CPX-351 and Acute Myeloid Leukemia
CPX-351 (Cytarabine:Daunorubicin) Liposome Injection
CPX-351 Liposome Injection is a liposomal formulation of a synergistic 5:1 molar ratio of cytarabine and daunorubicin, two agents commonly used to treat hematologic malignancies, particularly acute myeloid leukemia (AML). Research at Celator has shown that cytarabine:daunorubicin administered in a 5:1 ratio delivers a synergistic benefit. Further research has shown that this combination of chemotherapeutic drugs delivered in other ratios can be antagonistic.
CPX-351 has been granted orphan drug status by the U.S. Food & Drug Administration for the treatment of AML.
Ongoing Clinical Trials
Completed Clinical Trials
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 is a liposomal formulation of cytarabine:daunorubicin locked in a synergistic 5:1 molar ratio. CPX-351 is administered intravenously as a 90 minute infusion on Days 1, 3 and 5.
The use of cytarabine in combination with an anthracycline (such as daunorubicin) is the standard of care for the treatment of patients diagnosed with AML. This combination may offer a benefit in patients with other hematologic malignancies, such as acute lymphocytic leukemia.
A Phase 1 dose escalation study in 48 patients with advanced leukemia (45 patients with AML and 3 patients with ALL) has been completed with CPX-351. Data from this study was presented at the 2008 American Society of Hematology meeting. Based on the safety and efficacy seen in the Phase 1 study, Celator has initiated two randomized Phase 2 studies.
Below is an illustration of in vivo activity of CPX-351. This compares an uncontrolled drug ratio of cytarabine and daunorubicin to a locked CPX-351 formulation and also to saline. In this example, the drug ratio maintained by CPX-351 was shown to be considerably more effective than the uncontrolled drug cocktail.
NOTE: 1 unit of CPX-351 is 1 mg cytarabine and 0.44mg of daunorubicin.
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® estimated 13,290 new cases of AML and 8,820 deaths.
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