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Trubion Pharmaceuticals Announces Presentation of Positive TRU-015 and SBI-087 Data at the 2008 Annual European Congress of Rheumatology Meeting
Date:6/16/2008

at the time of this assessment. 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. B-cell depletion and recovery following re-treatment with TRU-015 was comparable to that seen after initial treatment. Ongoing patient evaluations showed maintenance of ACR responses following administration of a single dose of TRU-015 at six-month intervals.

Trubion announced in May that Wyeth had commenced patient dosing in the next Phase 2b clinical trial of TRU-015 in patients with RA. The randomized, parallel, double-blind, placebo-controlled, dose-regimen-finding study will evaluate the safety and efficacy of two dosing regimens. Treatment will be administered to approximately 216 patients with active, seropositive RA on a background of methotrexate. The primary outcome measurement for the TRU-015 Phase 2b study will be the ACR 50 response measured at 24 weeks. Secondary outcome measurements will be ACR 20 and Disease Activity Score-28 responses.

SBI-087 Demonstrates Favorable in Vivo B-Cell Depletion and Pharmacokinetic Profiles (THU0171)

SBI-087 is a humanized SMIP drug candidate that is directed against the CD20 antigen. The objective of the preclinical study conducted by Wyeth was to evaluate the pharmacokinetics and pharmacodynamics of SBI-087 following a single intravenous dose. Administration of SBI-087 resulted in dose-dependent B-lymphocyte depletion in peripheral blood and lymphoid tissues that was more profound and sustained in SBI-087-treated groups compared with rituximab.

In April, Trubion announced that Wyeth initiated a Phase 1 SBI-087 dose escalation clinical trial that is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of SBI-087 in patients with RA. This Phase I trial is designed to enroll patients who meet the criteria for RA with Functional Class I, II or III, and
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SOURCE Trubion Pharmaceuticals Inc.
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