Trubion Announces Initiation of Phase 2b Study of TRU-015 for the Treatment of Rheumatoid...( Study to Evaluate Preferr...),Health

Study to Evaluate Preferred Induction Dosing Regimen

SEATTLE, May 7 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals Inc. (Nasdaq: TRBN) today announced that its partner, Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), has commenced patient dosing in the next Phase 2b clinical trial of TRU-015 in patients with rheumatoid arthritis (RA). In collaboration with Trubion, Wyeth Pharmaceuticals is developing TRU-015, SBI-087 and other CD20-directed products.

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 be 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.

"Data reported previously demonstrates TRU-015's ability to significantly improve RA signs and symptoms, and maintain response rates with repeat administration of single doses given every six months," said Peter Thompson, M.D., FACP, president, CEO and chairman of Trubion. "This study is designed to help us identify an induction, or initial, dosing regimen and allow us to further establish the most effective treatment regimen for TRU-015. We believe this study has been designed in a way that could support a registration package, and we look forward to the results of
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