BioSpecifics commences XIAFLEX Phase II trial in human lipoma

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 Europe and Eurasia, today 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.

"The initiation of this Phase II trial is important for patients suffering with lipoma as there is currently no FDA-approved pharmaceutical for this condition," commented Thomas Wegman, President of BioSpecifics. "We are enthusiastic about the promising clinical results already seen with injectable collagenase in this indication, as well as in canine lipoma for which we also have an ongoing Phase II trial. We look forward to completing both of these studies next year."

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.   
• The study will also collect information of lipoma characteristics and will administer a questionnaire to each subject prior to injection and at each follow-up visit to gather information regarding the assessment of treatment in relation to how much the lipoma bothers the subject.
• Safety information will also be collected.

"There is great need for a non-surgical treatment for lipomas of all sizes and we are excited about the therapeutic potential of injectable collagenase for this condition," said Zachary Gerut, M.D., lead investigator on the trial. "Larger lipomas can cause pain or discomfort for patients and they can grow to interfere with normal daily activities. In addition, many patients suffer with multiple lipomas scattered over their bodies, which can be quite unsightly."

BioSpecifics' strategic partner Auxilium Pharmaceuticals, Inc. (Auxilium) has the option to license development and marketing rights to this indication, which would trigger an opt-in payment and potential future milestone and royalty payments from Auxilium to BioSpecifics.