Irritable Bowel Syndrome Message Boards | Pipeline Treatments, Novel Procedures Offer New Options for GI Diseases

CONTACT: Tuesday, May 18, 3:00 pm CDT Kellie Hanzak, 202-955-6222 khanzak@spectrumscience.com Jessica Willocks, 301-941-2625 jwillocks@gastro.org

In New Orleans: Morial Convention Center 504-670-6420

RESEARCH HONES IN ON THERAPIES AND DIAGNOSIS OF BOWEL DISEASES

Pipeline Treatments, Novel Procedures Offer New Options for GI Diseases

New Orleans, LA � Inflammatory bowel diseases collectively cause significant lifestyle sacrifices and suffering and millions of dollars in related health care costs every year, partially due to a lack of effective diagnostic procedures and therapies. In new studies presented today at Digestive Disease Week in New Orleans, researchers show evidence of accurate and effective new methods for diagnosis, as well as improved treatment options, for sufferers of ulcerative colitis and Crohn's diseases.

Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

"We are pleased to see more attention directed toward improving the lives of people suffering from inflammatory bowel diseases," said Jim Lewis, M.D., of the University of Pennsylvania. "For too long, the rate of discovery was slow. Now we are seeing more answers for the millions of sufferers."

Capsule Endoscopy in IBD: Findings and Effects on Clinical Outcomes (Abstract 105669*)

The M2A video capsule or "camera pill" allows gastroenterologists their best view yet of the small bowel, assisting in the diagnosis of inflammatory bowel disease. Until now, studies have not analyzed the influence of capsule endoscopy on clinical decision-making and therapeutic outcomes in IBD.

According to research presented by scientists from Mount Sinai Medical Center, use of the video capsule improves clinical outcomes significantly.

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For the study, the team of researchers reviewed the results of capsule endoscopy in patients with IBD-related indications. A total of 65 patients met the inclusion criteria and fit in four categories: A) abnormal small bowel series, rule out Crohn's Disease (CD); B) abdominal pain, normal radiologic studies, rule out CD; C) known ulcerative or Crohn's colitis; normal small bowel series and persistent symptoms, rule out small bowel disease; and D) known CD, with persistent obscure bleeding.

Overall, for 20 of the 21 patients (95 percent) in whom major diagnostic findings were discovered using capsule endoscopy, therapeutic decisions based on the results led to clinical improvement in patient outcome. In groups A and B, an absence of small bowel findings in 30 of 32 patients helped rule out CD. Throughout an average follow-up of 19 months, no evidence of CD developed, leading to a negative predictive value for the capsule study of 100 percent in this setting. In groups C and D, researchers discovered positive diagnostic findings on capsule endoscopy in 18 of 33 patients.

"Based on our research, we believe that capsule endoscopy may play an important role in clinical diagnosis and therapeutic decisions in patients with IBD indications," said Peter Legnani, M.D., lead author of the study. "We hope that the ease of use of the capsule may encourage more patients to undergo screening to confirm diagnosis of IBD and receive appropriate treatment."

Basiliximab (anti-CD25) for the Treatment of Steroid Resistant Ulcerative Colitis (Abstract 104640*)

Steroid therapy is one of the most effective treatments for ulcerative colitis (UC), which causes inflammation and ulcers in the lining of the large intestine, but up to 30 percent of patients will have a poor response to steroids. These steroid-resistant individuals present a difficult clinical challenge to gastroenterologists, because few treatment options exist after steroids other than removal of the entire colon (colectomy).

Basiliximab (Simulect�), a novel monoclonal antibody, has potential as a new treatment option, according to research from Henry Wellcome Laboratories at the University of Bristol in England.

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Basiliximab has been proven effective as a steroid sensitizer in steroid resistant UC both in the lab and in humans. This uncontrolled pilot study examined an extended series of 30 steroid resistant UC patients treated with basiliximab. Twenty patients with moderately active disease and 10 patients with severe disease were treated with a single intravenous (IV) dose of basiliximab (40 mg) in addition to their standard steroid therapy to monitor for remission within eight weeks, defined by an Ulcerative Colitis Symptom Score (UCSS) of less than two.

A total of 24 out of the 30 patients (80%) improved their UCSS score, with 19 of 30 (63%) achieving full remission. In the moderate disease group, 14 of 20 patients (70%) achieved full remission, and an additional five of 20 (25%) showed an improvement. In the severe disease group, five of the 10 patients (50%) achieved remission, while five required colectomy. There were no infusion reactions.

"These studies show that the use of basiliximab can provide significant improvements or remission for patients with ulcerative colitis," said Tom Creed, M.D., lead author of the study. "We hope that a larger, controlled trial will confirm these results and help make this potentially valuable therapy available to patients who can benefit from it."

Randomized, Double-Blind, Placebo Controlled, Parallel Arm, Safety and Efficacy Trial of Once-Daily, Oral OPC-6535 in the Treatment of Active Ulcerative Colitis (Abstract 105516*)

For patients suffering from severe ulcerative colitis (UC), new treatments that are safe and have minimal side effects are desperately needed. In this randomized study, researchers at the University of Chicago examined the effectiveness and tolerability of the compound OPC-6535 to treat UC. OPC-6535 was administered orally in a once-daily 25 mg or 50 mg dose to subjects with a new or established diagnosis of UC, flare within 12 weeks, and Disease Activity Index (DAI) of four to 11 on a scale of 12. A total of 186 patients were given either OPC-6535 or placebo for eight weeks. Patients were permitted to take 5-ASA (aminosalicylic acid) if they were stable for 14 days before entry and subsequent study duration (approximately 75% of subjects); 5-ASA is a standard treatment for UC.

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ore than half (55%) of the 25 mg group and 48 percent of the 50 mg group showed clinical improvement. The average change in DAI was significantly greater in the 25 mg group and was nearly statistically significant in the 50 mg OPC-6535 group versus placebo. Improvement in physician global assessment was more noticeable in the 50 mg dosage group, as a significantly higher proportion of these patients achieved remission (DAI 0-1) compared to the other treatment groups.

Responses were uniformly greater in the subgroup of patients with more severe disease. No differences were observed between 5-ASA users and non-users. "Based on these results, we are confident that OPC-6535 could be an effective treatment option for patients with ulcerative colitis, particularly in those with moderately severe disease," said Stephen Hanauer, M.D., lead author of the study.

"Further clinical studies are needed to confirm the best dose, but we were pleased to see a positive response to higher doses, as the efficacy may be even greater." ### Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 15-20, 2004 in New Orleans, Louisiana. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. *Abstract numbers listed above correlate to abstract ID numbers listed on the DDW Web site, www.ddw.org. They do not coincide with program numbers as found in the printed DDW Program Guide.

http://www.ddw.org/media/newsReleases/IBDTherapies.pdf

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Heather is the Administrator of the IBS Message Boards. She is the author of Eating for IBS and The First Year: IBS, and the CEO of Heather's Tummy Care. Join her IBS Newsletter. Meet Heather on Facebook!

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