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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

istered as 30mg/m2 per day for five consecutive days then, based on their response, received up to five additional cycles of treatment at a dose of 20 mg/m2 per day for five consecutive days.

Significant Unmet Medical Need

The CLASSIC II study is designed to address a high unmet medical need among older AML patients who currently have limited treatment options. According to the American Cancer Society, each year approximately 6,500 people over the age of 60 are diagnosed with AML in the U.S. The median survival for those receiving therapy can vary from one to thirteen months, and the five-year survival rate over the past three decades remains at less than 10 to 15 percent. Older AML patients often have disease features such as unfavorable (adverse) cytogenetics and pre-existing blood disorders such as MDS that result in lower response rates and worse treatment outcomes to conventional induction chemotherapy compared with younger patients. In addition, conventional induction chemotherapy is poorly tolerated in older patients with unfavorable risk factors, and early induction mortality usually ranges from 10-30 percent but can exceed 30 percent in older patients with a poor performance status.

This study builds on promising results from two prior studies of single agent clofarabine in previously untreated older patients with AML deemed unfit for chemotherapy, based mostly on poor performance status and presence of co-morbid illnesses. These studies were conducted by Alan Burnett, M.D., of Cardiff University in the United Kingdom and presented at earlier American Society of Hematology meetings.

Clolar Clinical Development

A separate, phase 3 pivotal study (CLASSIC I) of clofarabine in relapsed adult AML patients aged 55 and older and previously treated with at least one, but not more than two, prior induction regimens is underway. This randomized, double-blind, placebo-controlled study will compare the combination of clofarabine and c
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SOURCE Genzyme Corp.
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