Celator Pharma Says First Patient Enrolled In Phase 2 CPX-351 Study

(RTTNews) - Celator Pharma says first patient enrolled in Phase 2 CPX-351 study

Celator Pharmaceuticals, Inc. (CPXX), a pharmaceutical company developing new and more effective therapies to treat cancer, Tuesday said the first patient has been enrolled in a Phase 2 pharmacokinetic and pharmacodynamics or PK/PD study evaluating the effects of CPX-351 Liposome Injection on cardiac repolarization in adult patients with acute hematologic malignancies, including acute myeloid leukemia, acute lymphoblastic leukemia and myelodysplastic syndrome.

This study will also include patients with moderate baseline hepatic and renal impairment, extending the range of safety and pharmacokinetic observations to this important group of patients.

The open-label, single-arm, Phase 2 study is a thorough PK/PD assessment designed to measure the effects of CPX-351 on cardiac repolarization following the first induction cycle of CPX-351, and to assess the impact of moderate hepatic impairment on cytarabine and daunorubicin pharmacokinetics.

The study also intends to assess the impact of moderate renal impairment on cytarabine and daunorubicin pharmacokinetics.

The study is expected to enroll 36 patients. Each patient will receive a first induction of CPX-351 on days 1, 3 and 5 and, if needed, a second induction for patients with reduced leukemia/MDS burden not yet achieving a leukemia/MDS-free state.

Responding patients are eligible for up to four consolidation courses.

Analysis of treatment impact on cardiac electrophysiology, as measured by the QTc interval, and PK assessments will be performed only following the first induction course.

The Phase 2 study is being conducted to support the U.S. Food and Drug Administration requirements of a NDA for CPX-351.