Trubion Announces Preliminary Analysis of Phase IIb Results With TRU-015 in Rheumatoid... ( Results Show Improvements in RA Si...)

Trubion Announces Preliminary Analysis of Phase IIb Results With TRU-015 in Rheumatoid Arthritis

Date:9/10/2007

Results Show Improvements in RA Signs and Symptoms Compared to Placebo

SEATTLE, Sept. 10 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals Inc. (Nasdaq: TRBN) today announced preliminary analysis of results from a Phase IIb randomized, double-blind, placebo-controlled, multicenter clinical trial of its TRU-015 product candidate for rheumatoid arthritis (RA). The results indicated that Trubion's TRU-015 product candidate, at well-tolerated dosages, provided statistically significant improvements in RA signs and symptoms compared to placebo at 24 weeks. Trubion is co-developing TRU-015 with Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), for the treatment of rheumatoid arthritis.

TRU-015 Phase IIb Clinical Trial Protocol and Results

The Phase IIb randomized, double-blind, placebo-controlled, multicenter clinical trial included 276 patients with rheumatoid arthritis who were also receiving methotrexate as background therapy. Patients in the Phase IIb study were randomized evenly into five groups that received either placebo, 200 mg, 400 mg, 800 mg or 1600 mg of TRU-015.

The study was designed to evaluate the safety and efficacy of a single intravenous infusion of TRU-015 compared to placebo for a 24-week period, with a primary endpoint of improvement on the Disease Activity Score (DAS)-28 scale at 12 weeks, and secondary endpoints including response rates at 24 weeks using American College of Rheumatology (ACR) criteria.

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Trubion Announces Preliminary Analysis of Phase IIb Results With TRU-015 in Rheumatoid...( Results Show Improvements in RA Si...),Health