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:8/29/2014)... Ore. , Aug. 29, 2014 /PRNewswire-iReach/ -- ... Accessory (Axilla) Strap for the SAM Junctional Tourniquet.  ... SAM Medical Products announced today ... voluntary recall to address a potential issue with ... used for the Axilla application of the SAM ...
(Date:8/29/2014)... PLEASANTON, Calif. , Aug. 29, 2014 ... leader in device-based mechanical circulatory support therapies to save, ... be participating in the 2014 Morgan Stanley Global Healthcare ... F. Burbach , President and Chief Executive Officer, will ... p.m., Eastern Daylight Time (9:55 a.m., Pacific Daylight Time). ...
(Date:8/29/2014)... , August 29, 2014 ... Oil Market by Extraction type (SFE, Cold Pressed, ... Personal Care, Pharmaceutical, Food Supplements, Fragrance, & Others) - ... MarketsandMarkets, defines and segments the Amaranth Seed Oil ... market size in terms of value. The Amaranth ...
Breaking Medicine Technology:SAM Medical Products Implements Voluntary Recall of its Accessory (Axilla) Strap for the SAM Junctional Tourniquet. 2Amaranth Seed Oil Market worth $700.6 Million by 2019 2Amaranth Seed Oil Market worth $700.6 Million by 2019 3Amaranth Seed Oil Market worth $700.6 Million by 2019 4
... The two most,prevalent forms of genetic mental retardation, ... cause, according to researchers at,Stanford University School of ... brain, may also be associated with,autism., Although the ... result for the brain seems to be the ...
... YORK--(BUSINESS WIRE)--Apr 12, 2007 - INNOVIVE Pharmaceuticals,Inc. ... of INNO-406, a potent oral dual Bcr-Abl ... leukemia, will be presented at the American ... takes place April,14-18, 2007 at the Los ...
Cached Medicine Technology:Fragile X, Down Syndromes Linked to Faulty Brain Communication,Stanford Researcher Finds 2Fragile X, Down Syndromes Linked to Faulty Brain Communication,Stanford Researcher Finds 3Fragile X, Down Syndromes Linked to Faulty Brain Communication,Stanford Researcher Finds 4Innovive Pharmaceuticals Announces Additional Data Presentations at,American Association for Cancer Research Annual Meeting 2
(Date:8/30/2014)... A new batteryless cardiac pacemaker based on an ... presented at ESC Congress 2014 today by Adrian ... require battery replacement. , Mr Zurbuchen, a PhD ... University of Bern, Switzerland, said: "Batteries are a ... reach a critically low energy level, physicians see ...
(Date:8/30/2014)... Malden, MA (PRWEB) August 31, 2014 In ... ‘dog eat dog’ approach, Karma Web Group, LLC launches a ... iOS and Android the newly launched Ultimate Karma app is ... rewarded with new levels of play, the game pulls double-duty ... at the same time. , Designed to reward gamers for ...
(Date:8/30/2014)... Atlanta, GA (PRWEB) August 31, 2014 ... across their dealerships to help raise money and awareness ... Bucket Challenge. , General Managers, staff, and even Vice ... was captured on film and can be viewed on ... to participating in the challenge, general managers and staff ...
(Date:8/30/2014)... (PRWEB) August 30, 2014 The Truth about ... body that will reveal to users some shocking foods that ... great results in modeling looks, as well as some motivation ... method says that there is one unique trick that can ... indicates that despite what many people might think, cardio exercise ...
(Date:8/30/2014)... 2014 Ticket Down reports that ticket ... match next Saturday at Levi's Stadium. The summer months ... in the United States due to the fact that so many ... major city. Many of these games were practice games in ... summer. , Levi’s Stadium is a brand new facility that will ...
Breaking Medicine News(10 mins):Health News:Batteryless cardiac pacemaker is based on automatic wristwatch 2Health News:Newly Launched Ultimate Karma App Elicits Happiness in Players and Encourages Moral Values 2Health News:Jim Ellis Automotive Group Take the ALS Ice Bucket Challenge 2Health News:Truth about Six Pack Abs Review Reveals Unique Method to Eliminate Stubborn Stomach Fat 2Health News:Mexico vs. Chile Tickets at Levi's Stadium in Santa Clara, CA: TicketDown.com Offers Promo Code for Mexico vs. Chile Exhibition Game on September 6th 2
... Survey Reveals Favorite and Least Favorite Body Parts: ... Jan. 21 Faces and abs top the list ... both men and women, according to a new survey ... non-invasive aesthetic services in the U.S.Nearly a quarter of ...
... for 2009 , ... (Vocus) January 21, 2009 -- ... 2009 according to recent predictions made by the leadership of the ... prediction: a continued growth in consumers who elect to enhance ...
... Jan. 21 Senator Sam Brownback and Rep. ... Council,s Blogs for Life, on ... also feature several prominent conservative voices including Amanda ... Ph.D., Michael Illions, Peter Shinn, Chris Gacek, J.D., ...
... Health Plan Outperforms National Medicaid Plans on Key ... Health Plan (SFHP), the City,s community health plan, ... U.S. leader in childhood immunizations for Medicaid health ... are fully immunized, besting second-ranked Kaiser Permanente of ...
... have different reproductive plans, lifestyles, religious prohibitions, and ... contraceptive choices available, can make selecting the right ... of appropriate and acceptable contraceptive methods can improve ... pregnancy. To address this issue, OBG Management ...
... BALTIMORE, Jan. 21 Physicians Practice and Tucson Medical ... and their staff more time to devote to patient ... to help doctors in the southern Arizona area better ... busy practice. Through this new alliance, Tucson Medical Center ...
Cached Medicine News:Health News:How Does Our Vanity Fare? 2Health News:Cosmetic Injections A Worthwhile Investment 2Health News:Cosmetic Injections A Worthwhile Investment 3Health News:Cosmetic Injections A Worthwhile Investment 4Health News:Senator Sam Brownback and Rep. Cathy McMorris Rodgers to Speak at Blogs for Life 2009 2Health News:San Francisco Health Plan is U.S. Leader in Childhood Immunizations 2Health News:San Francisco Health Plan is U.S. Leader in Childhood Immunizations 3Health News:Physicians Practice and Tucson Medical Center Partner to Improve Patient Care in Southern Arizona 2Health News:Physicians Practice and Tucson Medical Center Partner to Improve Patient Care in Southern Arizona 3
... single-use products to promote safety for your ... catheter reduces cross-contamination and helps protect your ... because cleaning is eliminated, you have more ... water perfused manometric catheters for esophageal, anorectal ...
Esophageal Stylet for LATITUDE® Air-Charged Catheter...
Replacement Stopper for LATITUDE® Air-Charged Catheter...
Manometric Calibration System for LATITUDE® Air-Charged Catheter...
Medicine Products: