Seattle, Washington-based biopharmaceutical company Cell Therapeutics Inc. announced achieving the primary efficacy endpoint for a study of pixantrone in patients with advanced, relapsed aggressive non-Hodgkin's lymphoma based on a preliminary intent to treat efficacy analysis.

The company stated that the study in Phase III, carried out at 130 sites in 17 countries, enrolled 140 patients, who were then randomized to receive either pixantrone or standard chemotherapy.

The study demonstrated that patients treated with pixantrone achieved a high rate of confirmed and unconfirmed complete remissions, compared with patients treated with chemotherapy (14/70 (20.0 percent) for pixantrone arm compared to 4/70 (5.7 percent) for the standard chemotherapy arm (p = 0.02).

Cell Therapeutics also said it expects to begin submission of a rolling New Drug Application to the U.S. Food and Drug Administration in early 2009.

Cell Therapeutics actually market another drug, Zevalin, for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL), including patients with rituximab refractory follicular NHL. Zevalin is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naive, low-grade and follicular NHL based on studies using an endpoint of overall response rate, which is a surrogate for progression free survival.