The Journal of Hand Surgery Publishes Initial Phase III Data on XIAFLEX(TM) (formerly known as AA4500), Auxilium's Investigational Treatment for Patients with Dupuytren's Contracture
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- Published on Thursday, 26 July 2007 04:00
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MALVERN, PA, USA | July 24, 2007 | Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL) today announced that final results of the initial Phase III trial with XIAFLEXTM (clostridial collagenase for injection) in patients with Dupuytren's contracture have been published in the most recent issue of The Journal of Hand Surgery (July-August 2007, vol. 32, no. 6). The results show that ninety-one percent of patients (21 of 23) treated with up to 3 injections of XIAFLEX achieved clinical success (reduction in joint contracture to within 0o to 5o of normal) in the double-blind phase. 86% of metacarpophalangeal joints, MCP joints (12 of 14), and 100% of proximal interphalangeal joints, PIP joints (9 of 9), were successfully treated. No patient on placebo achieved clinical success. These data were previously released by the Company and reported in abstracts.
Of the 19 patients entering the open label phase, 15 had previously received placebo, and 4 had received active drug but required further treatment due to incomplete success or treatment failure or needed treatment for other contractures. 89.5% of patients (17 of 19) receiving up to 3 injections of XIAFLEX achieved clinical success in at least one treated joint in this phase. 88% of MP joints (14 of 16) and 68% of PIP joints (13 of 19) were successfully treated. "These results are very encouraging for patients with Dupuytren's contracture," said Lawrence Hurst, M.D., Professor and Chair, Department of Hand Surgery, Department of Orthopaedics of the Health Science Center, State University of New York at Stony Brook, co-author of the study. "There is a tremendous need for effective, non-surgical treatment options, to help resolve hand deformities that interfere with activities of daily living and quality of life. Unlike surgery, side effects with XIAFLEX were localized to the injection site and were transient and mild to moderate in nature."
Study Design and Key Findings
This study, conducted by Dr. Lawrence Hurst and Dr. Marie Badalamente of the State University of New York at Stony Brook, reported on the long-term efficacy and tolerability of XIAFLEX in patients with joint contracture of 20o or greater. The study was comprised of a randomized, placebo-controlled, double-blind phase, as well as an open label phase in which all patients received XIAFLEX. In the double blind phase, 23 patients received XIAFLEX, and 12 received placebo. Thirty-three of 35 patients entering the double- blind phase completed the study; 19 of them entered the open-label extension.
Over the double-blind and extension phases, the mean number of injections to achieve success was 1.5 and 1.4, respectively. Clinical success was achieved in a median of 8 days during the double-blind phase. The time to clinical success ranged between 1 and 29 days in the open label extension phase.
The most common adverse events were pain and swelling of the hand at the injection site, and post-injection temporary swelling of a modest nature in the lymph node area of the armpit. There were no nerve or arterial injuries. Adverse events were generally mild to moderate in nature and resolved without treatment within 30 days.
At the 24 month follow-up, contracture recurrence, defined as a return of contracture of at least 20o, was relatively low. Of the 54 successfully treated joints, all were followed up for 12 months following the last injection and half were followed up for 24 months. Over the 24 month period, 5 joints (4 PIP and 1 MCP) had a recurrence. One recurrence occurred before 12 months, 2 at 12 months and 2 at 24 months.
"Recurrence rates with XIAFLEX appear to be favorable to surgery," says Dr. Badalamente, Professor, Department of Orthopaedics, State University of New York at Stony Brook, investigator and co-author of the publication. "Reported contracture recurrence rates after surgery vary widely, from 27% to 80%."
About Dupuytren's Contracture
Dupuytren's contracture is a condition that involves contracture of joints in the hand that impairs patients' ability to straighten and move their fingers due to the production of dense collagen which forms a structure called a "cord". As the disease progresses, functionality of the hand is severely impaired. The incidence of Dupuytren's contracture is highest in Caucasians, historically those of Northern European descent. Most cases of Dupuytren's contracture occur in patients older than 50 years. (1)
The most frequently affected joints associated with Dupuytren's contracture are the joints called the metacarpophalangeal joint, or MCP joint, which is the joint closest to the palm of the hand and the proximal interphalangeal joint, or the PIP joint, which is the middle joint in the finger. The little finger and ring finger are most frequently involved.
(1) Badalamente, M. A., Hurst, L. C. et al., Collagen as a Clinical Target: Nonoperative Treatment of Dupuytren's Disease, The Journal of Hand Surgery, (2002;27A:788-798)
Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing to urologists, endocrinologists, orthopedists and select primary care physicians. Auxilium markets Testim(R) 1%, a topical testosterone gel, for the treatment of hypogonadism through its approximately 190-person sales and marketing team. Auxilium has four projects in clinical development. Auxilium believes that XIAFLEX(TM) (clostridial collagenase for injection), formerly known as AA4500, is in phase III of development for the treatment of Dupuytren's contracture and is in phase II of development for the treatment of Peyronie's disease and Frozen Shoulder syndrome (Adhesive Capsulitis). Auxilium's transmucosal film product candidate for the treatment of overactive bladder (AA4010) is in phase I of development. The Company is currently seeking a partner to further develop this product candidate. Auxilium has two pain products using its transmucosal film delivery system in pre-clinical development. Auxilium has rights to six additional pain products and products for hormone replacement and urologic disease using its transmucosal film delivery system, and options to all indications using XIAFLEX for non-topical formulations. For additional information, visit http://www.auxilium.com.
Safe Harbor Statement
This release contains "forward-looking-statements" within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the interpretation of clinical results published in the July-August issue of The Journal of Hand Surgery, and products in development. All statements other than statements of historical facts contained in this release, including but not limited to, statements regarding future expectations, plans and prospects for the Company, financial guidance and other statements containing the words "believe," "may," "could," "will," "estimate," "continue," "anticipate," "intend," "should," "plan," "expect," and similar expressions, as they relate to the Company, constitute forward-looking statements. Actual results may differ materially from those reflected in these forward-looking statements due to various factors, including general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries and those discussed in the Company's Annual Report on Form 10-K for the period ended December 31, 2006 and in the Company's Quarterly Report on Form 10-Q for the period ended March 31, 2007 under the heading "Risk Factors", which is on file with the Securities and Exchange Commission (the "SEC") and may be accessed electronically by means of the SEC's home page on the Internet at http://www.sec.gov or by means of the Company's home page on the Internet at http://www.auxilium.com under the heading "Investor Relations - SEC Filings." There may be additional risks that the Company does not presently know or that the Company currently believes are immaterial which could also cause actual results to differ from those contained in the forward-looking statements. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements.
In addition, forward-looking statements provide the Company's expectations, plans or forecasts of future events and views as of the date of this release. The Company anticipates that subsequent events and developments will cause the Company's assessments to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward- looking statements should not be relied upon as representing the Company's assessments as of any date subsequent to the date of this release.
SOURCE: Auxilium Pharmaceuticals, Inc.