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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

tigational regimen which replaces doxorubicin with pixantrone, CPOP-R (cyclophosphamide, pixantrone, vincristine, prednisone, and rituximab) monthly for six cycles. During treatment, patients are evaluated for response to therapy after cycle 4 and at the end of treatment. During follow up disease status is assessed every three months during first year and every six months thereafter.

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 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. Members of the independent Data Safety Monitoring Board (DSMB) review safety data on a quarterly basis.

Pixantrone in Clinical Studies

There are currently two clinical studies of pixantrone in aggressive NHL patients, RAPID and a phase III single agent trial, known as EXTEND. The EXTEND trial explores the role of single-agent treatment as a salvage regimen in patients with relapsed aggressive NHL who have failed at least two prior treatment regimens. Patients are randomized to receive either pixantrone or another single-agent drug of the physician's choice currently used for the treatment of this patient population.

A phase III trial of pixantrone for patients with indolent NHL was launched in September 2007. The trial, PIX303, will examine the complete remission rates and time to disease progression for the combination regimen of fludarabine, pixantrone and rituximab (FP-R) compared to the combination of fludarabine and rituximab (F-R) in the treatment of patients who have r
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SOURCE Cell Therapeutics, Inc.
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