Navigation Links
Auxilium Pharmaceuticals, Inc. Announces Positive Top-Line Results from XIAFLEX® Multi-Cord Study
Date:9/7/2011

MALVERN, Pa., Sept. 7, 2011 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced positive top-line results from a pilot clinical study to assess safety, tolerability, and multiple-dose pharmacokinetics of XIAFLEX® (collagenase clostridium histolyticum) in adult Dupuytren's contracture subjects with multiple  palpable cords.  The tolerability profile following concurrent injection of two doses of XIAFLEX into palpable cords in the same hand is consistent with that demonstrated in pivotal clinical trials following a XIAFLEX injection into a single palpable cord.  

(Logo: http://photos.prnewswire.com/prnh/20101202/MM10881LOGO)

"We were encouraged that multiple injections of XIAFLEX into the same hand concurrently have demonstrated a preliminary tolerability profile clinically similar to that of a single injection," said Dr. James P. Tursi, Chief Medical Officer at Auxilium.   "Concurrent multiple injections of XIAFLEX would offer hand surgeons the ability to treat several joints in the same hand at the same time, which would be similar to historical surgical interventions."  

In this phase IIIb study, 12 adult subjects with 36 palpable cords were enrolled at a single site in Australia.  All subjects were required to have Dupuytren's disease with at least three fixed-flexion contractures, excluding the thumb.  Each subject was given a single injection of XIAFLEX and, if no severe local or systemic reaction was observed, concurrent injections of two doses of XIAFLEX were given into two palpable cords in the same hand.   In the pivotal phase III clinical trials, only a single joint was treated with XIAFLEX and additional joints were required to be treated sequentially every 30 days.  Following the multiple concurrent injections in the pilot study, patients were monitored for safety and pharmacokinetics over 90 days.  The breakdown of cords that were treated concurrently was:

  • Five patients with a single finger containing both an MP and PIP joint,
  • Five patients with two MP joints on two separate fingers,
  • Two patients with a single MP and PIP joint on two separate fingers.

There was no measurable systemic absorption of XIAFLEX, and no severe local adverse events, drug related serious adverse events, or systemic reactions were reported.  A complete analysis of trial data is pending and the Company is seeking publication of full results in an appropriate medical journal.  A larger 60 patient clinical trial is scheduled to begin by mid-September in the U.S. and Australia to assess the efficacy and safety of multiple concurrent injections of XIAFLEX in subjects with multiple Dupuytren's contractures caused by palpable cords.

About Auxilium

Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing products to predominantly specialist audiences, such as urologists, endocrinologists, certain targeted primary care physicians, hand surgeons, subsets of orthopedic, general, and plastic surgeons who focus on the hand, and rheumatologists. Auxilium markets XIAFLEX® (collagenase clostridium histolyticum) for the treatment of adult Dupuytren's contracture patients with a palpable cord and Testim® 1%, a testosterone gel, for the topical treatment of hypogonadism in the U.S. Pfizer has marketing rights for XIAPEX® (the EU tradename for collagenase clostridium histolyticum) in Europe and Asahi Kasei Pharma Corporation has development and commercial rights for XIAFLEX in Japan. Ferring International Center S.A. markets Testim in the EU and Paladin Labs Inc. markets Testim in Canada. Auxilium has three projects in clinical development. XIAFLEX is in phase III of development for the treatment of Peyronie's disease, in phase IIa of development for the treatment of Frozen Shoulder syndrome (Adhesive Capsulitis) and is in phase Ib of development for the treatment of cellulite (edematous fibrosclerotic panniculopathy). Auxilium also has rights to pursue additional indications for XIAFLEX. For additional information, visit http://www.auxilium.com.

SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

This release contains "forward-looking-statements" within the meaning of The Private Securities Litigation Reform Act of 1995, including statements regarding the use of concurrent multiple injections of XIAFLEX to treat several joints in the same hand at the same time; the completion of the analysis of trial data;  publication of full results of the study in an appropriate medical journal; a planned clinical trial to assess multiple concurrent injections of XIAFLEX; products in development for Peyronie's disease, Frozen Shoulder syndrome and cellulite; and the potential for XIAFLEX to be used in multiple indications.  

Forward-looking statements often address Auxilium's expected future financial position or business strategy and plans and objectives of management for future operations. Forward-looking statements provide Auxilium's current expectations or forecasts of future events. Auxilium's performance and financial results could differ materially from those reflected in these forward-looking statements due to various risks and uncertainties.

A more detailed list and description of the risks and uncertainties that Auxilium faces may be found under the heading "Risk Factors" in Auxilium's Annual Report on Form 10-K for the year ended December 31, 2010 and Form 10-Q for the quarter ended June 30, 2011, which are on file with the Securities and Exchange Commission. Given these risks and uncertainties, any or all of the forward-looking statements contained in this release may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Auxilium undertakes no obligation to update publicly any forward-looking statement.    

CONTACT:
James E. Fickenscher
Chief Financial Officer, Auxilium Pharmaceuticals, Inc.
+1-484-321-5900
jfickenscher@auxilium.com
or
William Q. Sargent Jr.
Vice-President, Investor Relations and Corporate Communications
+1-484-321-5900
wsargent@auxilium.com


'/>"/>
SOURCE Auxilium Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Auxilium Pharmaceuticals, Inc. and BioSpecifics Technologies Corp. Announce Plans to Develop Additional Indications using XIAFLEX®
2. Auxilium Pharmaceuticals Announces Investor Event to Occur at 2011 ASSH Meeting on September 9, 2011
3. Auxilium Pharmaceuticals to Present at the Stifel Nicolaus 2011 Healthcare Conference
4. Auxilium Pharmaceuticals, Inc. Announces Promotion of Dr. James P. Tursi to Chief Medical Officer
5. Auxilium Pharmaceuticals to Announce Second Quarter 2011 Results and Conduct Conference Call on Monday, August 1, 2011
6. Auxilium Pharmaceuticals Announces Results from Three Year CORDLESS Extension Study in Dupuytrens Contracture
7. Auxilium Pharmaceuticals to Present at the Bank of America Merrill Lynch 2011 Health Care Conference
8. Auxilium Pharmaceuticals to Present at the Deutsche Bank 36th Annual Health Care Conference
9. Auxilium Pharmaceuticals, Inc. Announces Launch of XIAPEX® in EU by Pfizer
10. Auxilium Pharmaceuticals, Inc. and Asahi Kasei Pharma Corporation Enter Agreement to Develop, Commercialize and Supply XIAFLEX® In Japan
11. Auxilium Pharmaceuticals, Inc. Completes Enrollment of XIAFLEX® Phase III Double-Blind Studies for Peyronies Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/12/2017)... , May 12, 2017  The China and ... washing technology that consumes less water, energy and detergent, and features ... first product LaughingU, a shoebox-sized washing machine that washes and sanitizes ... ... Product, LaughingU, is compact, and does not require an external water ...
(Date:5/10/2017)... Global Health Intelligence (GHI), the leading healthcare data analytics ... 2017 ranking of the Best-Equipped Hospitals in Latin America ... GHI,s hospitals database for Latin America , which is ... database covers 86% of the hospitals in Latin ... each institution in key areas such as beds, medical specialties, ...
(Date:5/10/2017)... 2017 CSSi, the global leader in patient ... industry, is proud to announce the launch of its ... features both enriched content and a customized layout that ... company,s already well-established position as the top global patient ... many months of hard work, we are delighted to ...
Breaking Medicine Technology:
(Date:5/22/2017)... IL (PRWEB) , ... May 22, 2017 , ... ... is part of a larger group investing in InsightRX, an early stage company ... patient’s underlying biological and pharmacological characteristics. Greatpoint Ventures Innovation Fund acted ...
(Date:5/21/2017)... ... May 20, 2017 , ... GetLinked® software continues ... and financial systems. , Dozens of clubs using ABC Financial Services are now ... GetLinked into their club’s accounting system , The latest implementation is Riverside ...
(Date:5/21/2017)... ... May 21, 2017 , ... ... brought together a cross-disciplinary group of scholars, policymakers, and activists wanting to address ... and Equity is the third book from a recent series of from ...
(Date:5/21/2017)... ... ... Following the tragic and widely publicized death of Rory Staunton, 12, from ... follow a protocol to quickly identify and treat the condition. , The mandate ... have saved Rory or anyone else’s life. , Now, five years after the ...
(Date:5/19/2017)... ... 19, 2017 , ... A leader in higher education and ... recruitment efforts for the inaugural cohort of its online Master of Health ... to approach and address the unique nuances healthcare organizations face using a business-minded ...
Breaking Medicine News(10 mins):