Auxilium Pharmaceuticals, Inc. today announced that the Company has received clearance from the U.S. Food and Drug Administration ("FDA") to resume its phase III clinical trials for XIAFLEX (clostridial collagenase for injection), in the treatment of Dupuytren’s contracture
MALVERN, PA, USA | August 16, 2007 | Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL) today announced that the Company has received clearance from the U.S. Food and Drug Administration ("FDA") to resume its phase III clinical trials for XIAFLEX (clostridial collagenase for injection), formerly referred to as AA4500, in the treatment of Dupuytren’s contracture. The Company will hold a conference call today, August 16, at 10:00 a.m. Eastern Time to discuss this news.
"We are delighted that we can resume our XIAFLEX phase III trials in Dupuytren’s contracture earlier than anticipated. We expect to begin enrolling patients into our pivotal trial within the next 30 days," said Armando Anido, Chief Executive Officer and President of Auxilium. "I would like to give a special thanks to our employees for their tireless efforts in making this achievement possible."
The Company plans to initiate a pivotal double-blind trial in the U.S., a double-blind trial in Australia, and two open label trials that along with previously conducted trials will serve as the basis for the Biologics License Application ("BLA") for marketing approval from the FDA.
The U.S. pivotal trial is a double-blind, randomized, placebo-controlled study of XIAFLEX involving 216 patients in at least 15 sites throughout the U.S. Patients in the study will be randomized on a 2:1 basis in favor of treatment with XIAFLEX. The primary endpoint of the study is to determine if XIAFLEX can reduce the contracture angle in metacarpophalangeal (MP) or proximal interphalangeal (PIP) joints to within 0 to 5 degrees of normal.
Upon completion of the double-blind trial in the U.S., all patients are eligible to enter a separate open-label extension study in which they will receive XIAFLEX if they were initially given placebo or have other affected joints that need treatment. All patients in these studies will be monitored for a minimum of 12 months following initial dosing for efficacy and safety parameters.
The Australian study is a double-blind, randomized, placebo-controlled study with an open-label extension that will enroll 60 patients. The design of this study is similar to that of the U.S. pivotal phase III trial and its open-label extension.
In addition to the double-blind studies and their open-label extensions, the Company plans to concurrently conduct two phase III open-label studies in approximately 440 patients. These studies will provide additional safety and efficacy data and will contribute to the safety database that is required for the BLA.
"As XIAFLEX is ultimately targeted for worldwide markets, we believe that it is very important to perform well-controlled clinical trials at sites inside and outside of the U.S.," said Dr. Jyrki Mattila M.D., Ph.D., Executive Vice President of R&D, Business Development and Technical Operations. "The Company is eager to raise global physician and patient understanding of the potential benefits of XIAFLEX."
With respect to the clinical program for XIAFLEX for the treatment of Dupuytren’s contracture, Auxilium expects to:
— complete enrollment in the pivotal U.S. trial and the Australian trial by the end of 2007;
— release top-line results from the double-blind phase III clinical trials in the second quarter of 2008; and
— file the BLA for approval of XIAFLEX by FDA in early 2009.
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 a thickening and shortening of the normal ligaments of the palm and fingers. 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 MP 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)
About Auxilium
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. XIAFLEX(TM) (clostridial collagenase for injection), formerly referred to as AA4500, is in phase III development for the treatment of Dupuytren’s contracture and is in phase II 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 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. Auxilium also has options to all indications using XIAFLEX for non-topical formulations. For additional information, visit http://www.auxilium.com.
SOURCE: AUXILIUM PHARMACEUTICALS, INC.
Post Views: 132
Auxilium Pharmaceuticals, Inc. today announced that the Company has received clearance from the U.S. Food and Drug Administration ("FDA") to resume its phase III clinical trials for XIAFLEX (clostridial collagenase for injection), in the treatment of Dupuytren’s contracture
MALVERN, PA, USA | August 16, 2007 | Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL) today announced that the Company has received clearance from the U.S. Food and Drug Administration ("FDA") to resume its phase III clinical trials for XIAFLEX (clostridial collagenase for injection), formerly referred to as AA4500, in the treatment of Dupuytren’s contracture. The Company will hold a conference call today, August 16, at 10:00 a.m. Eastern Time to discuss this news.
"We are delighted that we can resume our XIAFLEX phase III trials in Dupuytren’s contracture earlier than anticipated. We expect to begin enrolling patients into our pivotal trial within the next 30 days," said Armando Anido, Chief Executive Officer and President of Auxilium. "I would like to give a special thanks to our employees for their tireless efforts in making this achievement possible."
The Company plans to initiate a pivotal double-blind trial in the U.S., a double-blind trial in Australia, and two open label trials that along with previously conducted trials will serve as the basis for the Biologics License Application ("BLA") for marketing approval from the FDA.
The U.S. pivotal trial is a double-blind, randomized, placebo-controlled study of XIAFLEX involving 216 patients in at least 15 sites throughout the U.S. Patients in the study will be randomized on a 2:1 basis in favor of treatment with XIAFLEX. The primary endpoint of the study is to determine if XIAFLEX can reduce the contracture angle in metacarpophalangeal (MP) or proximal interphalangeal (PIP) joints to within 0 to 5 degrees of normal.
Upon completion of the double-blind trial in the U.S., all patients are eligible to enter a separate open-label extension study in which they will receive XIAFLEX if they were initially given placebo or have other affected joints that need treatment. All patients in these studies will be monitored for a minimum of 12 months following initial dosing for efficacy and safety parameters.
The Australian study is a double-blind, randomized, placebo-controlled study with an open-label extension that will enroll 60 patients. The design of this study is similar to that of the U.S. pivotal phase III trial and its open-label extension.
In addition to the double-blind studies and their open-label extensions, the Company plans to concurrently conduct two phase III open-label studies in approximately 440 patients. These studies will provide additional safety and efficacy data and will contribute to the safety database that is required for the BLA.
"As XIAFLEX is ultimately targeted for worldwide markets, we believe that it is very important to perform well-controlled clinical trials at sites inside and outside of the U.S.," said Dr. Jyrki Mattila M.D., Ph.D., Executive Vice President of R&D, Business Development and Technical Operations. "The Company is eager to raise global physician and patient understanding of the potential benefits of XIAFLEX."
With respect to the clinical program for XIAFLEX for the treatment of Dupuytren’s contracture, Auxilium expects to:
— complete enrollment in the pivotal U.S. trial and the Australian trial by the end of 2007;
— release top-line results from the double-blind phase III clinical trials in the second quarter of 2008; and
— file the BLA for approval of XIAFLEX by FDA in early 2009.
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 a thickening and shortening of the normal ligaments of the palm and fingers. 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 MP 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)
About Auxilium
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. XIAFLEX(TM) (clostridial collagenase for injection), formerly referred to as AA4500, is in phase III development for the treatment of Dupuytren’s contracture and is in phase II 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 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. Auxilium also has options to all indications using XIAFLEX for non-topical formulations. For additional information, visit http://www.auxilium.com.
SOURCE: AUXILIUM PHARMACEUTICALS, INC.
Post Views: 132
