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PRINCETON, N.J., June 8 /PRNewswire/ -- Celator Pharmaceuticals today announced that new clinical and preclinical data demonstrating the extended therapeutic bioavailability and tumor cell selectivity of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection in leukemia were presented at the 14th Congress of the European Hematology Association (EHA) in Berlin, Germany, June 4-7, 2009 (Abstracts 1398 and 383).
"These findings underscore the potential pharmacological and pharmacokinetic advantages of CPX-351 in the treatment of advanced leukemias," said Scott Jackson, chief executive officer, Celator Pharmaceuticals. "Our nano-scale liposomal encapsulation maintains the desired 5:1 molar ratio of cytarabine:daunorubicin in CPX-351, extends bioavailability beyond that seen with conventional administration of the combination, and, based on this evidence, facilitates selectivity for and uptake by leukemia cells. As a result, CPX-351 may lengthen or enhance the anti-tumor activity of cytarabine:daunorubicin, even in patients with relapsed and refractory disease."
The first poster presented data on the pharmacokinetics and pharmacology of CPX-351 from a Phase I study of patients with relapsed or refractory acute leukemias.(1) Evidence of antitumor effect, details of which were presented at the American Society of Hematology (ASH) meeting in late 2008, included complete remissions (CRs) in 1 of 3 patients with ALL and 10 of 44 patients with AML (9 CRs and 1 CRp - complete remission without full platelet recovery). Some of these remissions occurred at dose levels as low as one-third to one-half of the maximum tolerated dose (MTD; established in this study as 101 u/m(2)). Treatment with CPX-351 was generally well tolerated, with cytopenia-related adverse events consistent with standard cytarabine:daunorubicin regimens. Alopecia and grade greater than or equal to 3 gastrointestinal adverse events were uncommon.
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