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Cell Therapeutics' Pixantrone Phase III (EXTEND) Pivotal Trial Successful in Achieving Primary Endpoint
Date:11/10/2008

I study is validation of Cell Therapeutics Inc.'s capabilities in acquiring attractive drug candidates, and designing and implementing a successful phase III trial," said James A. Bianco, M.D., CEO of Cell Therapeutics. "These data are consistent with the extensive experience with pixantrone in our phase I and phase II studies and demonstrate the ability to offer patients with advanced, relapsed NHL the potential to obtain a clinically meaningful response like a complete remission, despite having failed multiple other courses of chemotherapy or immuno-chemotherapy."

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 was conducted at 130 sites in 17 countries. 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 (CR) or unconfirmed complete remission (uCR) rate, overall survival (OS) and progression-free survival (PFS). The study received Special Protocol Assessment approval from the U.S. Food and Drug Administration (FDA) in 2004 and pixantrone has received fast track designation for this indication.

CTI intends to further evaluate additional details of the study and will provide complete safety and progression-free survival information comparing treatment assignments which is currently being assembled for analysis.

Cell Therapeutics will be presenting at the Rodman & Renshaw Healthcare Conference on November 11, 2008 at 10:45 am Eastern time and a webcast will be available at http://www.celltherapeutics.com.

About Pixantrone

Pixantrone (BBR 2778), a DNA intercalating antit
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SOURCE Cell Therapeutics, Inc.
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