CTI closes data set for endpoint analysis in Phase III lymphoma trial

The primary endpoint for the study is the complete remission (CR) and unconfirmed complete remission (uCR) rate in patients receiving either pixantrone or another single agent chemotherapeutic drug. CTI plans to report top-line results in November 2008.

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 conducted at 130 sites in 17 countries. Patients were randomized to receive either pixantrone or another single-agent drug currently used for the treatment of this patient population and selected by the physician.

The trial was designed to examine the CR or uCR 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.

Cell Therapeutics (CTI) has an existing license and co-development agreement with Novartis for Opaxio, which also provides Novartis with an option to enter into an exclusive worldwide license to develop and commercialize pixantrone based upon agreed terms.

James Bianco, CEO of CTI, said: “Complete remissions in this patient population with end stage advanced disease are seldom accomplished with the current standard of care. Pixantrone, if successful in achieving the study objectives, could offer these patients a significant benefit, and we would work with the FDA to submit a new drug application in 2009.”