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news.Trubion Pharmaceuticals has announced that Wyeth Pharmaceuticals has initiated a non-randomized, open-label, uncontrolled, single-group assignment Phase I/II clinical trial of TRU-015, a small modular immunopharmaceutical drug candidate, for the treatment of non-Hodgkin's lymphoma.
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The trial is designed to evaluate the safety and efficacy of TRU-015 in subjects with non-Hodgkin’s lymphoma (NHL). The 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.
Peter Thompson, president, CEO and chairman of Trubion, said: “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.”