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BioSpecifics Technologies Corp. Announces Top-line Data from Phase 2 Trial of CCH for Canine Lipoma
Date:12/23/2013

LYNBROOK, N.Y., Dec. 23, 2013 /PRNewswire/ -- BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® in the U.S. and XIAPEX® in the EU, today 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).

"We are disappointed that the study did not meet its primary endpoint but are pleased that we achieved statistical significance in a responder analysis of those dogs who had a 50% decrease in lipoma surface area as measured by caliper, which is a standard method for measuring a subcutaneous lipoma," commented Thomas L. Wegman, President of BioSpecifics. "We are also encouraged to see a high satisfaction rating from the owners of pets who received CCH and hope to be able to offer them this minimally-invasive treatment."

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), whic
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