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Low Occurrence of Severe Cardiac Side Effects Despite Extensive Prior Doxorubicin Treatment Reported in Pixantrone Pivotal Trial
Date:5/19/2009

;=300 mg/m2 5.6% 2/68 500 mg/m2 15% 2/43 600 mg/m2 32% 0/36 >600 48% 1/25 (1) Cancer 97: 2869, 2003

The EXTEND clinical trial was a phase III single-agent trial of pixantrone for patients with relapsed, 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.

CTI previously announced that its pivotal phase III (PIX 301) EXTEND trial had achieved its primary endpoint with patients randomized to treatment with pixantrone achieving a significantly higher rate of confirmed (CR) and unconfirmed complete remissions (CRu) compared to patients treated with standard chemotherapy (14/70 (20.0%) for pixantrone arm compared to 4/70 (5.7%) for the standard chemotherapy arm, p = 0.02) with no patients in the standard chemotherapy arm achieving a confirmed complete remission.

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. Disease progression reported as an adverse event was less frequent in the pixantrone than in the control arm (1.5% vs. 13.4%).

CTI will be presenting additional new efficacy and safety data at the u
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SOURCE Cell Therapeutics, Inc.
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