8:33AM BioSpecifics Tech announces positive top-line data from Phase 2 clinical trial of CCH for the treatment of human lipoma; primary efficacy outcome of active reduction of the visible surface area of the lipoma as measured by caliper was met (BSTC) 21.83 :
Co announced top-line data from the Phase 2 dose escalation clinical trial of collagenase clostridium histolyticum (CCH) for the treatment of human lipoma. Lipomas are benign fatty tumors that usually present as painful or palpable lumps in the subcutaneous tissues. 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). There were no serious adverse events reported during the trial.
"Based on the results from both studies reported to date, we intend to initiate a placebo-controlled study to further assess the efficacy and safety of CCH for the treatment of human lipoma in the first half of 2014. We also plan to explore the potential to expand CCH into new pipeline indications with unmet medical needs this year."
BioSpecifics' strategic partner Auxilium Pharmaceuticals (AUXL) has the option to exclusively license development and marketing rights to the human lipoma indication following completion of a new trial, which would trigger an opt-in payment and potential future milestone and royalty payments from Auxilium.
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