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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

Data Show Encouraging Results for a Potential New Front-Line Treatment

Approach in AML

CAMBRIDGE, Mass., June 2 /PRNewswire-FirstCall/ -- Genzyme Corp. (Nasdaq: GENZ) reported preliminary data today from a fully-enrolled pivotal, phase 2 study examining the safety and effectiveness of Clolar(R) (clofarabine) as a single agent in previously untreated, older adult patients with acute myelogenous leukemia (AML) who are unlikely to benefit from conventional "7+3" anthracycline plus cytarabine-based induction chemotherapy.

Results from the CLASSIC-II clinical trial show that patients with unfavorable prognostic factors who received single agent clofarabine exhibited a 45 percent overall remission rate based on investigator assessment, with manageable treatment-related side effects. Importantly, the 30 day all-cause mortality, one of the secondary endpoints in this study, was only 9.6 percent, which compares favorably to existing treatment options. Data from the study were presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

"The therapeutic outcomes for older AML patients have not improved in the past thirty years," stated Mark J. Enyedy, president of Genzyme Oncology, a business unit of Genzyme Corporation. "These data highlight the potential of clofarabine to become an innovative and much needed treatment option for these patients. We look forward to submitting a supplemental new drug application in the United States later this year to expand the current product label into front-line therapy for adult AML and to make a similar filing in Europe around this same time."

Study Results

As reported at ASCO, investigator-assessed response da
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SOURCE Genzyme Corp.
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