Celator Pharmaceuticals today announced that the first patient has been treated in its Phase 3, multicenter, randomized, open-label clinical trial of CPX-351 (cytarabine:daunorubicin) Liposome Injection versus conventional cytarabine and daunorubicin therapy (“7+3”) as first-line therapy in patients 60-75 years old with high-risk (secondary) acute myeloid leukemia (AML).
The first patient was enrolled by Stefan K. Barta, M.D., assistant professor of medicine at Montefiore Medical Center of the Albert Einstein College of Medicine. “Having observed how active CPX-351 was in the Phase 2 studies, we are pleased to be able to continue its evaluation and give eligible patients access to this protocol,” said Dr. Barta.
“Clinical studies completed to date suggest that CPX-351 may provide an opportunity to improve outcomes in AML, particularly for high-risk patients whose prognosis on standard therapy is poor,” said Arthur C. Louie, M.D., chief medical officer at Celator Pharmaceuticals. “This Phase 3 study is a critical opportunity to confirm those prior findings.”
The Phase 3 study is being conducted in partnership with The Leukemia & Lymphoma Society® (LLS) which has supported the development of CPX-351, beginning in Phase 2, through its Therapy Acceleration Program (TAP)™.
The study (Protocol NCT01696084) will enroll patients between the ages of 60 and 75 who have pathological diagnosis of AML according to WHO criteria (with at least 20 percent blasts in the peripheral blood or bone marrow) with confirmation of:
AML with a history of myelodysplasia (MDS)
AML with a history of chronic myelomonocytic leukemia (CMMoL)
De novo AML with karyotypic abnormalities characteristic of MDS
Patients will be randomized 1:1 to receive either CPX-351 (100u/m2; Days 1, 3, and 5 by 90 minute infusion) or 7+3 (cytarabine 100mg/m2/day by continuous infusion for 7 days and daunorubicin 60mg/m2 on days 1, 2, and 3). Patients will be monitored for all clinical adverse events as well as laboratory evaluations. The primary efficacy endpoint of the study is overall survival. The study will be conducted in the United States and Canada with approximately 50 leading cancer centers expected to participate.
“The initiation of this study is an important milestone for CPX-351 and for Celator. We hope the data it provides will allow us to seek regulatory approval for CPX-351 and, ultimately, make an important and much-needed treatment option available to patients with AML,” said Scott Jackson, chief executive officer of Celator Pharmaceuticals. “We are grateful for the enthusiastic participation of so many outstanding investigators and institutions, for the strong, ongoing support of LLS, and especially for the patients who will participate.”
CPX-351 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 both the U.S. and the European Union. CPX-351 has completed two randomized, controlled, phase 2 clinical studies for the treatment of acute myeloid leukemia (AML). One study compared CPX-351 to the standard ‘7+3” regimen of cytarabine:daunorubicin in patients 60-75 years of age with newly diagnosed AML and the other compared CPX-351 versus intensive salvage therapy in first relapse AML patients 18-65 years of age. The study in patients with first relapse AML was supported by The Leukemia & Lymphoma Society®, which is also collaborating in the current Phase 3 study.
About Celator Pharmaceuticals, Inc.
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 clinical stage 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 product, 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.