Navigation Links
Auxilium Pharmaceuticals, Inc. Announces XIAFLEX(TM) Meets Primary Endpoint With Statistical Significance (p<0.001) in CORD I Pivotal Phase III Study for Dupuytren's Contracture
Date:6/3/2008

s demonstrate that MP joints generally respond better to treatment than PIP joints, and joints of lesser severity generally respond better than joints of higher severity," said Dr. Tony DelConte, Chief Medical Officer for Auxilium. "We believe these findings will be well-received by the physician and patient community who have expressed a desire to treat affected joints earlier than current surgical practice."

Pharmacokinetic Study Results

An open label study was conducted to assess the pharmacokinetics of a single injection of XIAFLEX in 16 subjects with Dupuytren's contracture. Nine patients with MP contractures and seven patients with PIP contractures were enrolled in the study. No measurable levels of XIAFLEX were detected in plasma from 5 minutes to 30 days post injection.

Although the study was not designed to measure efficacy in comparison to placebo, 12 of the 16 patients achieved < / = 5 degrees of normal contracture after their only injection of XIAFLEX.

Adverse Events

The most common adverse events reported in the CORD I and II and PK studies were pain, swelling, bruising and pruritis at the injection site and transient lymph node swelling and pain. These adverse events were consistent with previous trials. No systemic allergic reactions were noted.

In data from the CORD I and II studies, the open label JOINT I and II studies and the PK study, over 2,000 XIAFLEX injections have been administered to approximately 850 patients through the end of May 2008. There have been seven SAEs possibly related to drug (rate per injection = 0.33%). There have been a total of three confirmed tendon ruptures (rate per injection =0.14%), one reported tendon rupture remains unconfirmed (rate per injection = 0.05%), and one pulley ligament injury (rate per injection = 0.05%). Additionally, one complex regional pain syndrome (rate per injection = 0.05%) and one deep vein thrombosis ("DVT") (rate per injection = 0.05%) occurred. Three
'/>"/>

SOURCE Auxilium Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10 11

Related medicine technology :

1. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
2. Keryx Biopharmaceuticals, Inc. Announces Poster Presentation Highlighting Observed Clinical Activity of KRX-0401 (Perifosine) at the American Society of Clinical Oncology Meeting in Chicago, Illinois
3. Jazz Pharmaceuticals, Inc. Completes Enrollment in First of Two Phase III Clinical Trials of Sodium Oxybate to Treat Fibromyalgia
4. Arena Pharmaceuticals, Inc. Announces Initiation of Phase 1 Clinical Trial of Drug Candidate Under Partnership with Taisho Pharmaceutical Co., Ltd.
5. Alseres Pharmaceuticals, Inc. to Address a Congressional Briefing on Paralysis Research and the Spinal Cord Injury Community at Working 2 Walk in Washington, DC, April 13-15, 2008
6. Lotus Pharmaceuticals, Inc. Achieves Significant Milestones in the Development of Isosorbide Mononitrate Sustained Release Tablets
7. Jazz Pharmaceuticals, Inc. Announces Receipt of FDA Orphan Drug Designation for Recurrent Acute Repetitive Seizures Product Candidate
8. Solvay Pharmaceuticals, Inc. Responds to Advisory Committee Recommendation for Further Study of Tedisamil to Treat Atrial Fibrillation
9. Keryx Biopharmaceuticals, Inc. Announces Phase 1 and Phase 2 Data on KRX-0401 (Perifosine) in Patients with Relapsed/Refractory Multiple Myeloma at 49th Annual Meeting of American Society of Hematology
10. Quark Pharmaceuticals, Inc. Announces First Systemic siRNA Dosing in Humans
11. Keryx Biopharmaceuticals, Inc. Announces Positive Preliminary Phase 2 Data on KRX-0401 in Patients with Chemo-Insensitive Rare Sarcoma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/23/2014)... YORK , September 23, 2014 ... pioneer in computer-aided dysmorphology analysis will exhibit at the ... Diego, CA. FDNA will present the latest ... and reference solution, using facial analysis technology. Face2Gene facilitates ... of human malformations from facial photos. The ...
(Date:9/23/2014)... , Sept. 23, 2014  Medela announced today ... Biomedical Company (ABC), assigning Medela as the exclusive distributor ... known as the Medela Enteral Feeding Pump. Through this ... help NICU parents and healthcare professionals by offering a ... Medela Enteral Feeding Pump is integral to the delivery ...
(Date:9/23/2014)... N.J. , Sept. 23, 2014  Soligenix, ... late-stage biopharmaceutical company developing products that address unmet ... and biodefense, announced today that it has appointed ... President of Biopharmaceutical Development.  Dr. Arumugham has over ... and development (R&D) in the areas of formulation ...
Breaking Medicine Technology:FDNA to Exhibit at ASHG2014 Presenting Face2Gene Integrated With London Medical Databases (LMD) Online 2Medela Enters Exclusive Enteral Feeding Pump Agreement with Atlanta Biomedical Company 2Soligenix Appoints Rasappa Arumugham, PhD, as Vice President of Biopharmaceutical Development 2Soligenix Appoints Rasappa Arumugham, PhD, as Vice President of Biopharmaceutical Development 3Soligenix Appoints Rasappa Arumugham, PhD, as Vice President of Biopharmaceutical Development 4
... HbA1c reductions seen in ischemic patients with ... diabetes in earlier clinical trials -, ... ) announced today that data from a prospectively identified,analysis of ... (ranolazine extended-release tablets) significantly reduced,hemoglobin A1c (HbA1c), increased the number ...
... Cleveland Clinic Researchers Highlight the Need For More Women to ... ... Cleveland Clinic,researchers have recently found that women remain a significant ... and Blood Institute (NHLBI). Lead Author, Esther S.H. Kim, ...
Cached Medicine Technology:CV Therapeutics' Anti-Ischemic Agent Ranexa(R) Significantly Reduces HbA1c and Other Markers of Diabetes in MERLIN TIMI-36 2CV Therapeutics' Anti-Ischemic Agent Ranexa(R) Significantly Reduces HbA1c and Other Markers of Diabetes in MERLIN TIMI-36 3CV Therapeutics' Anti-Ischemic Agent Ranexa(R) Significantly Reduces HbA1c and Other Markers of Diabetes in MERLIN TIMI-36 4Enrollment of Women in Cardiovascular Trials Fails to Meet Current Federal Mandates 2
(Date:9/23/2014)... September 23, 2014 With summer at ... in spirit and weather), organic food manufacturing company Earth ... month centered on sweet treats for the whole family. ... bite-sized candies by the handful in celebration of the ... recent years these festivities come with an increasing degree ...
(Date:9/23/2014)... IL (PRWEB) September 23, 2014 ... solutions, has expanded its MedMaster™ M4 product line ... luminaire extends the M4 product line – currently ... LED options – providing more flexibility when designing ... the MedMaster M4 Series include:, •Three ...
(Date:9/23/2014)... On September 20- 21, 2014, people ... two days of Trivedi Retreat ‘Consciousness is Power’, online ... the Energy Transmissions from Mahendra Trivedi and Trivedi Masters™ ... people enjoyed the In-person, group and live Energy Transmissions ... Trivedi and Trivedi Master™ Alice Branton, where, they described ...
(Date:9/23/2014)... (HealthDay News) -- Pregnant women appear to have an ... a new study. And this strong immune ... from the flu than other healthy adults. The reason: ... immune system responding to the virus, the researchers said. ... that pregnancy weakens the immune system to keep it ...
(Date:9/23/2014)... On September 8th, the company XenOPAT SL, a spin-off ... Catalan Institute of Oncology (ICO) was established with the ... to the service combating cancer with two main branches: ... of personalized cancer treatments. , Orthotopic models and ... the use of orthotopic models (orthoxenograft) mouse by implantation ...
Breaking Medicine News(10 mins):Health News:Righteously Raw Chocolates Promote Healthy, Fun Snacking this Fall Season 2Health News:Kenall Expands MedMaster™ M4 Surgical Suite Product Portfolio with New 1'×4' Option 2Health News:Kenall Expands MedMaster™ M4 Surgical Suite Product Portfolio with New 1'×4' Option 3Health News:The Trivedi Retreat ‘Consciousness is Power’ was Huge Success 2Health News:The Trivedi Retreat ‘Consciousness is Power’ was Huge Success 3Health News:Study Suggests Why Pregnant Women Get Sicker From Flu 2Health News:Study Suggests Why Pregnant Women Get Sicker From Flu 3Health News:XenOPAT, mouse models for personalized cancer treatment 2
... ... ... ... ...
... ... ... ... ...
... ... ... , ... TULSA, Okla. , Feb. 19 U.S. ...
... more fumes that are likely carcinogenic than with electric ranges ... hot stove -- make that a hot gas ... cancer. , Researchers in Norway have found that cooking with ... , But, in a report published online Feb. 17 in ...
... (P4P) programs are payment models that reward workers for ... the healthcare setting, P4P programs use a variety of ... fee differentials and bonuses. A new study ... that P4P programs appear to be effective in incentivizing ...
... ... momentum created by local communities and the NGO Tostan to end the practice by 2015 ... Dakar, Senegal (PRWEB) February ... cutting (FGC) which has seen thousands of communities in Senegal join its ranks in recent ...
Cached Medicine News:Health News:New Gallup Poll Quantifies U.S. Physician Opinions on the Scope of Defensive Medicine Practices 2Health News:New Gallup Poll Quantifies U.S. Physician Opinions on the Scope of Defensive Medicine Practices 3Health News:New Gallup Poll Quantifies U.S. Physician Opinions on the Scope of Defensive Medicine Practices 4Health News:Abbott Announces 10 Percent Increase in Quarterly Dividend 2Health News:Abbott Announces 10 Percent Increase in Quarterly Dividend 3Health News:Two Tulsa Pharmacies Penalized for Missing Prescription Drugs 2Health News:Two Tulsa Pharmacies Penalized for Missing Prescription Drugs 3Health News:Gas Cooking Might Up Your Cancer Risk 2Health News:Gas Cooking Might Up Your Cancer Risk 3Health News:Senegal: Total End of Female Genital Cutting Now in Sight 2
... The 1700 Series Outpatient Surgical Table ... standards as Skytron's other specialty and general ... their key features such as 180-degree top ... extremely durable side rails will accommodate a ...
23" Top Slide with Full Table Functions for Every Procedure...
... operating table for any application. The ... unlimited C-arm access. High stability guarantees ... and cardiovascular procedures. An extension device ... can easily be attached for orthopedic ...
As with all Eschmann products the T20 operating table was designed with 'Simplicity and Intuitiveness' in mind, having drawn influences from leading clinicians of various levels from across the globe...
Medicine Products: