US-based Celator Pharmaceuticals has enrolled the first patient in a Phase II pharmacokinetic and pharmacodynamics (PK/PD) study of CPX-351 (cytarabine:daunorubicin) Liposome Injection.
The open-label Phase II study seeks to evaluate the effects of CPX-351 on cardiac repolarisation in adult patients with acute haematologic malignancies, including acute myeloid leukaemia (AML), acute lymphoblastic leukaemia (ALL), and myelodysplastic syndrome (MDS).
Celator Pharmaceuticals CEO Scott Jackson said: "We continue to work expeditiously to bring CPX-351 before the FDA as a potential new treatment option for patients with acute haematologic malignancies.
"The FDA requires clinical pharmacology studies for new drugs in development, so we are pleased to have this Phase II study underway to support our plans for a NDA submission."
The company plans to enrol 36 patients in the study, which is being conducted to support the US Food and Drug Administration (FDA) requirements of a new drug application (NDA) for CPX-351.
In the study, a first induction of CPX-351 will be given to each patient on days one, three and five. A second induction for patients with reduced leukaemia / MDS burden not yet achieving a leukaemia / MDS-free state will be administered only if deemed necessary.
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Patients who are responding to the treatment will be eligible for up to four consolidation courses.
As part of the Phase II study, patients with moderate baseline hepatic and renal impairment will also be recruited to assess the safety and pharmacokinetic observations in this group of patients.
The study will also assess the impact of moderate hepatic impairment on cytarabine and daunorubicin pharmacokinetics as well as evaluate the impact of moderate renal impairment on cytarabine and daunorubicin pharmacokinetics.
Jackson added: "We expect to report top-line results from this study in the second half of 2015."