Navigation Links
Auxilium Pharmaceuticals, Inc. Announces First Patient Dosed in Phase 2b Frozen Shoulder Syndrome Study of Collagenase Clostridium Histolyticum
Date:12/13/2013

he triple helix collagen structure. XIAFLEX has been granted Orphan Drug Designation in the U.S. by the FDA for DC and PD.

 "The initiation of our Phase 2b Frozen Shoulder syndrome study represents another development milestone for Auxilium as we further evolve our pipeline and advance a fourth potential indication for CCH," explained Adrian Adams, Chief Executive Officer and President of Auxilium. "We believe that our continued measured investments in research and development, together with the upcoming product launches of XIAFLEX in Peyronie's disease and STENDRA™ in erectile dysfunction, position the Company well for growth and shareholder value creation."

The Phase 2b study is a double-blind, placebo-controlled study of the safety and efficacy of CCH for the treatment of Stage 2 (frozen stage) unilateral idiopathic FSS. The study will enroll approximately 300 adult men and women at approximately 35 sites in the U.S. and Australia. Subjects will be randomized 3:1 to receive CCH or placebo and will receive up to three ultrasound-guided injections of study drug. Each injection will be separated by a minimum of 21 days. All subjects will also perform home shoulder exercises after the first injection.

In a prior Auxilium Phase 2a FSS study, both the 0.58mg (1mL) and 0.58mg (2mL) dosing arms showed statistically significant improvement (p<0.05)  from baseline in forward flexion versus the exercise-only group. The 0.58mg (1mL) dosing arm also showed statistically significant improvement (p<0.05) from baseline in shoulder abduction versus the exercise-only group. For this Phase 2b study, the dose selected will be 0.58 mg (1mL). 

The Phase 2b study's primary endpoint is the change (degrees) from baseline to the Day 95 follow-up visit in active forward flexion in the affected shoulder compared to placebo. Patients will also be assessed using the Ameri
'/>"/>

