XIAFLEX Phase II Trial In Human Lipoma

Filed under: Lipoma Treatment - 15 Jan 2013  | Spread the word !

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Until now, there is no approved, non-surgical treatment for lipoma. Nonetheless, it seems that a biopharmaceutical company plans to design a specific treatment to help people with lipoma. It’s named BioSpecifics Technologies Corp. (NASDAQ: BSTC) and developed collagenase-based products.


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These products are marketed as XIAFLEX in the U.S. and XIAPEX® in Europe and Eurasia. The company announced that it has started its Phase II trial of XIAFLEX (collagenase clostridium histolyticum), a treatment for human lipoma.

Phase II trial is perfect for patients who suffer from lipomas as there is no FDA-approved pharmaceutical for this type of condition. Thomas Wegman, President of Biospecifics said: “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.”


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The study involves a single injection, open label trial and will enroll 14 patients. The treatment is administered in four ascending doses, ranging from 0.058 mg to 0.44 mg of XIAFLEX.

Efficacy endpoints will include:

  • the primary efficacy endpoint will consist of a change in the visible area of the lipoma at about 6 months post injection
  • the secondary efficacy endpoints refer to a change in length of the lipoma

The study will also include pieces of information of lipoma features and will administer a questionnaire to each patient prior to injection. Additionally, safety information will also be a part of this research.


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This study could lead to a wonderful solution to a non-surgical treatment for lipomas of all sizes. The injectable collagenase for lipomas has a great potential, an idea supported also by Zachary Gerut, M.D., lead investigator on the trial.

Auxilium Pharmaceuticals, Inc. (Auxilium), the strategic partner of Biospecifics can opt for license development and marketing rights to this indication. This would mean an opt-in payment and also potential future milestone and royalty payments from Auxilium to Biospecifics.

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