Celator Pharmaceuticals today announced that new data from a preclinical leukemia study in mice demonstrate that its lead product, CPX-351 (Cytarabine:Daunorubicin) Liposome Injection, alone or in combination with clofarabine or azacytidine can improve treatment outcomes compared to the combination of either agent with the conventional (unencapsulated) cytarabine:daunorubicin regimen. The results were presented at the 15th Congress of the European Hematology Association in Barcelona, Spain, June 10-13, 2010 (Abstract #718(1)).
"As prior research has demonstrated, the challenge of combining cytarabine:daunorubicin with other anti-leukemic agents is that the dosing adjustments necessary to avoid unacceptable toxicities may compromise treatment efficacy," said Lawrence Mayer, PhD, president and head of research at Celator Pharmaceuticals. "The results from this model demonstrate the enhanced efficacy and wider therapeutic window of CPX-351 compared to the conventional cytarabine:daunorubicin regimen."
The study was conducted in a human leukemia xenograft model (CCRF-CEM mice). Tumor-bearing mice were treated with either clofarabine or azacytidine alone or with one of these agents in combination with CPX-351 or a conventional cytarabine:daunorubicin regimen. Maximum tolerated dose assessments were made for clofarabine and azacytidine singly, and in both combinations. The dose of CPX-351 had to be reduced by 50 percent when combined with either agent to avoid mortality or unacceptable weight loss. The dose of conventional cytarabine:daunorubicin had to be reduced by 50 percent when combined with clofarabine and by 75 percent when combined with azacytidine.
Prolongation of median survival relative to treatment with the individual agents, the principle efficacy outcome, was substantially greater for CPX-351 alone and for CPX-351 in combination with either agent. CPX-351 alone resulted in a greater median survival than conventional cytarabine:daunorubicin, single agent clofarabine or single agent azacytidine, or the combination of conventional cytarabine:daunorubicin with either clofarabine or azacytidine. CPX-351 in combination with either clofarabine or azacytidine produced the longest median survival.
"CPX-351 has potent anti-leukemia activity alone and in combination with other drugs in development for the treatment of leukemia," said Scott Jackson, chief executive officer of Celator Pharmaceuticals. "Based on the positive results generated with CPX-351 in patients with acute myeloid leukemia, the Company is evaluating the product's potential for the treatment of other hematologic malignancies."
SOURCE Celator Pharmaceuticals, Inc.