Cell Therapeutics, Inc. (CTI) Launches Phase III Study for Pixantrone in Relapsed Indolent Non-Hodgkin's Lymp...( Fast Track-Designated Study Approved...),Health

Fast Track-Designated Study Approved Under FDA Special Protocol Assessment

Process Could Expand Indication to Indolent NHL

SEATTLE, Sept. 12 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTAX) today 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<0.001) in relapsed indolent NHL patients," said James A. Bianco, M.D., President and CEO of CTI. "That data, coupled with the marked increase in PFS when pixantrone was added to a fludarabine-based regimen, provides a strong rationale for proceeding with thi
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