Xiaflex collagenase clostridium histolyticum: Phase II data
Top-line data from an open-label, dose-escalation, U.S. Phase II trial in 14 lipoma patients showed that a single injection of Xiaflex met the primary endpoint of actively reducing the visible surface area of the lipoma as measured by caliper from baseline to 6 months post-injection (p<0.0001 for all doses combined). Patients received a single injection of 0.058, 0.15, 0.29 or 0.44 mg Xiaflex. BioSpecifics said patients in the highest dose group (75% of commercial dose) achieved the best result with a mean reduction in lipoma visible surface area of 67% from baseline to 6 months post-injection. Additionally, 75% of patients in the 0.44 mg Xiaflex arm achieved a reduction of >=50% in lipoma visible surface area. No treatment-serious adverse events were reported. This half, BioSpecifics plans to start a placebo-controlled Phase II trial with Xiaflex to treat lipoma. ...