Osiris Therapeutics, Inc. (NASDAQ: OSIR), reported today that its multi-center, randomized, controlled clinical trial comparing the safety and effectiveness of Grafix® to standard of care in patients with chronic diabetic foot ulcers had met the pre-specified stopping rules for overwhelming efficacy as determined by the data monitoring committee during a planned interim analysis. For the primary endpoint, 62% of patients receiving Grafix had complete wound closure compared to only 21% (p<0.0001) of patients who received conventional treatment for their wounds - a relative improvement of 191% and the largest ever reported from such a study. A total of 131 patients were enrolled with the interim analysis being conducted on the first 97 to complete the trial.
The trial also reached statistical significance in favor of Grafix on all top-line secondary endpoints, demonstrating faster wound closure and a reduction in the number of treatments needed to achieve wound closure. In the crossover phase of the trial, patients whose wounds failed to close after 12 weeks of standard of care had an 80% closure rate when switched to Grafix. Importantly, patients randomized to receive standard of care were 74% more likely to experience an adverse event than those receiving Grafix (p=0.008). As a result, the blinded phase of the trial is being discontinued immediately and all patients randomized to the control arm will be offered treatment with Grafix.
“Today, Osiris has established a new standard in diabetic wound care and has demonstrated to the world the tremendous impact stem cell products can have in medicine,” said C. Randal Mills, Ph.D., Chief Executive Officer. “Diabetic foot ulcers afflict 25% of all diabetics and are responsible for more hospitalizations than any other diabetic complication. With 25 million diabetics in the United States, the cost to our health care system is enormous. Through this rigorous study we have shown that Grafix can heal more patients, in less time, and with fewer complications.”
Top-Line Data from the Interim Analysis of Protocol 302
|Complete Wound Closure at 12 Weeks||62.0%||21.3%||p<0.0001|
|Complete Wound Closure for Patients Receiving All Treatments*||71.4%||27.0%||p=0.0001|
|Time to Complete Closure||42 days||70 days||p=0.017|
|Number of Treatments to Closure||6||12||p=0.0001|
|Closure with Grafix in Patients Failing Standard of Care (Crossover)**||80.0%||N/A||N/A|
|Patients with at least One Adverse Event||38.0%||66.0%||p=0.008|
|*Patients attending all scheduled treatment visits (n=79). **n=20 at the time of the interim analysis.|
“These data are very compelling as we have not had a new cellular therapy for diabetic foot ulcers in over 10 years,” said Dr. Larry Lavery, Principal Investigator and Professor of Plastic Surgery, University of Texas Southwestern Medical Center. “Compared to other similarly designed studies, this trial demonstrates, by far, the largest relative improvement in complete wound closure. This is great news for our patients with diabetic foot ulcers that are at such high risk of losing their legs.”