Navigation Links
New Phase 3 Study Results Show REMICADE® is Effective in the Treatment of Pediatric Patients With Moderate to Severe Ulcerative Colitis
Date:5/9/2011

CHICAGO, May 9, 2011 /PRNewswire/ -- Data from a Phase 3 randomized, multicenter, open-label study demonstrated clinical response with REMICADE® (infliximab) in the treatment of pediatric patients with moderately to severely active ulcerative colitis (UC), and showed a safety profile consistent with previous clinical trials conducted in an adult population.  The pediatric UC findings, presented today at Digestive Disease Week, showed REMICADE induced clinical response in 73 percent of patients aged 6-17 years at week 8, the primary endpoint of the trial.  REMICADE received U.S. Food and Drug Administration (FDA) approval for the treatment of adults with moderately to severely active UC in September 2005 and in October 2006, REMICADE received FDA approval for maintaining clinical remission and mucosal healing indications in adults living with UC.

UC is a chronic inflammatory bowel disease (IBD) of the colon.  It is estimated that 1.4 million Americans have IBD with the number evenly split between UC and Crohn's disease.  An estimated 150,000 children under age 17 are living with debilitating symptoms of IBD.(1)  

"The results of this study are consistent with findings from the Active Ulcerative Colitis (ACT) trials, which evaluated REMICADE in the treatment of adults with ulcerative colitis," said Jeffrey Hyams, Head of the Division of Digestive Diseases and Nutrition at Connecticut Children's Medical Center and Professor of Pediatrics at University of Connecticut School of Medicine, and lead study investigator.  "UC can be a devastating disease, particularly for children and adolescents.  It is encouraging to see such promising results in a patient population that is in need of additional treatment options."

In December 2010, Centocor Ortho Biotech Inc. submitted a supplemental Biologics License Application (sBLA) to the FDA requesting the approval of REMICADE (infliximab) for the treatment of modera
'/>"/>

SOURCE Centocor Ortho Biotech Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related biology technology :

