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BioSpecifics Technologies Corp. Announces Positive Top-Line Results from Phase 2 Trial of CCH for Treatment of Human Lipoma

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The primary endpoint of this randomized, double-blind placebo-controlled Phase II trial, 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 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. The trial also gathered qualitative lipoma characteristics and an assessment of patient satisfaction through a questionnaire administered to each subject prior to injection and at each follow-up visit.Top-line results from this trial, which involved a single injection of 0.58 mg of CCH, include:
  • 81.3 percent reduction in the visible surface area for patients who received CCH compared to a 2.1 percent increase for treatment with placebo in the target lipoma, as measured by caliper at six months post-treatment, resulting in an 83.4 percent difference in favor of CCH (p˂0.0001).
  • 89.5 percent of CCH patients (17 of 19 patients) were responders at six months post-injection (showed a ≥50% decrease in lipoma visible surface area relative to baseline) compared to 0 percent for placebo (p˂0.0001).
  • The mean decrease in the length of the target lipoma at 6 months was 64.8 percent from baseline for CCH treated lipomas and 0.2 percent increase for placebo (p<0.0001).
  • As measured by caliper, the mean decrease in lipoma visible surface area at three months was 62.5 percent for CCH and 0.4 percent increase for placebo (p<0.0001).
  • As measured by caliper, the mean decrease in lipoma visible surface area at one month was 26.8 percent for CCH and 0.2 percent increase for placebo (p=0.0042).
  • The mean decrease in lipoma volume as measured by MRI at 6 months was 47.2 percent for CCH treated lipomas and 4.9 percent for placebo (p=0.0013).
  • Patient satisfaction was assessed through a questionnaire administered to each subject prior to injection and at the one, three and six month follow-up visits. For the lipomas that received CCH treatment, at six months, 57.9 percent of patients reported being very satisfied; 36.8 were somewhat satisfied and zero were not satisfied verses placebo where 21.1 percent were very satisfied; 15.8 percent were somewhat satisfied and 57.9 percent were not satisfied (p=0.0010 in favor of CCH).
  • There were no drug-related serious adverse events reported during the trial and CCH was well-tolerated, with no trial dropouts. The most frequent treatment-related adverse events were localized to the injection site and included bruising, injection site swelling/pain and pruritus. These adverse events are consistent with those seen previously in clinical experience.
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Occurred on:
Jun 13, 2016
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Related Keywords Human Lipoma, Collagenase Clostridium Histolyticum, Cch