University Of Pittsburgh Clinical Study To Test Antibody Therapy For Patients With Severe Ulcerative Colitis
PITTSBURGH, March 27, 2006 — University of Pittsburgh School of Medicine researchers announced today the start of a global clinical trial evaluating an antibody therapy that could potentially delay the need for surgery for patients with severe ulcerative colitis (UC) that no longer responds to standard medical therapies. The University of Pittsburgh School of Medicine was the first institution to enroll a patient into this clinical trial.
Ulcerative colitis is a chronic disease of the colon, or large intestine, and is marked by inflammation and ulceration of the colon mucosa, or innermost lining, which can cause diarrhea, pain and bleeding. In severe cases, individuals may have diarrhea 10 to 20 times a day, which may lead to dehydration, fever, hospitalization and blood transfusions.
Participants in the study, which is sponsored by PDL BioPharma, Inc., will receive visilizumab, a monoclonal antibody that is designed to target and block the action of T cells, the same 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.
“More than one million people worldwide suffer from ulcerative colitis, which primarily affects women and men in their 30s, but can occur at any age,” said Scott E. Plevy, M.D. , an associate professor of medicine in the Division of Gastroenterology, Hepatology and Nutrition at the University of Pittsburgh School of Medicine. “An estimated 25 to 40 percent of these patients eventually fail to respond to oral and intravenous steroids, and their only treatment option is invasive surgery to remove their colon.” Dr. Plevy also is a co-director of the Inflammatory Bowel Disease Center and a member of the department of immunology.
The University of Pittsburgh Medical Center (UPMC) is one of 75 centers worldwide participating in the Phase 2/3 clinical study, which is evaluating the safety and effectiveness of visilizumab for the treatment of intravenous steroid-refractory UC. During the clinical study, patients will receive two intravenous injections of either the study drug or placebo. The second injection will be delivered the day immediately following the first injection. Patients will be assessed for reduction of clinical symptoms by the Mayo Score and healing of their colonic mucosa as determined by lack of ulcerations, bleeding and friability, and monitored at regularly scheduled intervals for up to 36 months.
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 respond to therapy but subsequently experience a worsening of UC symptoms may be eligible to enroll in the visilizumab retreatment study that also has been initiated at the University of Pittsburgh School of Medicine.
“The definitive treatment for ulcerative colitis is colectomy, which has significant consequences including the devastating impact of the surgery on a patient’s quality of life, and post-surgical complications that frequently arise, such as small bowel obstructions, leakage, abscesses and inflammation, ” said Dr. Plevy. “We are studying visilizumab to determine if it may delay or prevent colectomy for some patients with fulminant ulcerative colitis refractory to intravenous steroids.”
The study, called RESTORE 1, is open to individuals who are 18 years and older, have been diagnosed with UC, and have active disease despite corticosteroid therapy. Study medication will be provided to all qualified study participants at no cost. Individuals who fit the criteria and are interested in participating can call 1-800-772-0482 or visit www.RestoreTrial.com.
About the University of Pittsburgh Medical Center
The University of Pittsburgh Medical Center is the largest integrated health care delivery system in Pennsylvania and one of the leading nonprofit medical centers in the country. The 40,000-employee organization is the largest employer in western Pennsylvania. UPMC is consistently ranked among the nation’s top hospitals by U.S. News & World Report, and the University of Pittsburgh and affiliated programs attract more than $375 million annually in National Institutes of Health (NIH) funding, ranking the academic medical center seventh in the nation in 2004.
About PDL BioPharma, Inc.
PDL BioPharma, Inc. (Nasdaq: PDLI), is a biopharmaceutical company focused on the research, development and commercialization of novel therapies for inflammation and autoimmune diseases, acute cardiac conditions and cancer.