July 20, 2006

Vanderbilt studying new drug to treat severe ulcerative colitis Recruiting patients for clinical trial

People who suffer from severe ulcerative colitis may find relief from a new drug that is being tested at Vanderbilt University Medical Center.

People who suffer from severe ulcerative colitis may find relief from a new drug that is being tested at Vanderbilt University Medical Center.

Researchers here are seeking people with severe ulcerative colitis (UC) to participate in a phase 2/3 study of an investigational antibody therapy that could potentially prevent or delay the need for surgery in patients with the condition who no longer respond to standard medical therapies.

Vanderbilt is one of 18 sites in the United States conducting the international clinical trial, and the only site in Tennessee.

“Ulcerative colitis is a chronic disease caused by an abnormality in the body’s immune system that leads to inflammation and ulceration of the innermost lining of the colon (or large intestine), which can cause diarrhea, pain and bleeding,” explained David Schwartz, M.D., director of the Inflammatory Bowel Disease Center at Vanderbilt.

In severe cases, individuals may have diarrhea 10 to 20 times a day, which can lead to dehydration, fever, hospitalization and the need for blood transfusions. An estimated 25 percent to 40 percent of these patients eventually fail to respond to standard medical therapies of oral and intravenous steroids.

Patients who participate in the trial will receive two intravenous injections of either visilizumab or a placebo.

The investigational treatment, visilizumab, also known as Nuvion, is a monoclonal antibody. Visilizumab is designed to target and block the action of T-cells, the cells believed to cause UC, with the aim of significantly reducing the symptoms of UC and potentially delaying the need for colectomy, or surgical removal of the colon.

Schwartz said that, while removing the colon is the definitive treatment for patients with severe UC, it can be associated with complications such as small bowel obstructions, leakage, abscesses and inflammation, or pouchitis.

“We are studying visilizumab to determine if it can offer patients a new therapeutic alternative by delaying the need for colectomy,” Schwartz said. “The study is really an acute treatment study. These are folks who would otherwise likely need to have their colon removed. This is a medicine that works quickly to get them well and prevent that from happening.

“That being said, the patients are followed for three years to monitor the longterm effects of the medicine. There is some evidence that folks who receive this medicine may stay well for a long time. It sort of resets the immune system for awhile.”

Steve Wallace, executive director of the Tennessee Chapter of the Crohn’s & Colitis Foundation of America, said more than 10,000 children and adults in Middle Tennessee live with Crohn’s disease or ulcerative colitis, collectively known as Inflammatory Bowel Disease (IBD).

“More than 1.4 million Americans suffer with these diseases, and another 30,000 new cases are diagnosed every year,” Wallace said. “Children as young as two are being diagnosed each day with colitis, and it is not uncommon for older adults to develop colitis as well.”

“The ongoing IBD research and IBD patient care management provided by Vanderbilt offers great hope to thousands of Tennesseans, and for that, the Crohn’s & Colitis Foundation of America is extremely grateful,” Wallace added.

In an earlier clinical study, the most common adverse events observed in patients treated with visilizumab were transient fever, chills, headache, nausea, vomiting, fatigue and body aches on the days of drug administration.

Patients who receive the study drug visilizumab should see results within a week, Schwartz said.

The study, which is sponsored by PDL BioPharma Inc., is open to individuals 18 and older, who have been diagnosed with UC, and who have active disease despite corticosteroid therapy. Study medication will be provided to all qualified study participants at no cost. For more information, call the clinical study coordinator at 936-1745.

Media For More Information:
Jerry Jones
615-322-4747