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BioSpecifics Announces Positive XIAPEX® Data Presented at XVI Annual Federation of European Societies for Surgery of the Hand Congress
Date:6/1/2011

ad not been previously operated experienced a decrease in fixed flexion contracture of 80 +/- 2.0%.(1) These results suggest that because repeat surgery is associated with a higher rate of complications as compared to initial surgery, XIAPEX may offer a promising alternative to patients who have had recurrence of Dupuytren's contracture following surgery.

There were two additional presentations discussing data on XIAPEX at the May 2011 FESSH Congress, as follows.

  • In a 9-month, open-label study in which 137 Dupuytren's contracture patients with primary flexion deformities of 20-100 degrees for MP joints or 20-80 degrees for proximal interphalangeal [PIP] joints received less than or equal to 3 CCH (0.58 mg) injections/cord (less than or equal to 5 injections/patient) at 30-day intervals, data were reported from patients enrolled at 12 sites in Denmark, Finland, Sweden, Switzerland and the United Kingdom. The primary endpoint was clinical success, defined as a reduction in contracture to less than or equal to 5 degrees 30 days after the last injection. The safety profile in this subgroup of patients was similar to that observed in previous studies. Long-term follow-up data are not yet available.(2)

  • In tissue explant cultures treated with XIAPEX, enzymatic digestion was most rapid in the first four hours following injection, with nearly complete lysis of collagen occurring within 12 hours. Collagen lysis in these in vitro experiments was confined to the area and volume of the injection, with sharp demarcation between the affected and adjacent unaffected areas. The result in these in vitro experiments appears to be selective lysis of the structural collagen components of the Dupuytren's cord with sparing of arteries, nerves and capillaries following local injection.(3)

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