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Compared to Standard Therapies, Pixantrone Decreases Time to Achieve Complete Remission by 47% in Relapsed Aggressive Non-Hodgkin's Lymphoma
Date:2/17/2009

SEATTLE, Feb. 18 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) announced today that updated safety and efficacy data from the phase III trial of pixantrone provides further support for a robust clinical benefit for pixantrone when used as single agent therapy in the treatment of multiple relapsed aggressive non-Hodgkin's lymphoma (NHL). On an intent-to-treat analysis, pixantrone recipients who achieved a complete remission did so during the first 2 cycles of therapy, compared to 4 cycles among standard chemotherapy recipients, (1.9 months vs. 3.6 months, pixantrone vs. standard chemotherapy). The duration of response in the patients was similar in the 37% of pixantrone patients who had either a partial or complete response compared to the 14% of comparator patients with a major response. However, the overall progression free survival (PFS) was significantly longer in the pixantrone arm (4.7 months vs. 2.6 months, hazard ratio = 0.6; p = 0.0074, pixantrone vs. standard chemotherapy). Thirty-two percent (32%) of pixantrone patients received all 6 cycles of therapy, with 84% receiving 5 of 6 cycles of treatment. Pixantrone recipients had a low incidence of severe neutropenia complicated by either fever or documented infections, or severe vomiting or diarrhea. Pixantrone patients also experienced a low incidence of hair loss, a very common side effect of other drugs in this class. Overall, the incidence of serious adverse events was similar between pixantrone and the control arm. The pixantrone patients had a higher incidence of leucopenia and neutropenia and numerically more severe cardiac events (4 vs 2) than in the control arm. Disease progression reported as an adverse event was less frequent in the pixantrone than in the control arm (1.5% vs. 13.4%).

"We were impressed to see that 84% of patients received at least 5 cycles of pixantrone therapy with a median total dose of 1,475 mg, despite
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SOURCE Cell Therapeutics, Inc.
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