SOURCE Auxilium Pharmaceuticals, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. Auxilium Pharmaceuticals to Present at the Deutsche Bank 37th Annual Healthcare Conference
2. Auxilium Pharmaceuticals to Announce First Quarter 2012 Results and Conduct Conference Call on Thursday, May 10, 2012
3. Auxilium Pharmaceuticals, Inc. to Present At The BofAML 2012 Health Care Conference
4. Auxilium Pharmaceuticals, Inc. and FCB I LLC Announce the Issuance of Composition of Matter Patent Covering Testim
5. Auxilium Pharmaceuticals, Inc. Raises Revenue Guidance And Reduces Net Loss Guidance For 2012
6. Auxilium Pharmaceuticals, Inc. to Present at the Goldman Sachs Global Healthcare Conference 2012
7. Auxilium Pharmaceuticals, Inc. Announces Second Quarter 2012 Financial Results
8. Auxilium Pharmaceuticals to Announce Third Quarter 2012 Results and Conduct Conference Call on Wednesday, November 7, 2012
9. Auxilium Pharmaceuticals, Inc. Announces Third Quarter 2012 Financial Results
10. Auxilium Pharmaceuticals, Inc. Announces Offering of Convertible Senior Notes Due 2018
11. Auxilium Pharmaceuticals, Inc. Announces Pricing of $325.0 Million of 1.50% Convertible Senior Notes Due 2018
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/30/2015)... , July 30, 2015 Vermillion, ... on gynecologic disease, announced today it will ... after the market close on Thursday, August ... call and webcast at 4:30pm Eastern.Conference Call ... at 4:30pm Eastern/1:30pm Pacific  Domestic: ...
(Date:7/30/2015)... 2015  NanoSmart Pharmaceuticals, Inc., a private pharmaceutical ... Orphan Drug Designation from the Food and Drug ... uses NanoSmart,s proprietary drug delivery platform. The drug ... treatment of Ewing,s sarcoma, a rare type of ... Drug Designation on the basis of a plausible ...
(Date:7/30/2015)... 2015 Flexpoint Ford, a private equity firm ... announced that it has entered into a partnership with ... to form Kastle Therapeutics, LLC (Kastle).  The new company, ... on acquiring, developing and commercializing pharmaceuticals targeted toward diseases ... select therapies already approved for marketing, as well as ...
Breaking Medicine Technology:NanoSmart Receives Second FDA Orphan Drug Designation for Treatment of Pediatric Cancer 2Flexpoint Ford Announces Partnership with Alan MacKenzie and Bryan Stuart to Form Kastle Therapeutics 2Flexpoint Ford Announces Partnership with Alan MacKenzie and Bryan Stuart to Form Kastle Therapeutics 3
... 22, 2011 United Seating & Mobility (USM) ... transaction with Central Kentucky Mobility (CKM) to acquire and merge ... for Lexington, Louisville, as well as central, eastern and southern ... team strengthens our position within a core market for us ...
... WOONSOCKET, R.I., July 22, 2011 CVS Caremark Corporation ... conference call on Thursday, August 4, 2011, at 8:30 ... second quarter 2011 financial results. (Logo: http://photos.prnewswire.com/prnh/20090226/NE75914LOGO) ... will be broadcast simultaneously through the Investor Relations portion ...
Cached Medicine Technology:CVS Caremark Corporation to Hold Second Quarter 2011 Conference Call 2
(Date:7/30/2015)... ... July 30, 2015 , ... ... Biz Report, which takes a look at small, medium, and large businesses making ... business expert, conducted the business review and shared with viewers how DevExpress has ...
(Date:7/30/2015)... ... July 30, 2015 , ... 24/7 Care At Home, a high-quality ... Bernardino, recently announced that the Centers for Medicare and Medicaid (CMS) have awarded its ... care providers. 24/7 Care At Home’s agency is one of three top Orange County ...
(Date:7/30/2015)... ... , ... The need for accessibility is never greater than when we find ... well as visiting friends and family during these critical moments, hospitals around the Pennsylvania ... powered by ChargeItSpot , a Philadelphia-based startup that recently secured a $4M Series ...
(Date:7/30/2015)... ... 2015 , ... OncLive®’s extensive roster of Strategic ... Cancer Center (JCCC) mutually agreed to collaborate on projects that promote groundbreaking ... groups will help spread the news about the center’s leading-edge cancer research, robust ...
(Date:7/30/2015)... ... 2015 , ... Zejax is a New Way of Training ... , World renown body weight trainer, Paul Ziachik, announces today that he ... a person’s training capability. , The American College of Sports Medicine states that ...
Breaking Medicine News(10 mins):Health News:Software to Develop High-Performance Data-Driven Apps was Featured on NewsWatch Television 2Health News:24/7 Care At Home Earns a 5-Star Rating from the Centers for Medicare and Medicaid (CMS) 2Health News:Hospitals Add Phone Charging Stations as an Amenity for Patients and Visitors 2Health News:UCLA Jonsson Comprehensive Cancer Center Teams with OncLive® as a Strategic Alliance Partner 2Health News:UCLA Jonsson Comprehensive Cancer Center Teams with OncLive® as a Strategic Alliance Partner 3Health News:UCLA Jonsson Comprehensive Cancer Center Teams with OncLive® as a Strategic Alliance Partner 4Health News:Zejax is a Revolutionary New Way of BodyWeight Training Without Weights 2
... April 12 (HealthDay News) -- A new study finds that ... spending, which is more than twice as high as previous ... to prevent obesity, said the researchers from Cornell University in ... medical costs are $2,741 a year higher (in 2005 dollars) ...
... Toxoplasma gondii parasite, the cause of ... birth defects in the United States. The researchers used a ... of Allergy and Infectious Diseases (NIAID), part of the National ... that children acquire from their acutely infected mothers while in ...
... , Chapel Hill, NC In a paper published today ... University of North Carolina at Chapel Hill unveils the first ... measurement of the mechanism behind drug-resistant cancer and rational prediction ... in human tissues that play a key role in cell ...
... THURSDAY, April 12 (HealthDay News) -- More unmarried women who ... a new government report shows. Twenty-seven percent of births ... threefold increase from 1985, researchers from the U.S. Centers for ... births outside of marriage, one parent isn,t present. But our ...
... order to accurately identify skulls as male or female, ... how the characteristics of male and female skulls differ ... University shows that these differences can be significant, even ... The researchers looked at the skulls of 27 ...
... People who have Huntington,s disease are much less likely to ... a new study that suggests the diseases share a common ... Huntington,s had a 53 percent lower risk of being diagnosed ... Huntington,s disease, the lower cancer risk applies to the other ...
Cached Medicine News:Health News:Test links strains of common parasite to severe illness in US newborns 2Health News:Test links strains of common parasite to severe illness in US newborns 3Health News:Kinase test may yield big gains for drug-resistant cancers 2Health News:More Unmarried Couples Having Babies: CDC 2Health News:Study finds significant skull differences between closely linked groups 2Health News:Huntington's Disease Linked to Reduced Cancer Risk in Study 2
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: