BioSpecifics Technologies Corp. (BSTC) announced that it has initiated its Phase II trial of Xiaflex (collagenase clostridium histolyticum) for the treatment of human lipoma. Human lipomas are encapsulated deposits of benign fat often detected as bulges under the skin and are diagnosed in 575,000 U.S. patients annually.
BioSpecifics anticipates that it will complete the 14 patient, single center dose escalation study by the end of the third quarter of 2013.
This study is a single injection, open label trial and is planned to enroll 14 patients. Xiaflex is being administered in four ascending doses, ranging from 0.058 mg to 0.44 mg of Xiaflex.
The primary efficacy endpoint will be a change in the visible surface area of the target lipoma, as determined at 6 months post injection.
The secondary efficacy endpoints include the (1) change in length of the target lipoma; (2) relative change in lipoma surface area at one month and three months and (3) relative change in lipoma volume as measured by MRI.
Lipomas are encapsulated fat deposits that occur under the skin and they are common in humans.
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