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Genzyme begins Clolar study in leukemia patients

Genzyme Corporation has begun a phase II trial examining the safety and effectiveness of Clolar in previously untreated, older adult patients with acute myelogenous leukemia.

This is the second pivotal clinical study of Clolar in adult patients with acute myelogenous leukemia (AML) to commence this year, and Genzyme expects it to provide substantial support for expanding the current product label.

“Significant data from investigator-sponsored clinical trials have already been presented regarding the use of Clolar in adult AML and show very encouraging results,” stated Mark Enyedy, senior vice-president of Genzyme Oncology.

The trial is designed to address a high unmet medical need among older AML patients who currently have limited treatment options.

“Standard therapies for AML in this population are unsatisfactory. Older patients are often faced with treatment choices at either end of the spectrum: either toxic combination chemotherapy that has a high chance of treatment-related morbidity and mortality despite a low chance of cure, or very shortened survival with supportive care alone,” said Hagop Kantarjian, of The University of Texas MD Anderson Cancer Center.