Embargoed for Release Until: Sunday, November 2, 1997, 6:00 p.m. Contact: Marie Kendra Tehonica (202) 973-1361 [email protected]

Gene-Based Therapy Offers Potential Breakthrough in Treating Inflammatory Bowel Disease

November 2, 1997, Chicago, IL -- Unlocking some of the mysteries of genetic materials offers some promising early results in a new treatment approach to Crohn's disease. Crohn's disease and ulcerative colitis are two types of inflammatory bowel disease, a chronic, debilitating and largely incurable inflammation of the intestines that affects over 2 million people in the United States.

Dr. Daniel Present and his colleagues recently reported at the Annual Meeting of the American College of Gastroenterology on a multicenter study of 94 patients who were experiencing fistulae, infected abscesses which form channels to other parts of the bowel or other organs. This is one of the most common manifestations of active Crohn's disease. The theory underlying the treatment is that the chronic intestinal inflammation in Crohn's disease may be related to an imbalance between pro-inflammatory and anti-inflammatory genetic materials affecting the linings of the intestine.

Dr. Present's research has examined the tumor necrosis factor (TNF), which is a pro-inflammatory genetic material. If the pro-inflammatory factors can be subdued or the anti-inflammatory factors strengthened, theoretically, the disease process could be eliminated or improved. A monoclonal antibody, derived from the modified genetic material of laboratory mice, was isolated to operate as an "anti-TNF" agent.

Patients received three treatments over six weeks. All other medications were continued unchanged. Within 14 weeks, 62% of the patients experienced at least 50% reduction in their fistulae, compared to 26% fistulae reduction in patients who did not receive the "anti-TNF" monoclonal antibody treatment. Forty-six percent of the patients treated had their fistulae close completely, compared to 13% of the untreated patients.

While the initial study will require replication in larger patient groups, Dr. Present and his colleagues believe this gene-based therapy approach may well represent a critical breakthrough in treatment of inflammatory bowel disease.

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The ACG was formed in 1932 to advance the scientific study and medical treatment of disorders of the gastrointestinal tract. The College promotes the highest standards in medical education and is guided by its commitment to meeting the needs of clinical gastroenterology practitioners.

Consumers can get more information on GI diseases through the following ACG-sponsored programs:

* 1-800-978-7666 (free brochures on common GI disorders, including ulcers, colon cancer, gallstones and liver disease)

* 1-800-HRT-BURN (free brochure and video on heartburn and GERD)

* www.acg.gi.org (ACG's web site)