Seventy-five percent (75%) of patients in both groups had one or more risk factors for poor healing. There were no significant differences in the frequency of serious adverse events between the Augment and autograft treated patients. Finally, analysis of human anti-PDGF antibodies indicated only 13% of Augment patients experienced antibody formation at any time point, which dropped to 3.9% at six months. Additionally, 3.5% of autograft patients also had anti-PDGF antibodies. Most importantly, none of the antibodies in either group was neutralizing.

The data above reflect the results of the 397 patient modified intent-to-treat (mITT) study population. Thirty-seven (37) patients were excluded from this analysis, 21 of which were randomized but never treated and 16 which had major protocol deviations which were prospectively identified (e.g. midfoot fusions even though these were a specific exclusion criteria). Thus, the mITT population represents over 90% of all randomized patients and over 95% of all treated patients.

On a strict intent-to-treat (ITT) population in which those patients who were randomized but never treated are counted as automatic failures, 24 week fusion rates on CT scans were 57.9% for patients randomized to Augment and 60.4% for patients randomized to autograft>

Source BioMimetic Therapeutics