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Celator Pharmaceuticals today announced that it has completed enrollment in a phase 2 multicenter, randomized, open-label clinical trial of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection versus intensive salvage therapy in adult patients with acute myeloid leukemia (AML) in first relapse. The study, which is supported through a partnership with The Leukemia & Lymphoma Society® (LLS), achieved its target enrollment of 120 patients.
"We need new options for patients with AML in first relapse, as none of the regimens we currently use have been shown to provide an advantage in extending survival," said Jonathan E. Kolitz, MD, Director of the Leukemia Service at the Don Monti Division of Hematology/Division of Oncology, Monter Cancer Center, Hofstra North Shore-LIJ School of Medicine, and the study's principal investigator. "Based on promising data from a phase 1 study and an initial phase 2 trial in newly diagnosed AML, we are hopeful that CPX-351, which maintains two drugs that are very active against AML in a unique synergistic ratio after administration, can improve clinical outcomes for these patients."
The phase 2 study (Protocol CLTR0308-205) enrolled patients between the ages of 18 and 65 who had pathological confirmation of relapsed AML after an initial complete response to prior therapy lasting at least one month. Patients were randomized (2:1) to receive either CPX-351 (100u/m2; Days 1, 3, 5) or one of several control arm regimens, including high dose cytarabine with or without daunorubicin; conventional "7+3" (cytarabine/daunorubicin regimen); "MEC," the mitoxantrone/etoposide/cytarabine regimen; and other published salvage regimens. The primary efficacy endpoint of the study is the comparison of overall survival at 1 year between the two arms. Secondary endpoints include complete remission (CR) rate and duration, 30, 60, and 90-day mortality, event-free survival, aplasia rate, and rate of transfer for stem cell transplant. Patients are monitored for clinical adverse events as well as laboratory evaluations.
The study was conducted at leading institutions in North America and Europe, with the first patient enrolled in March 2009.
"Completion of this second phase 2 study is an important milestone for Celator and provides additional insight that will allow us to consider the design of pivotal trials," said Scott Jackson, chief executive officer, Celator Pharmaceuticals. "I want to extend our thanks to the investigators and patients who have participated in this study, as well as to our partner, LLS, for their support. We look forward to presenting results from this study in 2011."
About Celator Pharmaceuticals
Celator Pharmaceuticals, Inc., with locations in Princeton, NJ, and Vancouver, BC, is a privately held pharmaceutical company developing new and more effective therapies to treat cancer. CombiPlex®, the company's proprietary drug ratio technology platform, represents a novel approach that identifies molar ratios of drugs that will deliver a synergistic benefit, and locks the desired ratio in a nano-scale drug delivery vehicle that maintains the ratio in patients with the goal of improving clinical outcomes. The company pipeline includes two Phase 2 products; CPX-351 (a liposomal formulation of cytarabine:daunorubicin) for the treatment of acute myeloid leukemia and CPX-1 (a liposomal formulation of irinotecan:floxuridine) for the treatment of colorectal cancer; a preclinical stage compound, CPX-571 (a liposomal formulation of irinotecan:cisplatin); and multiple research programs, including the hydrophobic docetaxel prodrug nanoparticle (HDPN) formulation being studied by the National Cancer Institute's Nanotechnology Characterization Laboratory. Based on the applications of CombiPlex and the proprietary nanoparticle prodrug delivery platform, Celator is positioned to advance a broad pipeline of cancer therapies involving both previously approved and novel drug agents. For more information, please visit the company's website at www.celatorpharma.com. Information on ongoing trials is available at www.clinicaltrials.gov.
CPX-351 (Cytarabine:Daunorubicin) Liposome Injection represents a new approach to developing combinations of drugs in which drug molar ratios with synergistic anti-tumor activity are encapsulated in a drug delivery vehicle in order to maintain the desired ratio following administration. CPX-351 has been granted orphan drug status by the U.S. Food & Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML). CPX-351 is currently in phase 2 clinical development for the treatment of AML. In addition to the present trial, Celator has completed a randomized phase 2 study comparing CPX-351 to the standard "7+3" regimen of cytarabine:daunorubicin in patients 60 years of age up to and including 75 years of age with newly diagnosed AML. Celator previously announced the primary efficacy endpoint of the study, the rate of patients achieving a complete remission with CPX-351 compared to "7+3," achieved statistical significance. In addition, the Company reported a reduction in the 30-day and 60-day mortality with CPX-351 versus the "7+3" regimen. The primary efficacy endpoint analysis, and additional results from this study, will be presented at the upcoming American Society of Hematology meeting in Orlando, FL.
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