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Celator(R) Pharmaceuticals Enrolls First Patient in Its Phase 2 Study of CPX-351 in Acute Myeloid Leukemia in First Relapse
Date:3/10/2009

The study is supported by The Leukemia & Lymphoma Society(R)

PRINCETON, N.J., March 10 /PRNewswire/ -- Celator Pharmaceuticals today announced that the first patient has been treated in its Phase 2 multicenter, randomized, open-label clinical trial of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection versus intensive salvage therapy in adult patients (up to 60 years old) with acute myeloid leukemia in first relapse. As previously announced, the study is being supported through a partnership with The Leukemia & Lymphoma Society (LLS).

The first patient was enrolled by Maureen Cooper, M.D., at St. Francis Hospital in Beech Grove, Indiana. "We are pleased to be participating in this study and eager to collect additional clinical evidence demonstrating the benefit of delivering and maintaining a synergistic ratio of these two widely used drugs for the treatment of AML," said Dr. Cooper.

"CPX-351 represents a unique approach to enhancing the clinical benefit of the two most active drugs used in the treatment of patients with AML," said Jonathan Kolitz, M.D., Director of the Leukemia Service at North Shore University Hospital and lead investigator for the study. "There is no standard of care established for patients in first relapse. We expect that this study will build on the promising results initially obtained in this patient population in the Phase 1 study and provide additional confirmation of the clinical benefit of CPX-351."

The study (Protocol CLTR0308-205) will enroll up to 120 patients between the ages of 18 and 60 who have pathological confirmation of relapsed AML after an initial complete response to prior therapy lasting at least one month. Patients will be randomized (2:1) to receive either CPX-351 (100u/m2; Days 1, 3, 5) or one of several control arm regimens, including high dose cytarabine with or without daunorubicin; conventional "7+3" (cytarabine/daunorubicin reg
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SOURCE Celator Pharmaceuticals
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