Osiris Therapeutics (MD, USA) has started a new Phase III trial with placental technology product OTI-15-01 for patients suffering from chronic diabetic foot ulcers
Osiris Therapeutics, Inc. (MD, USA) 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 company is a leader in cellular and regenerative medicine and focuses on developing and marketing products to treat conditions in wound care, orthopedics and sports medicine.
OTI-15-01 is a placental technology product that is being developed as an investigational new drug intended to heal wounds in patients suffering from chronic diabetic foot ulcers that have not responded to standard of care therapy.
This Phase III trial is designed as a randomized, controlled, blinded study, and is expected to enroll up to 224 patients in approximately 20 different 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 end points 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.
“I am delighted that this Phase III clinical trial is underway,” stated 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.”
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 utilized to treat burns and cutaneous ulcers. This protocol for OTI-15-01 is conducted under the Investigational New Drug (IND) application IND 16383.
“This study represents the next step in the development of our placental based technology platform,” explained Lode Debrabandere, 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.”