Celator(R) Pharmaceuticals Enrolls First Patient In Its Phase 2 Study Of CPX-351 In Acute Myeloid Leukemia In First Relapse

Main Category: Lymphology/Lymphedema
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 11 Mar 2009 - 1:00 PDT

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Celator Pharmaceuticals announced that the first patient has been treated in its Phase 2 multicenter, randomized, open-label clinical trial of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection versus intensive salvage therapy in adult patients (up to 60 years old) with acute myeloid leukemia in first relapse. As previously announced, the study is being supported through a partnership with The Leukemia & Lymphoma Society (LLS).

The first patient was enrolled by Maureen Cooper, M.D., at St. Francis Hospital in Beech Grove, Indiana. "We are pleased to be participating in this study and eager to collect additional clinical evidence demonstrating the benefit of delivering and maintaining a synergistic ratio of these two widely used drugs for the treatment of AML," said Dr. Cooper.

"CPX-351 represents a unique approach to enhancing the clinical benefit of the two most active drugs used in the treatment of patients with AML," said Jonathan Kolitz, M.D., Director of the Leukemia Service at North Shore University Hospital and lead investigator for the study. "There is no standard of care established for patients in first relapse. We expect that this study will build on the promising results initially obtained in this patient population in the Phase 1 study and provide additional confirmation of the clinical benefit of CPX-351."

The study (Protocol CLTR0308-205) will enroll up to 120 patients between the ages of 18 and 60 who have pathological confirmation of relapsed AML after an initial complete response to prior therapy lasting at least one month. Patients will be 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. Patients will be monitored for all clinical adverse events as well as laboratory evaluations. 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, event-free survival, aplasia rate, and rate of transfer for stem cell transplant. The study will be open for enrollment at leading institutions in the United States and Canada.

"We are delighted that our second Phase 2 study of CPX-351 in AML is underway and appreciate the support of LLS and the enthusiasm of our clinical investigators," said Scott Jackson, chief executive officer of Celator Pharmaceuticals. "There has been increasing excitement in the medical community about CPX-351 and we look forward to developing this product for the benefit of patients with AML."

About CPX-351

CPX-351 represents a new approach to treatment, where synergistic molar ratios of combined drugs are encapsulated in a drug delivery vehicle in order to deliver and maintain the desired ratio following administration. CPX-351 has been granted orphan drug status by the U.S. Food & Drug Administration for the treatment of AML and is also currently being studied in a Phase 2 randomized trial comparing CPX-351 versus conventional cytarabine and daunorubicin therapy ("7+3") in patients 60-75 years of age with untreated AML.

About Acute Myeloid Leukemia

Acute Myeloid Leukemia is defined as a quickly progressing disease in which too many immature white blood cells (not lymphocytes) are found in the blood and bone marrow. In 2008, The Leukemia & Lymphoma Society estimates 13,290 new cases of AML and 8,820 deaths.

About The Leukemia & Lymphoma Society

The Leukemia & Lymphoma Society (R) (LLS) is the world's largest voluntary health agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, Hodgkin's disease and myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world and provides free information and support services.

Founded in 1949 and headquartered in White Plains, NY, LLS has chapters throughout the United States and Canada.

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(R), 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: CPX-351 (a liposomal formulation of cytarabine: daunorubicin), currently in Phase 2 in patients with acute myeloid leukemia; CPX-1 (a liposomal formulation of irinotecan:floxuridine), currently in Phase 2 in patients with colorectal cancer; CPX-571 (a liposomal formulation of irinotecan:cisplatin), a preclinical stage compound; and multiple research programs. Based on the applications of CombiPlex, Celator is positioned to advance a broad pipeline of combination therapies involving both previously approved and novel drug agents. For more information, please visit the company's website at http://www.celatorpharma.com. Information on ongoing trials is available at http://www.clinicaltrials.gov.

Celator Pharmaceuticals
http://www.celatorpharma.com