Grafix success in Diabetic Foot Ulcer trial

Osiris Therapeutics announced it has stopped a study of its Grafix cellular wound care product in Diabetic Foot Ulcer because of "overwhelming efficacy".

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.>

The trial also reached statistical significance in favour 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.