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Trubion Initiates Phase 1/2 Study of TRU-016 in CLL, Announces Next-Generation Product Candidate for RA and Provides Product Pipeline Update
Date:3/27/2008

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TRU-015 for RA

In addition to SBI-087, Trubion also announced today the protocol details and design of the next Phase 2b study of TRU-015 for patients with RA that Trubion believes could be supportive of a registration package. The randomized, parallel, double-blind, placebo-controlled, dose regimen-finding study will evaluate the safety and efficacy of two dosing regimens 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 include the American College of Rheumatology (ACR) 50 response measured at 24 weeks. Secondary outcome measurements will be ACR 20 and 70 and DAS-28 responses. This study is currently preparing for participant recruitment.

"SBI-087 strengthens our product pipeline and leverages the combined clinical experience of our strategic collaboration with Wyeth," added Dr. Thompson. "We believe that SBI-087 and TRU-015 together will play an important role in improving patient care and helping us establish category leadership in autoimmune and inflammatory diseases."

TRU-015 and SBI-087 for SLE

Wyeth intends to pursue clinical evaluation of SBI-087 in Systemic Lupus Erythematosus (SLE) and an investigational new drug filing is expected by the end of the year. As a result, Wyeth no longer intends to evaluate TRU-015 in a planned Phase 1 study originally designed to determine how the body absorbs and chemically changes a single infusion of TRU-015 in subjects with kidney disease caused by lupus. No patients were enrolled in the planned TRU-015 Phase 1 study.

TRU-015 for NHL

Trubion also announced today that Wyeth, in reviewing the competitive landscape for CD20-directed therapies, has determined not to pursue such therapies for oncology indications and, as a result, has discontinued clinical development of TRU-015 for non-Hodgkin's lymphoma.

In addition to TRU-015 and SBI-0
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SOURCE Trubion Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
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