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Celator(R) Pharmaceuticals Presents Phase 1 Results With CPX-351 in Patients With Advanced Leukemia at the American Society of Hematology Meeting
Date:12/9/2008

tality related to treatment is normally an issue when treating AML patients, there were no deaths within 7 days of treatment and 6 deaths (13%) within 30 days of receiving CPX-351. The induction mortality seen in the Phase 1 study was deemed encouraging by investigators. Major GI toxicity was uncommon with only 4 patients experiencing grade 3 or greater nausea and vomiting or mucositis.

Pharmacokinetic data collected during the study confirmed the bioavailability of cytarabine and daunorubicin, demonstrated a prolonged half-life for both drugs and their metabolites, and confirmed that the synergistic ratio was maintained for more than 24 hours after infusion.

The Phase 1 study enrolled 37 patients with advanced AML, secondary AML and ALL, during the dose-escalation phase. The maximum tolerated dose was established at 101 units/m2. An additional 10 patients were recruited and treated at this dose level to confirm tolerability and collect preliminary data on efficacy, bringing the total trial enrollment to 47. The recommended dose for Phase 2 study was determined to be 101 units/m2 given as a 90 minute infusion on treatment days 1, 3, and 5.

These findings were supported by a separate pre-clinical study that was also reported at the ASH meeting. Using a bone marrow engrafted human leukemia xenograft model, investigators compared CPX-351 with conventional cytarabine/daunorubicin treatment. The study confirmed that CPX-351, unlike the conventional combination, produced prolonged exposure of CPX-351 in the bone marrow and evidence of direct uptake of CPX-351 by leukemia cells with subsequent intracellular release of the drugs. Exposure of leukemic cells to synergistic drug ratios was confirmed.

In November, Celator announced enrollment of the first patient in a randomized Phase 2 study of CPX-351 versus conventional cytarabine and daunorubicin ("7 + 3") in patients with newly dia
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SOURCE Celator Pharmaceuticals
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