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BioSpecifics (BSTC) Reports Statistically Significant XIAFLEX Phase IIa Data

March 26, 2013 8:05 AM EDT Send to a Friend
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BioSpecifics Technologies Corp. (Nasdaq: BSTC) announced positive, statistically significant top-line data from the Phase IIa study of XIAFLEX for the potential treatment of frozen shoulder (adhesive capsulitis).

"We are very encouraged by these positive results and look forward to progress in this program which Auxilium (Nasdaq: AUXL) expects in the second half of this year," reflected Thomas L. Wegman, President of BioSpecifics. "We believe there is strong potential for XIAFLEX in frozen shoulder as there are few optimal treatment strategies and no approved therapies available. These data further support the vast potential of XIAFLEX for many conditions and diseases caused by collagen accumulation, in addition to the five indications in clinical development and the sBLA under review at the FDA for XIAFLEX for Peyronie's disease."

This open-label, controlled dose-ranging Phase IIa study was conducted by BioSpecifics' strategic partner Auxilium Pharmaceuticals, Inc. (Auxilium) and was designed to assess the safety and efficacy of XIAFLEX for the treatment of Stage 2 unilateral idiopathic frozen shoulder in comparison to an exercise-only control group.

As reported by Auxilium, this study involved 50 adult men and women at 11 U.S. sites. Four cohorts of 10 patients each received up to three ultrasound-guided extraarticular injections of varying doses of XIAFLEX (ranging from 0.29mg to 0.58mg in three different volumes; 0.5, 1.0, or 2.0 mL), separated by a minimum of 21 days. All patients were instructed to perform home shoulder exercises. The fifth cohort of ten patients received no XIAFLEX injections and only performed home shoulder exercises. The study's primary endpoint was the change (in degrees) from baseline to the day 92 follow-up in active forward flexion in the affected shoulder compared to the exercise-only cohort. Safety assessments were made during all study visits and immunogenicity testing was performed at screening and day 92.

Both the 0.58mg (1mL) and 0.58mg (2mL) dosing arms showed positive, statistically significant improvement from baseline in forward flexion vs. the exercise-only group. The 0.58mg (1mL) dosing arm also showed statistically significant improvement from baseline in shoulder abduction vs. the exercise-only group. Positive trends with improvement in degrees were also seen in other active range of motion (AROM) assessments vs. the exercise-only group. Twenty-nine study patients (72.5%) received three XIAFLEX injections with 5 subjects receiving two injections and 6 subjects receiving one injection only.

Patients were also assessed using the American Shoulder and Elbow Surgeons (ASES) Scale for function and pain. Both the 0.58mg (1mL) and 0.58mg (2mL) cohort demonstrated statistically significant improvement in pain and function over baseline scores vs. the exercise-only group (p<0.05).

There were no drug-related serious adverse events reported and all treatment-related adverse events were consistent with XIAFLEX use in other approved and potential indications. For more details on the data reported for this study, please refer to Auxilium's press release issued yesterday, March 25, 2013.

Frozen shoulder (adhesive capsulitis) is an inflammation and thickening of the shoulder capsule causing a loss of range of motion in the shoulder. It is known to be caused by trauma but there are other unknown causes. It is estimated to affect between 20 and 50 million individuals worldwide with a slightly higher incidence in women. It typically occurs in patients between 40-70 years of age. Auxilium estimates that approximately 300,000 cases of frozen shoulder are diagnosed annually and approximately 10% are treated with an invasive intervention (surgery or manipulation under anesthesia) on an annual basis.

These results follow positive results previously reported by BioSpecifics for its 60 patient Phase II randomized, placebo-controlled, double-blind dose-response study in which BioSpecifics reported statistically significant differences in the highest injectable collagenase dose group compared to placebo regarding active elevation, passive external rotation and function score.




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