Auxilium Announces Results Of Xiaflex In Dupuytren's MULTICORD Contracture Trial

(RTTNews) - Auxilium Pharmaceuticals Inc. (AUXL) announced the results of the MULTICORD or Multiple Treatment Investigation of Collagenase Optimizing the Resolution of Dupuytren's study, an open-label, Phase 3b study (AUX-CC-867) of the treatment of multiple joints injected concurrently.

The company said that study demonstrated that two concurrent injections of XIAFLEX (collagenase clostridium histolyticum or CCH) in patients with multiple Dupuytren's contractures resulted in comparable improvement in joint contracture and range of motion to those seen in previous studies when XIAFLEX was administered as single injections, 30 days apart. Adverse event or AE rates were also comparable to single injection administration 30 days apart.

The firm noted that it believes the results of this global, multicenter Phase 3b trial, together with data from the Company's earlier MULTICORD studies (AUX-CC-861 and AUX-CC-864), support the Company's planned supplemental Biologics License Application (sBLA) submission to the U.S. Food and Drug Administration or FDA in the first quarter of 2014 seeking expansion of the labeling for the concurrent treatment of multiple palpable cords.

The MULTICORD study found that concurrent injections of XIAFLEX reduced total fixed flexion contracture or FFC by an average of 74.4 percent and improved the total range of motion by a combined average 66.6 degrees. Hand functionality as measured by the URAM (Unite Rhumatologique des Affections de la Main) scale, a 9-item validated scale developed to assess functional outcome of patients suffering from Dupuytren's disease, improved an average of 12.3 points. The estimated clinically important change of the URAM scale is 2.9 points.

According to the company, the most common treatment-related AEs reported in this study were mild or moderate and consistent with those seen in the Phase 3 clinical studies utilizing single injections. The most common were swelling, contusion and pain in extremity. Six treatment related or possibly treatment related serious adverse events or SAEs were observed among the 715 subjects enrolled, including one tendon rupture, one case of serious allergic reaction / possible anaphylaxis, one case of post procedural hemorrhage, one case of lymphangitis, one case of deep vein thrombosis/pulmonary embolism and one case of post injection malaise, swelling and pain.

Dupuytren's disease is a progressive condition affecting the hand, specifically the layer of tissue just under the skin of the palm and fingers. While this layer of tissue normally contains collagen, in patients with Dupuytren's there is an increase in the amount of collagen produced. Abnormal collagen build-up results in nodule and cord formation that worsens over time. Eventually, rope-like collagen cords may form, thicken and shorten, causing the fingers to be drawn in toward the palm. This thickening and shortening of the Dupuytren's cord can reduce the finger's range of motion (how much a person can move or straighten them).