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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

First Randomized Trial to Demonstrate Superior Clinical Benefit in Relapsed/Refractory Aggressive NHL

ORLANDO, Fla., June 1 /PRNewswire-FirstCall/ --

Intent to treat Analysis results per FDA agreed upon Statistical Analysis Plan

  • Significant Increase in Complete Remission Rates 20% vs. 5.7%; p=0.021
  • Significant Increase in Overall Response Rate 37.1% vs. 14.3%; p=0.003
  • Significant increase in percent of all patients whose response lasted greater than or equal to four months 25.7% vs. 8.6%; p=0.012
  • Significant Increase in Progression Free Survival 4.7 months vs. 2.6 months; p=0.007
  • Positive trend in Overall Survival even though data not fully mature with median 8.1 month vs. 6.9 month; p=0.544

Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that at the 2009 American Society for Clinical Oncology ("ASCO") Annual Meeting for the first time since the top-line data were released, complete pivotal phase III results of CTI's EXTEND (PIX 301) clinical trial of pixantrone (the "PIX 301 EXTEND trial") in relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL") were presented by Principal Investigator, Ruth Pettengell, M.D. of St. George's Hospital, University of London, the lead investigator for the PIX 301 EXTEND trial who presented the study at ASCO.

"Anthracycline-related drugs can be effective salvage agents in aggressive NHL, but our use of them is limited by the significant increase in risk of cardiac failure associated with high cumulative doses of these drugs," said Dr. Pettengell. "These results represent a breakthrough in that pixantrone could extend our ability to use a highly active anthracycline-like drug in such patients and deserves to be examined in anthracycline naive patien
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SOURCE Cell Therapeutics, Inc.
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