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Osiris Therapeutics Says Trial on Grafix Met All Primary, Secondary Endpoints

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Osiris Therapeutics, Inc. (NASDAQ: OSIR), the leading stem cell company focused on developing and marketing products in orthopedics, sports medicine and wound care, announced today that Dr. Matthew Regulski, Medical Director of the Wound Institute of New Jersey, will present clinical trial data, including secondary endpoints, from Osiris' multi-center, randomized, controlled clinical trial evaluating the safety and effectiveness of Grafix® in patients with chronic diabetic foot ulcers tomorrow, November 20^th, at the 10^th Annual Desert Foot High Risk Diabetic Foot Conference in Phoenix, Arizona. The trial met all primary, secondary and safety endpoints and demonstrated a statistically significant reduction in infections and hospitalizations for patients treated with Grafix compared to conventional therapy.

“The randomized study not only demonstrated the largest relative effect size for wound closure of any multi-center, controlled trial but, more importantly, showed that Grafix patients had better long-term outcomes and fewer complications,” said Dr. Regulski. “The risk of infection increases the longer a wound is open, and infections are the most common cause of morbidity and mortality in patients with diabetic foot ulcers. This study showed that treatment with Grafix resulted in faster, more complete wound closure, thereby reducing infections, hospitalizations and overall cost.”

For the primary endpoint, 62% of patients receiving Grafix had complete wound closure compared to only 21% of control patients who received conventional treatment (p<0.0001). Newly available long-term data further demonstrated the durable effect of wound closure by Grafix, showing that 82% of wounds that closed within 12 weeks remained closed during the 3 month follow-up phase of the study. Furthermore, significantly more Grafix patients had a 50% reduction in wound size by day 28 versus conventional treatment (62% vs. 36%, p=0.01).

Safety data demonstrated that significantly fewer patients experienced at least one adverse event in the Grafix arm than those receiving conventional treatment (42% vs. 66%, p=0.02), with the most common adverse event being infection. Grafix reduced the incidence of index wound infections by more than half (14% vs. 32%, p=0.05). Also, significantly fewer patients receiving Grafix were hospitalized for wound-related events than those receiving standard treatment (2% vs. 15%, p=0.03).

During the Desert Foot Conference, nine other clinical and scientific posters will be presented by investigators including the presentation of a 34-patient study evaluating wound closure in venous leg ulcers treated with Grafix. In that study, 71% obtained complete wound closure defined as re-epithelialization of the entire wound with 100% of the wounds remaining closed with mean follow-up time of 20.2 months.

“We are committed to developing products that offer patients and physicians solutions for some of the most challenging diseases in medicine,” said Frank Czworka, General Manager of Wound Care for Osiris. “The efficacy demonstrated in this study, combined with our multiple size offerings of Grafix, provides clinical and cost-effective solutions for our patients, physicians and payers.”

Posted-In: News FDA


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