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Responses After Completion of Therapy Increase Pixantrone Complete Remission (CR)/Unconfirmed Complete Remission (CRu) Rate to 24% and Overall Response Rate (ORR) to 40% Compared to 7% and 14% for Comparator Agents in Phase III EXTEND Trial in 3rd Line Th
Date:6/21/2009

arm achieved a confirmed complete remission at this point. The ORR was also significantly higher for patients treated with pixantrone and was 40% (28 of 70 patients) for pixantrone vs. 14.3% (10 of 70 patients) for standard chemotherapy with p=0.001. The follow-up period of this study is ongoing. CTI expects an additional update during late 2009.

In subgroup analyses, higher response rates in the pixantrone treatment group compared to comparator group were observed consistently across all of the following subgroups: age (<65 or >= 65 years old); whether the patient was refractory to last therapy; or whether the international prognostic index (IPI) score, a predictor of risk of disease recurrence and overall survival, was greater than or equal to 2. Patients greater than or equal to 65 years of age that received pixantrone achieved a CR/CRu rate of 26.1% (6 of 23 patients) and an ORR of 47.8% (11 of 23 patients) compared to no patients achieving a CR/CRu rate and an ORR of 5.6% (1 of 18 patients) for those that received standard chemotherapy. Furthermore, patients whose disease had relapsed and who had received pixantrone achieved a CR/CRu rate of 28.8% (8 of 28 patients) and an ORR of 50.0% (14 of 28 patients) compared to a CR/CRu rate of 6.7% (2 of 30 patients) and an ORR of 16.7% (5 of 30 patients) for those that received standard chemotherapy. Those patients whose disease was refractory to prior therapy and received pixantrone achieved a CR/CRu rate of 15% (6 of 40 patients) and an ORR of 30.0% (12 of 40 patients) compared to a CR/CRu rate of 5.0% (2 of 40 patients) and an ORR of 12.5% (5 of 40 patients) for those that received standard chemotherapy. Finally, in patients with an IPI score of greater than or equal to two, those patients that received pixantrone achieved a CR/CRu rate of 18.0% (9 of 50 patients) and an ORR of 32%(16 of 50 patients) compared to a CR/CRu rate of 5.9% (3 of 51 patients) and an ORR of 15.7% (8 of 51 patien
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SOURCE Cell Therapeutics, Inc.
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