BioSpecifics Technologies Corp. (BSTC) revealed Monday positive, statistically significant top-line results from its placebo-controlled, double-blind Phase II clinical study of collagenase clostridium histolyticum (CCH) for human lipoma treatment. According to the company, the study met its primary endpoint of reduction in the visible surface area of the target lipomas relative to placebo, as determined by caliper, at six months post injection, and also met all secondary efficacy endpoints. There were no serious adverse events reported during the trial.
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BioSpecifics President, Thomas Wegman, said that "We are pleased to report these positive results today as we believe that CCH injection has the potential to provide therapeutic advantages over surgery, the current standard of care, which is the only proven option for lipoma patients."
He continued, "We look forward to the review of these positive results by our partner Endo International plc. Endo has the right to opt-in to this indication, which would transfer responsibility for the future development costs to them and trigger an opt-in payment and potential future milestone and royalty payments to BioSpecifics."
The company indicated the primary endpoint of this randomized, double-blind placebo-controlled stage two study, conducted in 19 patients with two or more benign lipomas of similar size, was the reduction in the visible surface area of the target lipomas relative to placebo, as determined by caliper, at six months post injection.
The company stated the secondary efficacy endpoints included responders at six months post injection who showed a 50% decrease in lipoma visible surface area relative to baseline between CCH and placebo; the change in the length of the target lipoma at six months between CCH and placebo; and the relative change in lipoma visible surface area as measured by caliper at one month and three months.
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