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Pixantrone Increases Progression-Free Survival by 81% Compared to Standard Chemotherapeutic Agents in Phase III Relapsed Aggressive non-Hodgkin's Lymphoma Trial
Date:1/27/2009

14.3%) for the control arm, p = 0.003). PFS, CR/CRu and ORR were determined by an independent assessment panel that was blinded to the treatment assignments.

The most common serious toxicities (>5%) seen in previous trials of pixantrone include grade 3 and 4 neutropenia and febrile neutropenia. Complete safety information is not yet available for the study, however, the study was monitored on an ongoing basis by an independent Data Safety Monitoring Committee and no serious concerns were raised.

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 enrolled 140 patients and 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 complete remission or unconfirmed complete remission rate, overall survival and progression-free survival. The study received Special Protocol Assessment approval from the FDA in 2004 and pixantrone has received fast track designation for this indication.

The Company announced on January 27, 2009 that after a pre-NDA communication with the FDA, it expects to begin submission of a rolling NDA and request priority review for pixantrone to treat relapsed aggressive NHL in the first quarter of 2009.

About Pixantrone

Pixantrone (BBR 2778), a DNA intercalating antitumor agent that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents, was discovered by our scientists in Bresso, Italy. Pixantrone is a novel DNA major groove binder that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents. Anthracycl
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SOURCE Cell Therapeutics, Inc.
Copyright©2009 PR Newswire.
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