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| |  DDW: Antegren (Natalizumab) Looks Promising For Crohn's Disease ATLANTA, GA -- May 23, 2001 -- Antegren® (natalizumab), a humanized monoclonal antibody, demonstrated promising results on multiple endpoints in a Phase II study of Crohn's Disease, a chronic inflammatory disease of the gastrointestinal tract, according to data presented today at an annual meeting of the American Gastroenterological Association during Digestive Disease Week, the premiere international meeting for the gastroenterology community. Elan Corporation, plc and Biogen, Inc. are collaborating on the development, manufacture and marketing of Antegren, one of the first in a new class of potential therapeutics known as alpha 4 integrin inhibitors that are designed to prevent migration of inflammatory cells from blood vessels to the site of inflammation. In addition to its potential as a treatment for Crohn's Disease, Antegren has also been evaluated in a Phase II multiple sclerosis (MS) study. The primary endpoint of the study was to show a statistically significant reduction in new gadolinium enhancing MRI brain lesions versus placebo. Elan and Biogen are extremely pleased with the findings from the study. The companies expect to present the Phase II MS data later this year at an appropriate scientific forum. Elan and Biogen met with the Food and Drug Administration (FDA) last week to discuss the design of the Phase III studies in MS that are expected to start later this year. This Phase II study (CD 202) enrolled 244 moderate-severely active patients with Crohn's Disease (Crohn's Disease Activity Index [CDAI] score 220-450). The randomized, double-blind, placebo-controlled, parallel group study was conducted across eight countries at 38 sites. The patients were randomized to one of four treatment groups: a single 3mg/kg Antegren infusion; two 3mg/kg Antegren infusions at a four-week interval; two 6mg/kg Antegren infusions at a four-week interval; or placebo. Patients were followed for 12 weeks following the first infusion and were assessed using the CDAI and changes in quality of life, as assessed by the Inflammatory Bowel Disease Questionnaire ("IBDQ"). A statistically significant difference in clinical response (decrease of >70 points in CDAI) was noted as early as week two and was maintained through week 12 with a maximal response of 74 percent in the 3mg/kg dose group versus 38 percent in the placebo group. Remission, defined as a CDAI score of <150, was achieved by 46 percent of patients in the 3mg/kg dose group versus 27 percent in the placebo group. There was also a statistically significant difference in the change from baseline IBDQ score in patients receiving two infusions of Antegren as compared to those receiving placebo In this trial Antegren was generally well tolerated. Data suggests that the most common adverse events reported were headache and abdominal pain. There were no notable differences among treatment groups in the number of patients Elan and Biogen met with the FDA last week to discuss the Phase III Crohn's Disease studies, which are designed to assess both the short-term treatment of active Crohn's Disease and to assess the long-term durability of responses with Antegren. The companies expect to start Phase III studies in Crohn's Disease later this year. "Many existing therapies have problematic side-effects, or have questions concerning safety with long-term use; therefore, other therapies are needed to treat this disease," said the study's lead investigator, Paul Rutgeerts, MD, PhD, FRCP, Professor of Medicine and Head of the Department of Endoscopy, Universitaire Ziekenhuizen Leuven, Belgium. "The Phase II data are exciting because they show, for the first time, that this novel humanized monoclonal antibody may provide an effective treatment to induce remission and maintenance of Crohn's Disease. We look forward to Phase III studies to learn more about this promising new drug." Approximately one million people worldwide have Crohn's Disease, a chronic inflammatory relapsing-remitting disease of the GI tract, which commonly affects both men and women. The onset of disease is in young adulthood. The disease usually causes diarrhea, crampy abdominal pain, often fever, and at times rectal bleeding. Loss of appetite and subsequent weight loss also may Complications include narrowing of the intestine, obstruction, abscesses, and fistulas (abnormal channels connecting the intestine and other organs, including the skin), malnutrition and decreased growth rate in children. Patients with Crohn's Disease fluctuate between periods of active disease and remission. The disease can result in frequent hospitalizations - 70 percent of patients will undergo surgery at least once, and 30 percent will need additional operations. A recent study has estimated that the total annual cost of Crohn's Disease in the United States exceeds $1.7 billion. "Antegren's unique therapeutic pathway may be a truly innovative approach for potential treatment of this disease," said Stephen Hanauer, MD, Professor of Medicine and Clinical Pharmacology, Director, section of Gastroenterology and Nutrition, the University of Chicago Hospitals and Health System. "What is particularly exciting about this study is that results were seen as early as the second week of follow-up." "Crohn's Disease is a serious, chronic disease that can severely impact a patient's life," added William J. Sandborn, MD, Professor of Medicine, Mayo Medical School, Head of IBD Research at Mayo Clinic and Co-chair of the Novel Clinical Trials in Inflammatory Bowel Disease session at DDW, where the Antegren Phase II data were presented. "These Phase II data findings are an important contribution to the continuing development of the drug in the treatment and management of this disease."
SOURCE: Elan Corporation and Biogen Inc. Related Links: Elan Corporation and Biogen Inc.
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