Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTAX) announced the launch of its phase III clinical trial, known as PIX303, of pixantrone for patients with indolent non-Hodgkin's lymphoma (NHL) who have relapsed following first-line therapy. The Company has a Special Protocol Assessment (SPA) in place with the U.S. Food and Drug Administration (FDA) for PIX303. The trial will examine progression-free survival (PFS), which is the rate at which a patient's lymphoma recurs or progresses, following treatment with pixantrone, fludarabine, and rituximab (FP-R) compared to treatment with fludarabine and rituximab (F-R), a commonly used second-line regimen in relapsed indolent NHL. The randomized, multi-center, multi-national trial is expected to enroll 300 patients, to be completed over a 12 to 16 month period. Dependant on the rate of progression, an interim analysis is targeted in 2009 and, if successful, could serve as a potential supplemental indication for pixantrone. Pixantrone has received fast track designation from the FDA for this indication.

"We have previously shown in a randomized controlled trial that the addition of pixantrone to rituximab significantly increased median time to progression over rituximab alone (13.0 months versus 8.1 months for rituximab alone; p