Celator Pharmaceuticals, Inc. Announces Start of Clinical Study of CPX-351 in Pediatric, Adolescent and Young Adult Patients With Relapsed or Refractory Hematologic Malignancies

EWING, N.J.--(BUSINESS WIRE)--Celator Pharmaceuticals, Inc. (OTCQB:CLPM), a pharmaceutical company developing new and more effective therapies to treat cancer, today announced that the first patient has enrolled in an investigator-initiated clinical study evaluating CPX-351 (cytarabine:daunorubicin) Liposome Injection in pediatric, adolescent and young adult patients with relapsed or refractory hematologic malignancies. This study will be conducted in two phases: a dose exploration phase and an expanded phase. The study will assess the pharmacokinetics, tolerability, as well as early evidence of efficacy of CPX-351 in pediatric, adolescent and young adult patients with relapsed or refractory hematologic malignancies, which includes acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and aggressive lymphoma. Patients will receive a single course of CPX-351 administered on Days 1, 3 and 5. The dose exploration phase, which could enroll 5 to 12 patients, will be used to determine a safe and tolerable dose of CPX-351 in patients between 1 and 21 years of age. After completion of the dose exploration phase of the study, 3 to 18 additional patients between 1 and 30 years of age will be enrolled as part of the expanded phase. The initiation of this study follows data in adult AML patients treated with CPX-351 which suggests high levels of antileukemic activity with acceptable toxicity.

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