Discussions With FDA on Pixantrone EXTEND (PIX301) Trial Provide Path for NDA ...(omized trial of pixantrone versusdoxorub...)

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.
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