Skin Lipomas

January 27, 2014

BioSpecifics Technologies has released results of a phase II trial of collagenase clostridium histolyticum (CCH) for the treatment of human lipoma. The phase II, open-label, single-center dose escalation study assessed the safety and efficacy of CCH in 14 patients with lipoma, divided into four dose cohorts. Each patient received a single injection of CCH in one of four ascending doses based on the current commercial dose of CCH in marketed indications, ranging from 0.058mg (10% of commercial dose) to 0.44mg (75% of commercial dose). The primary efficacy outcome of active reduction of the visible surface area of the lipoma as measured by caliper was met, combining all patients (p<0.0001). Data showed patients in the highest dose group (75% of commercial dose) achieved the best efficacy results with an average of 67% reduction of lipoma visible surface area as measured by caliper at six months post-treatment. Additionally, data demonstrated 75% of patients in the highest dose group achieved reduction of 50% or more in lipoma visible surface area. There were no serious adverse events reported during the trial. A follow-up, placebo-controlled study will be initiated in the first half of 2014.

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