Dublin, Ireland and Cambridge, MA, January 2, 2003 Elan Corporation, plc (NYSE: ELN) ("Elan") and Biogen, Inc. (NASDAQ: BGEN) ("Biogen") announce the publication of two clinical study reports on ANTEGREN (natalizumab) in today's issue of the New England Journal of Medicine. Natalizumab, a humanized monoclonal antibody, showed promising results on disease remission and improved quality of life for patients with Crohn's disease in an investigational study, according to results published today. Crohn's disease, a chronic, progressive and immune-related inflammatory disease of the gastrointestinal tract, can cause a range of debilitating symptoms such as severe diarrhea, crampy abdominal pain and malnutrition. Current treatment options for the disease are limited.
Crohn's Disease Study Design and Results
The randomized, double-blind, placebo-controlled, parallel group, Phase II study of 248 patients with Crohn's disease presented in the New England Journal of Medicine was conducted in eight countries at 35 clinical trial sites. Patients were randomized to one of four treatment groups: single 3 mg/kg natalizumab infusion followed by placebo (n=68); two 3 mg/kg natalizumab infusions at four-week intervals (n=66); two 6 mg/kg natalizumab infusions at four-week intervals (n=51), or placebo (n=63) and all groups were observed for at least 12 weeks following the first infusion. Patients with moderate- to-severe active Crohn's disease (Crohn's Disease Activity Index ("CDAI") scores of 220 to 450) were included in the study. The primary measure of effectiveness was clinical remission: a score of less than 150 on the CDAI. Clinical response was defined as a decrease of at least 70 points in the CDAI from baseline. Additional efficacy measures included quality of life assessments, as determined by the Inflammatory Bowel Disease Questionnaire ("IBDQ").
Although the primary endpoint of remission at 6 weeks in the 6 mg/kg dose group compared to placPage: 1 2 3 4 Related biology news :1
Contact: Amy Losak
. Clinical study results published in NEJM show promising data on Antegren (natalizumab)2
. Preclinical safety study shows adipose-derived stem cells improve heart function after heart attack3
. First clinical study of new pediatric croup vaccine shows safety, tolerability in adults4
. Innovative ceramic-on-metal hip replacements to undergo clinical trials5
. Early clinical treatment can halt progression of Alzheimers disease, UCI researchers find6
. Warren Pharmaceuticals publishes results of preclinical evaluation7
. Creation of the UK Clinical Research Collaboration will boost clinical trials in UK8
. Scientists characterize new breast tumor subtypes with poor clinical outcomes9
. Uncertainty in clinical tests raises health care costs10
. Vanderbilts John Oates wins clinical research award11
. Germany starts clinical development of a new tuberculosis vaccine