Fludarabine, Mitoxantrone and Zevalin(R) Produces 96% Complete Remission Rate in First-Line Treatment of Patients with Follicular Non-Hodgkin'... ( Phase II study of investigational r...)

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Fludarabine, Mitoxantrone and Zevalin(R) Produces 96% Complete Remission Rate in First-Line Treatment of Patients with Follicular Non-Hodgkin's Lymphoma

Date:3/16/2008

Phase II study of investigational regimen demonstrates important role of radioimmunotherapy in converting partial remissions to complete remissions

and inducing a high rate of molecular remissions

SEATTLE, March 17 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTA) today announced that patients with previously untreated follicular non-Hodgkin's lymphoma (NHL) treated with fludarabine and mitoxantrone, followed by administration of Zevalin(R) (Ibritumomab Tiuxetan), achieved 96 percent complete remission (CR), an estimated three-year progression-free survival (PFS) rate of 76 percent, and a 100 percent estimated three-year overall survival (OS) rate. The side effects were generally mild without any signs of cumulative toxicity, and hematological side effects were moderate. Results of the study were reported in the online edition of The Lancet (Lancet Oncology, DOI:10.1016/S1470-2045(08)70039-1). CTI acquired the U.S. rights to Zevalin in December, 2007.

The objective of the study was to determine the tolerability and efficacy of Zevalin consolidation following sequential fludarabine and mitoxantrone therapy without rituximab in first-line treatment of follicular NHL.

"This study underscores the potential use of radioimmunotherapy with Zevalin to convert the majority of partial remissions to complete remissions and to induce molecular remissions after conventional chemotherapy, both of which correlate with durable progression-free survival rates," noted Jack W. Singer, M.D., Chief Medical Officer at CTI.

A total of 61 patients with advanced (stage III-IV) follicular NHL were treated with six cycles of fludarabine and mitoxantrone chemotherapy; 57 patients (43 with CR and 14
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