Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, informed that the first patient has been dosed in its open-label phase II a trial of Xiaflex (collagenase clostridium histolyticum) for the treatment of idiopathic adhesive capsulitis of the shoulder, also known as frozen shoulder syndrome.
Xiaflex (collagenase clostridium histolyticum) is a biologic approved in the US and the EU for the treatment of adult Dupuytren's contracture patients with a palpable cord. It is a non-surgical treatment for this condition and consists of a highly purified combination of several subtypes of collagenase, derived from clostridium histolyticum, in specific proportion. Together, the collagenase sub-types work synergistically to break the bonds of the triple helix collagen structure more effectively than human collagenase. Xiaflex is currently in phase III of a global development program for the treatment of Peyronie's disease, in phase II a of development for the treatment of frozen shoulder syndrome (adhesive capsulitis) and in phase I b of development for the treatment of cellulite (edematous fibrosclerotic panniculopathy).
Frozen Shoulder syndrome is a common, prolonged, painful condition of the shoulder in which increased capsular collagen thickening and subsequent capsular contraction in the shoulder joint is thought to cause a loss of range of motion in the shoulder. The condition is believed to affect approximately two percent of the general adult population and the full duration of the frozen stage of disease can last up to 3.5 years.
“The shoulder joint is crucial for many essential activities and when its function becomes limited, it can have a significant impact on patients' daily living,” said Dr James Tursi, chief medical officer of Auxilium. “We are pleased that the trial is underway and anticipate that the results may demonstrate the potential of Xiaflex as an innovative acute option for orthopaedic surgeons to treat frozen shoulder syndrome over approximately six weeks with a minimally invasive treatment option.”
“Initiation of the frozen shoulder syndrome trial represents another important development milestone for Auxilium and we are excited to advance the third potential indication for Xiaflex,” said Armando Anido, chief executive officer and president of Auxilium Pharmaceuticals. “We believe that Xiaflex represents a pipeline in a product and expect to develop multiple future indications, in addition to its proven benefit in treating adult Dupuytren's contracture in patients with a palpable cord.”
The phase II a study is an open-label, controlled dose-ranging study designed to assess the safety and efficacy of Xiaflex for the treatment of frozen shoulder syndrome in comparison to an exercise-only control group. The study will involve approximately 50 adult men and women at approximately nine sites throughout the US. Topline study results are expected in the first half of 2013.
To qualify for the frozen shoulder syndrome study, patients must have unilateral idiopathic adhesive capsulitis of the shoulder with restricted range of motion in the affected shoulder for at least three months, but not more than 12 months. Following screening and determination of study eligibility, subjects will be assigned to four groups that vary in dosing (injection volume and concentration) or a fifth group receiving shoulder exercises only. Patients may receive up to three ultrasound-guided injections of varying doses of Xiaflex (ranging from 0.29 mg to 0.58 mg in varying concentrations) separated by a minimum of 21 days and all patients will be instructed to perform home shoulder exercises. The study's primary endpoint is the change (degrees) from baseline to the day 92 follow-up in forward flexion (active) in the affected shoulder. Safety assessments, including immunogenicity testing, will be made during all study visits.
Frozen Shoulder syndrome, also known as idiopathic adhesive capsulitis, is a common, prolonged, and painful disorder of diminished shoulder motion. The full duration of the frozen stage of disease can last from 1 to 3.5 years with a mean of 30 months. Increased capsular collagen thickening and subsequent capsular contraction in the glenohumeral joint is thought to cause restriction in both active and passive range of motion in the shoulder.
Auxilium Pharmaceuticals, Inc. is focussed on developing and marketing products to predominantly specialist audiences, such as urologists, endocrinologists, certain targeted primary care physicians, hand surgeons, subsets of orthopaedic, general, and plastic surgeons who focus on the hand, and rheumatologists.