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Genzyme Completes Enrollment in Pivotal, Phase 2 Clinical Trial of Clofarabine in Adult AML
Date:12/5/2007

CAMBRIDGE, Mass, Dec. 5 /PRNewswire-FirstCall/ -- Genzyme Corp. (Nasdaq: GENZ) announced today that the company has completed enrollment of a phase 2 clinical trial examining the safety and effectiveness of Clolar(R) (clofarabine) in previously untreated, older adult patients with acute myelogenous leukemia (AML) who are unlikely to benefit from standard induction therapy. Data from this study are expected to provide substantial evidence for expanding the current product label into adult AML.

"We are very pleased to have reached this milestone and to have done so in a timeframe that we expect will allow us to present preliminary data at ASCO next spring," stated Mark Enyedy, president of Genzyme Oncology. "The completion of patient enrollment in this clinical study is another important step in our plan to broaden the Clolar label to benefit a larger patient population and address multiple lines of adult AML."

Genzyme has held preliminary discussions with the U.S. Food and Drug Administration in advance of submitting a supplemental new drug application (sNDA) for clofarabine as an initial treatment in older adults with AML. The company expects to file this sNDA in the second half of next year.

Significant Unmet Medical Need

The clinical trial, known as CLASSIC II, 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 15 percent. Old
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SOURCE Genzyme Corp.
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