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BioSpecifics Technologies Corp Announces Positive Top-line Data From XIAFLEX Phase IIa Study For Frozen Shoulder


Tuesday, 26 Mar 2013 08:00am EDT 

BioSpecifics Technologies Corp announced positive, statistically top-line data from the Phase IIa study of XIAFLEX for the potential treatment of frozen shoulder (adhesive capsulitis). positive, statistically top-line data from the Phase IIa study of XIAFLEX for the potential treatment of frozen shoulder (adhesive capsulitis). 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 improvement from baseline in forward flexion vs. the exercise-only group. The 0.58mg (1mL) dosing arm also showed statistically improvement from baseline in shoulder abduction vs. the exercise-only group. 

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