BioCentury
ARTICLE | Clinical News

PF-05280586: Phase I/II started

May 14, 2012 7:00 AM UTC

In March, Pfizer began the double-blind, international Phase I/II REFLECTIONS B328-01 trial to compare PF-05280586 vs. Rituxan/ MabThera rituximab in 210 patients who had an inadequate response to tumor necrosis factor (TNF) therapy. Patients will continue methotrexate throughout the study and will receive 1,000 mg IV PF-05280586, Rituxan or MabThera given on days 1 and 15. Pfizer told BioCentury that the trial is expected to finish in December 2013. Pfizer plans to conduct an additional efficacy study of PF-05280586 in RA, and expects to also study the candidate in >=1 cancer indications. Pfizer said it plans to seek marketing approval of PF-05280586 in Europe and the U.S.

Biogen Idec Inc. (NASDAQ:BIIB, Weston, Mass) and the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY, Basel, Switzerland) co-market Rituxan in the U.S., while Roche markets it as MabThera elsewhere. In Japan, rituximab is co-marketed as Rituxan by Chugai Pharmaceutical Co. Ltd. (Tokyo:4519, Tokyo, Japan), which is majority owned by Roche, and Zenyaku Kogyo Co. Ltd. (Tokyo, Japan). Rituximab is approved to treat Wegener's granulomatosis and microscopic polyangiitis, non-Hodgkin's lymphoma (NHL), rheumatoid arthritis, diffuse large B cell lymphoma (DLBCL) and chronic lymphocytic leukemia (CLL). ...