Trubion Announces Initiation of Phase I/II Clinical Trial of TRU-015 for the Treatment of B-Cell Non-Hodgkin'...( SEATTLE Dec. 10 /- Trubion Pharma...),Health

SEATTLE, Dec. 10 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN), today announced that Wyeth Pharmaceuticals has initiated a Phase I/II clinical trial of TRU-015, Trubion's lead Small Modular ImmunoPharmaceutical (SMIP(TM)) drug candidate, for the treatment of non-Hodgkin's lymphoma (NHL). The nonrandomized, open label, uncontrolled, single-group assignment clinical trial is designed to evaluate the safety and efficacy of TRU-015 in subjects with NHL. Trubion is co-developing TRU-015 and other CD20-directed therapies with Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE).

"We believe that TRU-015 may be a valuable tool in the treatment of NHL, and we are looking forward to working with Wyeth as this development program moves forward," said Peter Thompson, M.D., FACP, president, chief executive officer and chairman of Trubion.

TRU-015 Phase I/II Clinical Trial Protocol

The Phase I/II clinical trial is expected to enroll approximately 120 NHL subjects who have undergone two or more prior therapies and have relapsed or refractory disease. Efficacy will be evaluated according to disease response and progression status per the International Response Criteria for NHL. Participants will receive an escalating dose of four weekly infusions of TRU-015. Once a maximum tolerated dose is confirmed, or once a maximum dose to be studied is determined to be safe and well tolerated, an expanded cohort of subjects with relapsed follicular NHL will be evaluated for efficacy.

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