Pixantrone Significantly Increases Complete Remissions, Overall Response Rates, Frequency of Durable Remissions and Progression Free Survival in Patients with Relapsed and Refractory Aggressive Non-Hodgkin'... (e chemotherapy treatment. We are...)

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Pixantrone Significantly Increases Complete Remissions, Overall Response Rates, Frequency of Durable Remissions and Progression Free Survival in Patients with Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma

Date:6/1/2009

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"We are pleased that the PIX 301 EXTEND trial of pixantrone demonstrated a long-lasting clinical benefit in this heavily pretreated relapsed/refractory group of patients with aggressive NHL and look forward to completing the New Drug Application submission later this month," said James A. Bianco, M.D., Chief Executive Officer of CTI. "Given the lack of approved therapies for this resistant group of patients with aggressive NHL, we believe pixantrone offers a valuable therapy for this unmet medical need."

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 ("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.

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SOURCE Cell Therapeutics, Inc.
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