Media Release: Dr. Brian K. Dieckgraefe.

(From MediaNet Press Release Wire)

MEDIA RELEASE PR20491 Sargramostim Therapy Demonstrates Significant Improvements in Quality-of-Life for Patients with Crohn's Disease HONOLULU, Oct. 31 /PRNewswire-AsiaNet/ -- - Study Results Presented at American College of Gastroenterology Annual Meeting - Sargramostim therapy was associated with improved and maintained quality-of-life (QOL) in patients with moderately to severely active Crohn's disease, according to data presented at the 70th annual American College of Gastroenterology (ACG) Meeting. These data from N.O.V.E.L. 1, a multi-center, randomized, double-blind, placebo-controlled Phase 2 trial, demonstrated treatment with sargramostim resulted in significant improvements in quality-of-life from baseline to Day 57 versus placebo, as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) and the Short Form 36 (SF-36) health surveys. Improvements in QOL ranging from moderate to large occurred early and were maintained throughout the treatment. "Crohn's disease severely impacts both physical and emotional quality-of- life, and current treatments are often as debilitating as the disease itself," said Brian K. Dieckgraefe, M,D., Ph.D., co-investigator and assistant professor of medicine, Division of Gastroenterology, Washington University School of Medicine, St. Louis. "This study demonstrates that sargramostim offers significant benefits to Crohn's disease patients in terms of improving patient-reported outcomes and facilitating a more active and productive quality-of-life." Evolving research suggests a primary defect in Crohn's disease may arise from a breakdown in intestinal barrier function composed of several layers of cells that protect the gastrointestinal (GI) tract. This breakdown may precede secondary inflammatory processes associated with Crohn's disease. Sargramostim may address a primary defect of Crohn's disease by helping to improve immune cell function within the intestinal barrier, unlike other therapies that broadly suppress immune response and inflammatory symptoms. In the United States, sargramostim is marketed as LEUKINE(R) by Berlex, Inc., a U.S. affiliate of Schering AG, Germany. About the Study This study was a randomized, placebo-controlled Phase 2 trial evaluating the efficacy and safety of sargramostim 6 g/kg/day for 8 weeks in patients (N=124) with moderately to severely active Crohn's disease. The IBDQ, the standard instrument for assessment of health-related quality-of-life (HRQOL) in patients with inflammatory bowel diseases, and the SF-36, a multi-purpose, short-form health survey that is often used as a generic instrument, were used to measure physical, emotional and social outcomes from the patients' ...