( are performedin the U.S. and Europe e...)PDL BioPharma Announces Long-Term Nuvion Data Presented at 2007,Digestive Disease Week,Health

are performed in the U.S. and Europe every year. In April, after review of the current data from an external data monitoring committee, PDL announced 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.

Summary of Results (Abstract T1279)

In the study presented by Dr. Sandborn, 138 subjects with IVSR-UC were treated with visilizumab at 5, 7.5, 10, 12.5 or 15 mg/kg intravenously on two consecutive days (Days 1 and 2). Eighty-nine (64.5%) of the 138 patients demonstrated a clinical response at day 30. Clinical response was defined by using one of two standard measures to determine the severity of the patient's ulcerative colitis.

Patients were followed for a median of 356 days, ranging from 21 to 792. During the follow-up period, 53% (73/138) received medical or surgical rescue therapy. Only 28 (35%) of the Day 30 responders ended up undergoing rescue therapy during subsequent observation. Encouraging new data presented at DDW from this study show the median time to first rescue therapy was 310 days. Forty-six (33%) patients underwent colectomy (colon removal), either as first rescue therapy or subsequent to failed medical rescue.

The Nuvion antibody was adequately tolerated, with 120 (87%) patients experiencing transient, mild to moderate infusion reactions due to cytokine release within the first three days of treatment. These symptoms were minimized with pre-medication and hydration. A total of 17 (12%) patients also experienced serious or opportunistic infections, including localized mucocutaneous herpes and candida infections, but there were no disseminated opportunistic infections. The Nuvion antibody also produced a transient decline in T cells, which generally lasted less than 30 days.

Additional Nuvion Data Presentations

Two additional presentations at DDW support the potential of Nuvion as a tre
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