Navigation Links
Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
Date:8/19/2007

Conference Call Scheduled for 10:00 a.m. today, Thursday, August 16, 2007

MALVERN, Pa., Aug. 16 /PRNewswire-FirstCall/ -- 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 tria
'/>"/>

SOURCE Auxilium Pharmaceuticals, Inc.

Copyright©2007 PR Newswire.

Page: 1 2 3 4 5 6

Related medicine technology :

1. Auxilium Pharmaceuticals to Present at the 2007 CEUT Emerging Growth Opportunities Conference
2. Auxilium Announces New Data That Show Total Testosterone Blood Levels Increase Significantly Following Switch from AndroGel(R) to Testim(R)
3. Keryx Biopharmaceuticals, Inc. Announces Positive Phase I and Phase II Data on KRX-0401 in Patients with Relapsed/Refractory Multiple Myeloma and Waldenstroms Macroglobulinemia
4. Keryx Biopharmaceuticals, Inc. Announces Poster Presentations Highlighting Mechanism of Action and Clinical Activity of Sulonex(TM) (sulodexide oral gelcap) at the Upcoming American Diabetes Association 67th Scientific Sessions in Chicago, Illinois
5. Molecular Insight Pharmaceuticals, Inc. Presents Preclinical Data on Molecular Imaging Pharmaceutical for Prostate Cancer
6. Molecular Insight Pharmaceuticals, Inc. Presents Preclinical Data at Society Of Nuclear Medicine 2007 Annual Meeting
7. CytRx Announces RNAi Delivery Nanoparticle Technology Exclusively Licensed to Subsidiary, RXi Pharmaceuticals, Described in Peer-Reviewed Journal
8. Sirion Therapeutics Receives Orphan Drug Designation for Ophthalmic Drug to Treat Viral Eye Infection
9. Protalix BioTherapeutics, Inc. Receives Approval from the FDA to Initiate a Phase III Clinical Trial of prGCD
10. DUSA Pharmaceuticals Receives Orphan Drug Desi gnation for Levulan PDT to Treat Esophage al Dysplasia
11. Gloucester Pharmaceuticals Receives Fast Track Designation for Romidepsin in Peripheral T-Cell Lymphoma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... 2014 ResMed (NYSE: RMD ) today ... Chinese medical device manufacturer BMC Medical Co., Ltd. ... masks listed below infringe ResMed,s patents, and entered an order ... the United States : , ... , Willow nasal pillows mask , iVolve full face ...
(Date:12/24/2014)...   Assurex Health, a personalized medicine company ... for behavioral health and chronic pain conditions, today ... equity financing from new and existing investors, according ... Chief Executive Officer. The financing will ... Health,s GeneSight ®  products.  GeneSight,s patented ...
(Date:12/24/2014)... China , Dec. 23, 2014 ... pharmaceutical company that specializes in patented biopharmaceutical, modernized ... pharmaceutical ingredients (API) today announced that the Company ... its Good Manufacturing Practice (GMP) certificate of TPI,s ... Drug Administration,s (CFDA). The public notice period is ...
Breaking Medicine Technology:ResMed Wins Patent Infringement Lawsuit Against Chinese Manufacturer BMC Medical 2Assurex Health Secures $30 Million Financing Round to Continue Growth in Neuropsychiatric Pharmacogenomics 2Assurex Health Secures $30 Million Financing Round to Continue Growth in Neuropsychiatric Pharmacogenomics 3Assurex Health Secures $30 Million Financing Round to Continue Growth in Neuropsychiatric Pharmacogenomics 4TPI QLF Achieved Public Notice Status of GMP Certification 2TPI QLF Achieved Public Notice Status of GMP Certification 3
... 24 Mardil, Inc. today announced positive interim data from ... novel cardiac device - BACE (Basal Annuloplasty of the Cardia ... condition arises when the heart,s mitral valve leaks blood backward ... symptoms. , , The first 11 ...
... FRAZER, Pa., Sept. 24 Cephalon, Inc. (Nasdaq: ... (FDA) has granted a priority review for its supplemental New ... filed in June of this year. The FDA decision ... in patients with excessive sleepiness associated with jet lag disorder ...
Cached Medicine Technology:Mardil, Inc. Announces Positive Preliminary Results of Pilot Study With BACE(TM) Device at Annual TCT Conference 2Mardil, Inc. Announces Positive Preliminary Results of Pilot Study With BACE(TM) Device at Annual TCT Conference 3Cephalon Announces that FDA Grants Priority Review of its Supplemental New Drug Application for NUVIGIL as a Treatment for Excessive Sleepiness Associated with Jet Lag Disorder 2Cephalon Announces that FDA Grants Priority Review of its Supplemental New Drug Application for NUVIGIL as a Treatment for Excessive Sleepiness Associated with Jet Lag Disorder 3Cephalon Announces that FDA Grants Priority Review of its Supplemental New Drug Application for NUVIGIL as a Treatment for Excessive Sleepiness Associated with Jet Lag Disorder 4
(Date:12/26/2014)... DW-InductionHeating.com (DaWei Induction Heating Co.) is a ... producing and marketing of a series of induction heating ... new series of induction brazing equipments . , ... induction brazing refers to the joining of two ... heat. The manager says that there are fundamental differences ...
