Cell Therapeutics completes enrollment in Phase III lymphoma trial

An analysis of the data is expected in the second half of 2008. Based on prior discussions with the FDA the data could provide a registration path for pixantrone if final study results are adequate for submitting a new drug application with the FDA in early 2009 with a potential approval in 2009. A total of 140 patients were enrolled in the study, 97 patients are currently evaluable according to histological intent to treat, or HITT, criteria and will be included in the final analysis of the study.

The Extend clinical trial is a phase III single agent trial of pixantrone for patients with relapsed, aggressive non-Hodgkin’s lymphoma who received two or more prior therapies and who were sensitive to treatment with anthracyclines. The trial was designed to examine the complete response or unconfirmed complete response rate, time to tumor progression, and overall survival. The study was conducted under a special protocol assessment from the FDA and pixantrone has received fast track designation for this indication.

Jack Singer, chief medical officer at CTI, said: “PIX301 (Extend) examines the effectiveness of pixantrone in patients with relapsed and refractory diffuse large B cell lymphoma, a population where current therapies seldom induce complete remissions. Based on a blinded current independent assessment of events in the trial we believe we have an adequate sample size of eligible patients to meet the primary objective of the trial.”