Replies to post #6 on BioSpecifics Technologies Corp. (BSTC)

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8:32AM BioSpecifics Tech announces top-line data from Phase 2 trial of CCH for canine lipoma; trial did not meet its primary endpoint of a statistically significant post-treatment difference in the mean percent change in lipoma volume by CT scan; however, in the responder analysis there was a statistically significant reduction in lipoma surface area among dogs treated with CCH (p=0.0084) (BSTC) 21.79 :

Co announced top-line data from Chien-804, the placebo-controlled, double-blind, randomized Phase 2 trial evaluating the efficacy of collagenase clostridium histolyticum (CCH) in canines with benign subcutaneous lipomas. Lipomas are encapsulated deposits of fat often detected as bulges under the skin and affect an estimated 1.7 million dogs in the U.S. The trial did not meet its primary endpoint of a statistically significant post-treatment difference in the mean percent change in lipoma volume by CT scan; however, in the responder analysis there was a statistically significant reduction in lipoma surface area among dogs treated with CCH (p=0.0084).
Chien-804 enrolled 37 dogs in a single injection study randomized 1:1 CCH to placebo with lipoma volume being measured by CT scan and lipoma surface area being measured by caliper at baseline, one month and 90 days. The data at 90 days show a post-treatment difference in the mean percent change in lipoma volume by CT scan between the CCH and placebo-treated groups of -11.58% (p=0.52), which was not statistically significant. The percent change at 90 days in mean visible surface area measured by caliper showed a difference of -24.18% (p=0.09), which approached statistical significance. Among those dogs whose lipomas decreased by 50%, the results achieved statistical significance and showed that the visible surface area as measured by caliper decreased by 50% or more in 47.4% of CCH-treated dogs (9 out of 19) versus 5.9% of placebo-treated dogs (1 out of 17), with a p-value of 0.0084. A questionnaire administered to pet owners, while blinded to the study, showed 84.2% satisfaction with the results of CCH treatment versus 33.4% satisfaction with the placebo results (p=0.005).