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Celator(R) Pharmaceuticals Reports CPX-351 Shows Anti-Cancer Activity in Leukemia Patients
Date:12/10/2007

Results from ongoing Phase I study of advanced leukemia and myelodysplastic syndrome patients presented at American Society for Hematology meeting.

PRINCETON, N.J., Dec. 10 /PRNewswire/ -- Celator Pharmaceuticals today announced results from an ongoing Phase I study of CPX-351, a liposomal formulation that incorporates a synergistic ratio of cytarabine and daunorubicin for the treatment of advanced leukemias and myelodysplastic syndromes. While dose escalation in the study is ongoing, thus far three patients treated with CPX-351 have achieved complete remissions (CR), one patient has achieved a CRp (complete remission where platelets did not recover to greater than 100,000 platelets per microliter), and two additional patients achieved partial remissions (PR).

The study included patients with relapsed/refractory acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and high-risk myelodysplastic syndrome (MDS). All but three of the 27 patients had AML. The majority of patients were older than 60 years of age, including four patients older than 75. All patients had relapsed or refractory disease, with 15/27 having received two or more prior induction therapies. After their last therapy, 19/27 had no response and 8/27 achieved a CR. CPX-351 has been safely administered up to and including 101 units/m2 (=101 mg/m2 of cytarabine and 44mg/m2 of daunorubicin). Non-hematologic adverse events included stomatitis (10/27 patients), skin rash (10/27), diarrhea (9/27), nausea (7/27), vomiting (5/27) and alopecia (2/27). The study has shown that CPX-351 is capable of inducing marrow aplasia with few severe non-hematologic adverse events.

"CPX-351 is a provocative new treatment approach for patients with AML," said Eric Feldman, MD, from Weill Medical College of Cornell University and New York Presbyterian Hospital and an investigator in the Phase I study. "The data from the Phase I study in highly refractory AML patients are encouraging, includi
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