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Cell Therapeutics Completes Pixantrone NDA Submission and Requests Priority Review
Date:6/23/2009

Completed NDA submission could lead to marketing approval in Q4-2009

SEATTLE, June 24 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that it has completed the submission of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for pixantrone to treat relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL). CTI requested priority review, which if granted could lead to an approval decision from the FDA in the fourth quarter of 2009. Pixantrone is currently available in Europe on a named-patient basis.

"This is a major milestone for CTI and is the cornerstone of a turnaround strategy for us in meeting our goals of becoming a profitable operating business," said James A. Bianco, M.D., Chief Executive Officer of CTI. "With more than 76,000 pages and 500,000 hyperlinks this submission represents the hard work of many CTI employees dedicated to making a difference in the lives of patients with cancer. This also represents a significant advance in the treatment of patients with relapsed/refractory aggressive NHL, a patient population which the FDA has acknowledged represents an unmet medical need."

About the PIX 301 EXTEND Trial

CTI's EXTEND (PIX 301) clinical trial (the "PIX 301 EXTEND trial") was a phase III single-agent trial of pixantrone for patients with relapsed or refractory, aggressive NHL 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 as selected by the physician.

CTI previously announced that its pivotal PIX 301 EXTEND trial had achieved its primary endpoint with patients randomized to treatment with pixantrone achieving a significantly higher rate of confirmed (CR) an
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SOURCE Cell Therapeutics, Inc.
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