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Preliminary Analyses from Phase 2 Genzyme Study Highlight Efficacy and Safety of Clofarabine in Older Adult AML Patients
Date:6/2/2008

ta show a 45 percent overall remission rate among patients treated with single agent clofarabine, with 40 percent of patients achieving a complete remission to therapy and 5 percent attaining a complete remission with incomplete platelet recovery. Overall remission in this study is defined as a patient achieving either complete remission or complete remission with incomplete platelet recovery. Secondary endpoints include duration of remission, disease free survival, overall survival, safety and thirty-day mortality. The CLASSIC II study data are based on clinical responses from 115 patients at 20 sites in the U.S.

Data also show overall remission rates of 50 percent among patients with prior blood disorders; 43 percent in patients with adverse cytogenetics; 40 percent in patients 70 years of age and older; and 38 percent in patients with an ECOG performance status of 2. Remission rates in patients with up to three pre-defined risk factors required for study enrollment also exceeded 40 percent.

The study also demonstrated that the toxicity profile of clofarabine was predictable and manageable. Drug-related adverse events occurring in more than 15 percent of patients included nausea, febrile neutropenia, vomiting, diarrhea and rash; most were grade 1 or 2. As expected, Grade 4 neutropenia and thrombocytopenia occurred in a majority of patients. Only five of 115 patients discontinued treatment due to an adverse event or toxicity precluding further therapy. The study has completed enrollment and patients are being followed for remission duration, disease-free survival and overall survival. An independent panel of hematologists and hematopathologists are confirming the investigators' assessment of responses.

"In addition to the excellent overall safety and efficacy findings we are observing with single agent clofarabine, we also see impressive responses in older patients with poor prognostic cytogenetic abnormalities when treated with the drug," stat
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SOURCE Genzyme Corp.
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