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Pixantrone Produces 250% Relative Improvement in 1 Year Progression Free Survival for Patients With Relapsed/Refractory, Aggressive Non-Hodgkin's Lymphoma Across All Measured Risk Factors - Updated Follow-Up Data
Date:12/7/2009

b>Disease) 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 and selected by the physician.

Results of the PIX301 phase III trial presented demonstrated improvement across primary and secondary endpoints of the study at a minimum of nine-month follow-up from end of treatment. Pixantrone produced CR / CRu rate of 25.7% versus 7.1% for the comparator arm, p-value = 0.005. Overall response rate also increased significantly in patients that received pixantrone (40.0% pixantrone arm versus 14.3%, p-value=0.001). Median PFS increased 115% to 5.6 months for pixantrone arm compared to 2.6 for comparator arm, p-value = 0.002 and HR=0.56. Additionally, a positive trend was seen in overall survival with a 48% increase in median overall survival for the pixantrone arm (10.2 months) versus the comparator arm (6.9 months).

Results presented also included a patient subgroup analysis demonstrating that complete response (CR), partial response (PR) and PFS were robust irrespective of risk factors or prior therapy. Pixantrone also provided superior disease control rates over comparator arm with 22 of comparator recipients progressing within the first evaluation point versus 14 for pixantrone recipients.

Despite 50% of patients exceeding cumulative lifetime anthracycline limits (501 - 900 mg/m2), only two cases of congestive heart failure on independent cardiologist assessment were attributed to pixantrone, occurring at lowest drug exposure (<501mg/m2). The follow-up period for the study is ongoing.

"We are pleased that the PIX 301 EXTEND trial of pixantrone not only met its study objective but c
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SOURCE Cell Therapeutics, Inc.
Copyright©2009 PR Newswire.
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