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Trubion Reports Re-treatment Results Following Phase 1/2a and Phase 2b Studies Evaluating TRU-015 for Rheumatoid Arthritis
Date:10/27/2008

SEATTLE, Oct. 27 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals Inc. (Nasdaq: TRBN) today announced positive data from a Phase 1/2a study demonstrating that repeat administration with TRU-015 continues to produce persistent responses and significant improvements in rheumatoid arthritis (RA) signs and symptoms based on American College of Rheumatology (ACR) criteria. Trubion also announced positive results following preliminary analyses from a Phase 2b study in which patients have received one course of re-treatment with 800 mg of TRU-015. TRU-015 is being developed by Wyeth Pharmaceuticals in collaboration with Trubion.

TRU-015 Phase 1/2a Re-treatment Data: Re-treatment Administered Every 24 Weeks for 2 Years Produces Well-Tolerated and Consistent Results

Re-treatment data from the Phase 1/2a study (15001) were presented on Oct. 26, 2008, in a poster session at the ACR 2008 Annual Meeting in San Francisco. Patients treated with a single course of TRU-015 at 5 mg/kg or higher in a previously conducted Phase 1/2a study (15001) were eligible for re-treatment. Patients given an initial dose of 5 mg/kg received a single infusion of 5 mg/kg upon re-treatment and those given higher doses of TRU-015 received a single infusion of 15 mg/kg upon re-treatment. Patients were eligible for repeat therapy at 24-week intervals.

Thirty-eight patients entered the Phase 1/2a re-treatment study; some patients have received as many as seven courses of TRU-015 at the time of this assessment. At 24 weeks, ACR 20, 50 and 70 response rates for 18 patients that have received their third re-treatment with 5 mg/kg or 15 mg/kg TRU-015 were 50%, 17% and 11%, respectively. Ongoing patient evaluations demonstrated maintenance of ACR responses foll
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SOURCE Trubion Pharmaceuticals Inc.
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