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Pixantrone Combination Therapy for First-line Treatment of,Aggressive Non-Hodgkin's Lymphoma Results in Reduction in Severe,Toxicities Including Heart Damage When Compared to,Doxorubicin-based Therapy

phoma, and leukemia, where debilitating cardiac damage from doxorubicin might be prevented. We look forward to discussing these results and our planned interim analysis of the PIX301 (EXTEND) pivotal trial with the FDA. We believe the RAPID data coupled with the EXTEND data may provide sufficient clinical information for review of pixantrone in aggressive NHL."

Details of the RAPID Trial

The RAPID (Replacing Adriamycin with Pixantrone to Improve Safety in NHL Disease) trial is a 280-patient randomized controlled phase II/III combination study 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 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 investigational regimen which replaces doxorubicin with pixantrone, CPOP-R (cyclophosphamide, pixantrone, vincristine, prednisone, and rituximab) monthly for six cycles. Patients are evaluated for response to therapy every two cycles and evaluated every two months following completion of therapy.

Cardiac function, as determined by serial multi-gated nuclear scans (MUGA), is evaluated prior to initiation of therapy and then at the completion of every two cycles of therapy. Thus far, routine prophylactic administration of G-CSF was utilized equally across treatment arms in approximately half of study participants. The interim analysis was conducted after approximately 60 patients completed at least four cycles of therapy to determine if the dose of pixantrone (150 mg/m2) was adequate to induce major objective responses comparable to the doxorubicin arm as well as to evaluate potential differences in major toxicities.

Pixantrone in Clinical Studies

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