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Visilizumab is a novel humanized monoclonal antibody that binds to CD3, a protein found on the outer membrane of T cells. T cells are white blood cells that play a role in inflammatory and immune-mediated processes in the body, including diseases such as Inflammatory Bowel Disease (IBD). Visilizumab is currently being tested in a global Phase 2/3 clinical program, (RESTORE Trial) www.restoretrial.com in patients with intravenous steroid-resistant ulcerative colitis (IVSR-UC) and Phase 2 studies in patients with Crohn’s disease (CD). PDL announced in April 2007 that it would advance the Nuvion antibody into a second pivotal study in patients with IVSR-UC, the most severe form of this inflammatory bowel disease that attacks the colon. PDL BioPharma holds all worldwide rights to the development, manufacturing and sales of visilizumab.
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About Inflammatory Bowel Disease
Approximately two million people suffer from inflammatory bowel disease (IBD) in the United States and Western Europe. IBD consists of two major subtypes: ulcerative colitis (UC); which is characterized by inflammation and ulceration of the epithelial lining of the rectum and large intestine, and Crohn's disease (CD), which is characterized by inflammation and ulceration of the small intestine and the beginning of the large intestine. Current treatments for both diseases include the use of immunomodulators such as corticosteroids, azathioprine and/or cyclosporine, and 5-amino-salicylates. Despite the availability of these drugs, there is a need for effective therapies to treat severe IBD and improve long-term patient outcomes, as almost one-third of UC patients and more than two-thirds of CD patients may need surgery to control their disease.