(Date:12/25/2014)... (PRWEB) December 26, 2014 The ... Analysis to 2023” focuses on the current treatment ... in the colorectal cancer market. Stivarga is a ... colon or rectal cancer. Boehringer Ingelheim is developing ... the treatment of refractory CRC in the US, ...
(Date:12/25/2014)... Dylan Queen, a famous online company supplying women’s special ... prom dresses, most of which are priced under $200. ... the promotion is valid until Jan. 22, 2015; the ... market. , The prom dresses in this new collection ... strapless, empire strapless chiffon, one shoulder, floor-length, V-neck beading, ...
(Date:12/25/2014)... (PRWEB) December 25, 2014 When head lice ... themselves in a frenzy to get rid of it while ... families in Coral Gables now have the solution right in ... salon clinic location, Lice Troopers provides full spectrum head lice ... Coral Gable area, including Sunset, Key Biscayne, Brickell, Coconut Grove, ...
(Date:12/25/2014)... (HealthDay News) -- Among early stage breast cancer patients ... of one percent will eventually develop leukemia as a ... The finding comes from a review of more than ... and it suggests that the risk for developing treatment-related ... previously thought. "The frequency of bone marrow cancers ...
Breaking Medicine News(10 mins):Health News:Induction Brazing Equipment Series From DaWei Induction Heating Co., A Reliable Supplier Of Induction Heating Equipment 2Health News:Nintedanib Colorectal Cancer Market Analysis and Forecast to 2023 Report at RnRMarketReserach.com 2Health News:Nintedanib Colorectal Cancer Market Analysis and Forecast to 2023 Report at RnRMarketReserach.com 3Health News:Nintedanib Colorectal Cancer Market Analysis and Forecast to 2023 Report at RnRMarketReserach.com 4Health News:Dylan Queen: Cheap Prom Dresses for the UK Market 2Health News:Coral Gables Florida Gets Ready to Be Lice-Free with Lice Troopers 2Health News:Breast Cancer Chemo Tied to Small But Significant Leukemia Risk 2Health News:Breast Cancer Chemo Tied to Small But Significant Leukemia Risk 3
... HARBIN, China, April 3 /PRNewswire-Asia-FirstCall/ -- SOKO Fitness & ... Opening of Xinyang,Spa in Harbin, Northeast China, on April ... on December 1, 2008 and has signed up more,than ... Xinyang Spa is located inside the Blessing ...
... University Hospital,s ventricular assist device program has earned ... quality. Ventricular assist devices (VAD) are mechanical pumps ... patients either await a heart transplant, or for ... option."Hahnemann sought accreditation for our VAD program because ...
... at Hahnemann University Hospital has been granted a Three-Year ... of the American College of Surgeons (ACoS). The Cancer ... evaluation by a physician surveyor. Approval by the CoC ... committed to providing the highest level of quality cancer ...
... recognize reporting that has enhanced public understanding of ... Biomedical Research (FBR) announced today it is accepting ... Journalism Awards. The awards, named after FBR,s ... journalists whose reporting has enhanced public understanding of ...
... AstraZeneca (NYSE: AZN ) is aware that ... posted to its web site -- and subsequently removed ... Drugs Advisory Committee (PDAC) meeting. The PDAC meeting is ... in supplemental new drug applications (sNDA) for SEROQUEL XR(R) ...
... neurological disorder, researchers say , , FRIDAY, April 3 (HealthDay ... for important insights into multiple sclerosis and other afflictions ... While looking into why pregnant cats on a ... with movement, including paralysis and vision, University of Wisconsin-Madison ...
Cached Medicine News:Health News:SOKO Fitness & Spa Group, Inc. Opens Xinyang Spa in Harbin 2Health News:Hahnemann University Hospital Awarded Certification From the Joint Commission for Ventricular Assist Devices 2Health News:Hahnemann University Hospital Receives Approval From The Commission on Cancer 2Health News:Foundation for Biomedical Research Announces Michael E. DeBakey Journalism Awards 2Health News:FDA Advisory Committee Documents for SEROQUEL XR Available on AstraZeneca Web Site 2Health News:FDA Advisory Committee Documents for SEROQUEL XR Available on AstraZeneca Web Site 3Health News:FDA Advisory Committee Documents for SEROQUEL XR Available on AstraZeneca Web Site 4Health News:FDA Advisory Committee Documents for SEROQUEL XR Available on AstraZeneca Web Site 5Health News:Cat Food-Linked Illness Yields Clues to MS 2
Disposable Cannula Cuffed Tracheostomy Tubes...
... Adult TRACH CARE Elbow ... intubated patients. Rounded edges ... smooth surface interface. Features ... thumb port. Offers multiple ...
... Irri-Cath® catheters help decrease the need ... alternative to fiber-optic bronchoscope for bronchial ... in opportunistic infections., ,All Portex® ... ,The Irri-Cath® suction system ...
... Maxi-Flo® suction catheters ... or straight. , ... catheter kits are latex-free., ... feature a catheter tip ...
Medicine Products: