Trubion Pharmaceuticals Inc. (TRBN)

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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
Thursday March 27, 4:00 pm ET
First Patient Dosed in Phase 1/2 Trial of TRU-016, Trubion's Proprietary Product Candidate
SBI-087 for RA Expands Trubion's Family of Customized, Differentiated Product Candidates

SEATTLE, March 27 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN - News) today announced that it has initiated a Phase 1/2 clinical trial of TRU-016, the company's lead proprietary Small Modular ImmunoPharmaceutical (SMIP(TM)) drug candidate, for the treatment of chronic lymphocytic leukemia (CLL). The company also announced a new, next-generation product candidate for clinical evaluation and provided an update on its product pipeline.

TRU-016 for CLL and NHL

Trubion today announced that patient dosing has commenced in its Phase 1/2 clinical trial of TRU-016 for CLL. The open label clinical trial is composed of two parts: a Phase 1 dose escalation study designed to evaluate the safety, tolerability and pharmacokinetics of TRU-016; and a Phase 2 expansion cohort designed to further evaluate safety and to estimate clinical activity of TRU- 016 in patients with previously treated CLL or small lymphocytic leukemia. Trubion currently retains all development and commercialization rights for the TRU-016 program.

This Phase 1/2 clinical trial is designed to enroll patients who have undergone at least one prior therapy and have relapsed CLL or small lymphocytic leukemia. Efficacy will be evaluated according to disease response and progression status per the International Response Criteria for CLL. Participants will receive intravenous administration of TRU-016 over a four- week period.

"This is an important milestone for our proprietary program and we look forward to the results of TRU-016's ongoing clinical evaluation," said Peter Thompson, M.D., FACP, president, CEO and chairman of Trubion. "Our proprietary product candidate, TRU-016, has demonstrated potent anti-tumor activity in pre-clinical evaluation and may provide patients with improved therapeutic options or benefits when used alone or in conjunction with chemotherapy or CD20-targeted immunopharmaceuticals."

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