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Pixantrone Versus Doxorubicin in CHOP-R Therapy for First-line Treatment of Aggressive Non-Hodgkin's Lymphoma Preliminary Results Presented at American Society of Hematology (ASH) Annual Meeting
Date:12/11/2007

i-tumor activity to CHOP-R with fewer severe side effects. In the interim analysis, 78 patients were evaluated for safety and 40 patients were evaluated for efficacy. A reduction in the incidence of severe heart damage (LVEF decline >15 percent, 2/36 patients for CPOP-R vs. 7/36 patients for CHOP-R) was seen. Declines in LVEF greater than or equal to 10% have occurred equally in both arms (8 patients each). In addition, reductions in grade 3 infections (2 patients for CPOP-R vs. 7 patients for CHOP-R) and febrile neutropenia (2 patients for CPOP-R vs. 7 patients for CHOP-R) were reported in this early interim analysis.

Based on investigator assessments after four cycles of therapy, 40 patients were evaluated for efficacy, of which 33 percent achieved a complete response (CR) and 53 percent achieved a partial response (PR) on the CPOP-R arm (n=21) compared to 32 percent achieving a CR and 52 percent achieving a PR on the doxorubicin arm (n=19).

There were three deaths within 30 days of the last dose of study treatment on the CPOP-R arm. Two of the events were attributed to study treatment (pneumonia concurrent with neutropenia and non-cardiogenic pulmonary edema concurrent with non-neutropenic infection). No deaths within 30 days of the last dose of the study drug were reported in the CHOP-R arm.

Details of the RAPID Trial

The RAPID (Replacing Adriamycin with Pixantrone to Improve Safety in NHL Disease) trial is a randomized controlled phase II/III combination study in up to 280 patients investigating whether the substitution of pixantrone for doxorubicin in the first-line treatment of patients with advanced aggressive NHL can provide a comparable major response rate while reducing known clinically important doxorubicin-related toxicities. This multi-center international trial randomizes newly diagnosed patients to either the standard of care regimen CHOP-R (cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab) or an inves
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SOURCE Cell Therapeutics, Inc.
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