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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

ts as a potential alternative to currently available standard anthracycline drugs."

The PIX 301 EXTEND (Expanding the reach of antrhacyclines with piXanTronE in relapsed or refractory aggressive NHL 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.

In the PIX 301 EXTEND trial 57% of the randomized patients were refractory to prior treatments with 50% of patients having failed three prior chemotherapy treatments. More than 70% of the patients on both arms were considered intermediate to high risk by the International Prognostic Index score (>=2). The median prior doxorubicin equivalent dose was approximately 300 mg/m2, the dose that is associated with six cycles of CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy, the standard of care for first line therapy in this disease. Fifty-three percent of pixantrone patients received four or more cycles of therapy compared to a median of three cycles in the comparator arm. The median doxorubicin equivalent dose at the end of therapy was 513 mg/m2 (with a range of 115 mg/m2 to 1003mg/m2). Data from repeated evaluations of Left Ventricular Ejection Fraction ("LVEF") by MUGA (Multi Gated Acquisition Scan) scan demonstrated no consistent dose related decline as has been described for doxorubicin with median LVEF values at a baseline of 58% and at the end of treatment of 59%. Consistent across the primary and subgroup analyses, treatment with pixantrone resulted in superior clinical benefits over standard of car
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SOURCE Cell Therapeutics, Inc.
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