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Pixantrone Produces High Rates of Complete and Partial Remissions Even Among Aggressive NHL Patients With Extensive Prior Doxorubicin Treatment or Prior Rituximab Treatment
Date:6/1/2009

compared to patients treated with standard chemotherapy (14 out of 70 patients (20.0%) for the pixantrone arm compared to four out of 70 patients (5.7%) for the standard chemotherapy arm, p=0.02) with no patients in the standard chemotherapy arm achieving a confirmed complete remission.

The most common grade 3, 4 adverse event observed on the pixantrone arm was neutropenia in 41.2% of patients versus 19.4% on the comparator arm. However, the incidence of grade 3, 4 febrile neutropenia was only 7.4% versus 3.0% in the comparator arm. Grade 3, 4 infections had a similar incidence in both study arms (18% vs. 13%). Although the grade 3, 4 cardiac disorder was similar among the two treatment groups (1.5% vs. 1.5%), there was a slightly higher incidence of serious cardiac disorders in patients treated with pixantrone than among patients who received comparator agents (8.8% vs. 4.5%). Events considered cardiac disorders included cardiac arrest, congestive heart failure, myocardial infarction, cyanosis, pericardial effusion, and tachycardia.

The ASCO poster is available at http://www.celltherapeutics.com/investor_updates.

In April 2009, CTI began a rolling submission of a New Drug Application (the "NDA") with the U.S. Food and Drug Administration (the "FDA") for pixantrone to treat relapsed or refractory aggressive NHL. CTI expects to complete the submission this month and will request priority review, which if granted could lead to an approval decision from the FDA in the fourth quarter of 2009.

Pixantrone is also now available in Europe on a named patient basis.

About Pixantrone

Pixantrone (BBR 2778), is a novel major groove binder with an aza-anthracenedione molecular structure that differentiates it from the anthracyclines and other related chemotherapy agents. Anthracyclines are t
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SOURCE Cell Therapeutics, Inc.
Copyright©2009 PR Newswire.
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