform”

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 Ulcers 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 BIO^{4 ™}, 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

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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. JAMA, 293(2).