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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

s in the 1st salvage setting (patients in first relapse or with refractory disease) and 3 CRs were achieved in 22 patients in the 2nd or greater salvage settings. In addition, CRs were observed in patients older than 70 years, in those with complex cytogenetic abnormalities, and in patients with prior cytarabine/anthracycline treatment.

"The standard of care for AML hasn't changed in 30 years and there is an urgent need to improve treatment for both newly diagnosed and relapsed patients," said Arthur Louie, MD, chief medical officer at Celator Pharmaceuticals. "We began enrolling patients in a Phase 2 study in newly diagnosed, elderly patients with AML and we expect to start enrollment soon in a Phase 2 study in patients with AML in first relapse."

CPX-351 represents a new approach to developing drug combinations in which drug molar ratios with synergistic anti-tumor activity are encapsulated in a drug delivery vehicle and the desired ratio is maintained following administration using Celator's proprietary CombiPlex(R) technology platform. CPX-351 has been granted orphan drug status by the U.S. Food & Drug Administration for the treatment of AML.

"CPX-351 incorporates two of the most active agents against AML in a manner that, as we've shown in this study, maintains ratio-dependent synergy after administration," said Scott Jackson, chief executive officer, Celator Pharmaceuticals. "We believe this unique capability has the potential to improve treatment outcomes for patients and we are looking to our randomized Phase 2 trials for proof of this principle."

The safety profile of CPX-351 observed in the study was considered favorable. The most frequent and severe adverse events were those related to potential or documented infections including fever, febrile neutropenia, bacteremia, pneumonia and sepsis, common occurrences in the treatment of patients with AML. Although, mor
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SOURCE Celator Pharmaceuticals
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