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Cell Therapeutics, Inc. (CTI) Announces Enrollment Complete in Phase III EXTEND (PIX301) Clinical Trial of Pixantrone in Patients With Second or Greater Relapse of Diffuse Large B Cell NHL
Date:3/24/2008

Potential NDA Submission in 2009

SEATTLE, March 25 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTA) announced today that enrollment is complete in the phase III EXTEND (PIX301) clinical trial of pixantrone (BBR2278) for patients with relapsed diffuse large B cell non-Hodgkin's lymphoma (NHL). An analysis of the data is expected in the second half of 2008. Based on prior discussions with the U.S. Food and Drug Administration (FDA) the data could provide a registration path for pixantrone if final study results are adequate for submitting a New Drug Application (NDA) with the FDA in early 2009 with a potential approval in 2009. A total of 140 patients were enrolled in the study, 97 patients are currently evaluable according to Histological Intent to Treat, or HITT, criteria and will be included in the final analysis of the study.

"PIX301 examines the effectiveness of pixantrone in patients with relapsed and refractory diffuse large B cell lymphoma, a population where current therapies seldom induce complete remissions," said Jack W. Singer, Chief Medical Officer at CTI. "Based on a blinded current independent assessment of events in the trial we believe we have an adequate sample size of eligible patients to meet the primary objective of the trial."

About the EXTEND (PIX301) Clinical Trial

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. Patients were randomized to receive either pixantrone or another single-agent drug currently used
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SOURCE Cell Therapeutics, Inc.
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