The Company recently announced results of an interim analysis of the RAPID trial which showed that patients who received pixantrone had a reduction in severe (grade 3/4) side effects when compared to patients treated with standard doxorubicin-based therapy. Despite pixantrone patients receiving more treatment cycles, a three-fold reduction in the incidence of severe heart damage (LVEF decline >15 percent) was seen as well as clinically significant reductions in severe infections and febrile neutropenia.
The Data Safety Monitoring Committee, which met recently, recommended that the EXTEND study continue. The trial is expected to be completed by the end of 2007 with a full analysis during the first half of 2008. Since pixantrone has fast track status for relapsed, aggressive NHL, the drug could receive marketing approval in 2009.
About EXTEND (PIX301)
The EXTEND clinical trial is a phase III single agent trial of
pixantrone for patients with relapsed, aggressive non-Hodgkin's lymphoma
who have received two or more prior therapies and who are sensitive to
treatment with anthracyclines. The trial is being conducted at 130 sites in
17 countries. Patients are 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 is designed to examine
the complete response (CR) or unconfirmed complete response (uCR) rate,
time to tumor progression, and overall survival. The study was powered
based on a CR 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
initially anticipated the requirement of 320 patients to meet the
statistical assumptions of the trial. The study is being conducted under a
Special Protocol Assessment from the U.S.
|SOURCE Cell Therapeutics, Inc.|
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