MEDIA CONTACT: Elizabeth Crown at 312-503-8928 or e-crown@northwestern.edu

August 17, 2004

Research Targets Ulcerative Colitis

CHICAGO --- Northwestern University Feinberg School of Medicine is conducting a clinical study to evaluate the effectiveness of a new treatment – an antibody product -- for ulcerative colitis.  The study medication, called visilizumab, is the first antibody therapy that blocks the process that leads to inflammation of the colon.

Northwestern is one of only eight centers in the nation participating in the study, which will determine if visilizumab therapy may be an effective alternative to surgery to remove a diseased colon.

The principal investigator on the study is Alan Buchman, M.D., associate professor of medicine at the Feinberg School, director of the Inflammatory Bowel Disease Center at Northwestern and a staff physician at Northwestern Memorial Hospital.

Ulcerative colitis is an inflammatory bowel disease that causes inflammation and ulceration of the mucous membrane that lines the colon and the rectum. The most common symptoms of ulcerative colitis are abdominal pain, rectal bleeding and diarrhea. In severe cases, patients with ulcerative colitis may have diarrhea 10 to 20 times a day. 

Individuals with severe ulcerative colitis may become dehydrated and may require hospitalization and a blood transfusion.

About 400,000 people in the United States have ulcerative colitis. Of these, about 20 percent have such a severe case that oral and intravenous steroid treatments fail and the only option left is invasive surgery to remove all or part of the colon.

Patients with ulcerative colitis have problems with infection-fighting white blood cells called T-cells in the lining of the colon. In many cases of ulcerative colitis, the T-cells may overreact to normal bacteria or proteins in the diet and cause inflammation of the colon.  Over time, this can lead to severe intestinal damage, including ulcers. 

The new therapy – a laboratory-made antibody – binds to and selectively attacks the problematic T cells, preventing them from producing cytokines, chemicals that cause inflammation and can damage the colon. 

“What makes visilizumab different from other biological therapies is that rather than combating a specific pro-inflammatory cytokine, this medication targets a particular blood cell that produces the cytokine,” Buchman said.

Evidence from a small, earlier study showed visilizumab may assist the body in healing itself from the damage inflicted by chronic inflammation.  The first human clinical study with visilizumab -- in those with severe ulcerative colitis and who otherwise were facing surgery -- showed that the majority of participants were relapse-free for up to 12 months. 

Visilizumab may represent a large shift in how severe UC may be treated, Buchman said. 

“It gives us another medical option before resorting to surgically removing the colon, which can be a very devastating surgery for patients,” Buchman said.

The Northwestern research study is open to participants who are 18 to 70, have been diagnosed with ulcerative colitis and who have active disease despite receiving corticosteroid therapy.  The study medication will be provided to qualified participants at no cost.   For information call Northwestern Memorial Hospital’s physician referral department at 312-926-8400.