CELL THERAPEUTICS RELEASES INTERIM DATA FROM NHL STUDY

Cell Therapeutics has announced that, based on preliminary confirmed and unconfirmed complete response rates observed among the first 40 patients with aggressive non-Hodgkin's lymphoma (NHL) treated in its randomized Phase III trial of pixantrone, the company's data monitoring committee recommended that the study continue. The company plans to conduct a second interim analysis early next year.

The trial is a for patients with relapsed, aggressive non-Hodgkin's lymphoma who have received two or more prior therapies. The trial is being conducted in 130 sites in 17 countries. Patients are randomized to receive either pixantrone or another single-agent drug of physician's choice currently used for the treatment of this patient population.

The trial is designed to examine the complete response or unconfirmed complete response rate, time to tumor progression and overall survival. The study was powered based on a complete response rate assumption of less than 5 percent for the control arm and a 10 percent improvement in CR rate for the pixantrone arm. The study is being conducted under a Special Protocol Assessment from the FDA, and pixantrone has received fast-track designation for this indication.