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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

owing administration of a single dose of TRU-015 at six-month intervals along with B-cell depletion and recovery following re-treatment, comparable to results seen after initial treatment.

Results from the Phase 1/2a re-treatment study also indicated total serum IgG levels were relatively preserved. In addition, subjects treated with three or more courses of therapy experienced persistent decreases in rheumatoid factor and IgM levels. Re-treatment with TRU-015 did not result in an increase in any adverse events compared with the initial infusion, and the re-treatment infusions were well-tolerated. No neutralizing antibodies to TRU-015 had been detected at the time of this assessment.

TRU-015 Phase 2b Re-treatment Data

A separate Phase 2b study (15002) is also ongoing. The initial treatment results were presented last year. Re-treatment data from study 15002 were not available in time to present at ACR but will be submitted for presentation in a future peer-reviewed forum. The objective of the two ongoing re-treatment studies is to evaluate the safety; tolerability; pharmacodynamics (PD), specifically, B-cell depletion over time; pharmacokinetics; and immunogenicity of repeat doses of TRU-015 for RA following initial administration.

Two hundred and forty patients entered the open-label re-treatment portion of the Phase 2b study (15002) and received 800 mg of TRU-015. Data was available for all 240 patients at the time of this evaluation, of which 204 patients were rheumatoid factor (RF) positive. Under the study protocol, the efficacy endpoint was based on all randomized RF-positive subjects who received any portion of study drug.

Based on the initial treatment results from studies 15001 and 15002, the selected dose for re-treatment in 15002 and additional studies is 800 mg. Preliminary analyses demonstrate that at 24 weeks, ACR 20, 50 and 70 response rates for patients in the initial 800 mg dose group (n=43) who were subsequently r
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SOURCE Trubion Pharmaceuticals Inc.
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