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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

ed Harry P. Erba, MD, Ph.D., University of Michigan, one of the co-principal investigators for this study. "This study helps to define a new approach to treatment for patients unlikely to benefit from conventional 7+3 induction chemotherapy and provides support for the importance of assessing cytogenetics prior to induction treatment."

"The positive results seen in this study provide a compelling case for a novel, effective, therapeutic option for older adult patients with AML who have multiple unfavorable prognostic factors," added Hagop Kantarjian, M.D. MD Anderson Cancer Center and the other co-principal investigator for the CLASSIC II study. "In our published research from MD Anderson, older AML patients with one to three unfavorable prognostic factors are at risk of lower complete remission rates and higher 60-day mortality. We look forward to analyzing the final independently-assessed study results, particularly the remission duration data, for this very difficult-to-treat population."

In addition to presentation at ASCO, a podium appearance of the preliminary CLASSIC-II data also will be delivered by Dr. Erba at the upcoming European Hematology Association meeting in Copenhagen, Denmark on Sunday, June 15.

Study Design

Patients in the CLASSIC-II study must have previously untreated AML, be 60 years or older and be unlikely to benefit from conventional induction chemotherapy based on the presence of at least one of the following adverse prognostic factors: age greater than or equal to 70, pre-existing hematological disorder such as myelodysplastic syndrome (MDS), poor health performance, or intermediate or unfavorable cytogenetics. Patients also had to be previously untreated and unlikely to benefit from conventional induction chemotherapy (7+3 anthracycline plus cytarabine) based on the presence of at least one of these poor prognostic factors at baseline.

Patients received an induction cycle of intravenous clofarabine admin
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SOURCE Genzyme Corp.
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