1. Merrimack Pharmaceuticals Initiates Enrollment in a Phase 1 Study of MM-121, an ErbB3 Antagonist
2. BioMS Medical announces positive interim analysis on phase III trial of dirucotide (MBP8298) for multiple sclerosis
3. Dendreon Initiates Second of Two New Phase 2 Trials of PROVENGE for Prostate Cancer
4. Palatin Technologies, Inc. Reports Positive Results of Phase 2a Clinical Study with PL-3994 for the Treatment of Heart Failure
5. Logical Therapeutics Inc. Announces Results of Phase 1b Clinical Study of its Naproxen Prodrug
6. PTC124 Shows Promising Activity in Cystic Fibrosis; Phase 2 Proof-of-Concept Data Published in the Lancet
7. NovaRx Initiates Pivotal Phase III Clinical Trial in Lung Cancer Patients
8. Michigan Innovation Equipment Depot Launches Next Phase of Distribution
9. Phase 1b/2a Program Commences for RVX-208
10. Chiltern Early Phase: Fully Integrated and Business Ready
11. Oncolytics Biotech Inc. Announces U.S. Phase 2 Combination Clinical Trial for Non-Small Cell Lung Cancer Patients with K-RAS or EGFR-Activated Tumours
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2014)... at NYU Langone Medical Center have found a way ... for turning adult cells into so-called pluripotent stem cells ... the new technique in mice, the researchers increased the ... by more than 20-fold compared with the standard method. ... thus should generally accelerate research aimed at using stem ...
(Date:9/19/2014)... , Sept. 19, 2014  An entire month ... of inherited neuropathies – Charcot-Marie-Tooth disease (CMT) – a ... legs, causing extreme muscle atrophy, weakness, and foot and ... US and millions worldwide. CMT is a progressive disease, ... their legs, requiring mobility devices such as leg braces, ...
(Date:9/19/2014)... SAN DIEGO , Sept. 19, 2014 ... engaged in the development of high-value and difficult to ... will be presenting at the 21 st Annual ... New York . Bertrand Liang , chief ... the company,s development programs and business strategy on Friday, ...
(Date:9/19/2014)... September 19, 2014 Cereal grain ... industries will gather October 5–8, 2014, for the ... Island Convention Center in Providence, Rhode Island. The ... work of food scientists, chemists, microbiologists, nutritionists, and ... food production management. To date, 1,000 attendees have ...
Breaking Biology Technology:NYU Langone scientists report reliable and highly efficient method for making stem cells 2NYU Langone scientists report reliable and highly efficient method for making stem cells 3September is Charcot-Marie-Tooth (CMT) Awareness Month - Scheduled events, activities and important partnerships announced throughout the month! 2Pfenex to Present at Upcoming Industry Conference on September 26 2Latest Research on Cereal Grain Quality, Health Benefits and Food Production to be Presented During the AACC International Annual Meeting 2Latest Research on Cereal Grain Quality, Health Benefits and Food Production to be Presented During the AACC International Annual Meeting 3
... At the Boston Atrial,Fibrillation Symposium, Stereotaxis, Inc. (Nasdaq: ... remote magnetic ablation that it believes will enhance ... Navigation,System. In booth #917, Stereotaxis will exhibit ... Cardiodrive(R) System for enhanced remote,catheter control and improved ...
... 14 In meetings held in association,with the JP ... (Nasdaq and MTA: CTIC) reviewed 2009 targeted milestones and ... approvals in 2009 in,addition to potential label expansion for ... Spectrum Pharmaceuticals, Inc.,(Spectrum) for Zevalin. , ...
... At the end of December,Trinitas Comprehensive Cancer Center ... state of New Jersey to offer cancer patients treatment ... VAR ).,RapidArc is a fast, precise form of ... is possible with conventional radiation therapy,technologies. By delivering ...
Cached Biology Technology:Stereotaxis Showcases Advancements for Remote Magnetic Ablations 2Stereotaxis Showcases Advancements for Remote Magnetic Ablations 3Stereotaxis Showcases Advancements for Remote Magnetic Ablations 4Cell Therapeutics Targeting Potential Zevalin Label Expansion, Pixantrone and OPAXIO Drug Approvals to Grow Commercial Operations and Revenues in 2009 2Cell Therapeutics Targeting Potential Zevalin Label Expansion, Pixantrone and OPAXIO Drug Approvals to Grow Commercial Operations and Revenues in 2009 3Cell Therapeutics Targeting Potential Zevalin Label Expansion, Pixantrone and OPAXIO Drug Approvals to Grow Commercial Operations and Revenues in 2009 4Cell Therapeutics Targeting Potential Zevalin Label Expansion, Pixantrone and OPAXIO Drug Approvals to Grow Commercial Operations and Revenues in 2009 5Cell Therapeutics Targeting Potential Zevalin Label Expansion, Pixantrone and OPAXIO Drug Approvals to Grow Commercial Operations and Revenues in 2009 6Trinitas Comprehensive Cancer Center Now Offering Cancer Patients Faster, Ultra-Precise Radiation Using New RapidArc Technology 2Trinitas Comprehensive Cancer Center Now Offering Cancer Patients Faster, Ultra-Precise Radiation Using New RapidArc Technology 3
(Date:9/18/2014)... novel robotic system that can operate inside the bore ... part of a biomedical research partnership program at Brigham ... determining if the robot, in conjunction with real-time MRI ... less costly, and less discomforting for the patient. The ... cancer therapies with greater precision. , Developed by a ...
(Date:9/18/2014)... acquire and creatively manipulate spoken language is unique to ... 6 million years of human evolution to make this ... candidate gene we now have," says Wolfgang Enard, Professor ... efforts to understand the molecular biological basis of language ... results of his latest study, undertaken in collaboration with ...
(Date:9/18/2014)... generally seem to be cheerful, happy-go-lucky characters, so you ... on life. , In fact some dogs are ... of Sydney shows. , "This research is exciting ... dogs objectively and non-invasively. It offers researchers and dog ... how that changes," said Dr Melissa Starling, from the ...
Breaking Biology News(10 mins):Trial begins for MRI-compatible robot designed to improve accuracy of prostate biopsies 2Trial begins for MRI-compatible robot designed to improve accuracy of prostate biopsies 3Trial begins for MRI-compatible robot designed to improve accuracy of prostate biopsies 4Trial begins for MRI-compatible robot designed to improve accuracy of prostate biopsies 5Language evolution: Quicker on the uptake 2Language evolution: Quicker on the uptake 3Dogs can be pessimists too 2Dogs can be pessimists too 3
... fossil fuel air pollution in the United States by ... , This novel way to measure carbon dioxide produced ... atmospheric scientists better understand where pollution is located and ... fossil-fuel-emitted carbon dioxide will be important as countries throughout ...
... used to help steady buildings against earthquakes, according to ... loose, sandy soil into rock. , When a major ... with disastrous consequences for buildings sitting on them. Currently, ... bind loose grains together. But these epoxy chemicals may ...
... Friedreich's ataxia is one of those diseases few have heard ... individual -- usually a child or teenager -- it is ... arms and legs, vision impairment and slurred speech, but eventually ... to heart failure later in life. There is no cure ...
Cached Biology News:Scientists map air pollution using corn grown in US fields 2Moonlighting enzyme linked to neurodegenerative disease 2Moonlighting enzyme linked to neurodegenerative disease 3
... Molecular Probes is pleased to ... for the ultrasensitive detection of primary ... at Indiana University, the ATTO-TAG reagents ... o-phthaldialdehyde (OPA), naphthalene-2,3-dicarboxaldehyde (NDA) and anthracene-2,3-dicarboxaldehyde, ...
...
Human Cystatin A MAb (Clone 224705)...
Corticoliberin...
Biology Products: