GENZYME BEGINS PHASE III STUDY OF CLOLAR IN OLDER AML PATIENTS

Genzyme announced that the first patient has been treated in a new Phase III clinical trial examining the safety and effectiveness of Clolar (clofarabine) in older patients with acute myelogenous leukemia (AML). This is the first clinical study of clofarabine in adult patients with AML and is expected to provide substantial support for expanding the current product label.

The trial, designed for AML patients ages 60 and older previously treated with at least one, but not more than two, induction regimens, is a randomized, double-blind, controlled study that will compare the combination of Clolar and cytarabine (Ara-C) to cytarabine alone. The study will take place at approximately 100 medical centers in the United States and Canada. It will enroll up to 376 patients with refractory or relapsed AML.

In addition to safety, the trial will evaluate the effectiveness of one dose of 40 mg/m2 per day of Clolar combined with 1 g/m2 per day of Ara-C, compared with 1g/m2 per day of Ara-C combined with placebo. The primary endpoint is improved overall survival. Other endpoints include overall remission rate, duration of remission, disease-free survival, event-free survival and safety and tolerability. All patients will be followed for at least two years after their end of treatment visit.

Clolar is currently indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens.