EWING, NJ, USA I September 19, 2013 I Celator Pharmaceuticals Inc. (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.
“The experience in adults has been encouraging,” said Michael Absalon, MD, PhD, Assistant Professor, Division of Hematology/Oncology at Cincinnati Children’s Hospital Medical Center. “The purpose of the clinical trial is to evaluate whether CPX-351 may ultimately be an effective and less toxic alternative to conventional approaches used in the treatment of children and young adults with hematologic malignancies.”
“We are excited to be working with Cincinnati Children’s Hospital in evaluating the potential benefit of CPX-351 in younger patients with hematologic malignancies,” said Scott Jackson, chief executive officer of Celator Pharmaceuticals. “This study reflects our commitment to working with investigators to evaluate CPX-351 in other patient populations with unmet medical need.”
About Celator Pharmaceuticals, Inc.
Celator Pharmaceuticals, Inc., with locations in Ewing, N.J., and Vancouver, B.C., is a pharmaceutical company developing new and more effective therapies to treat cancer. CombiPlex®, 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 two clinical stage products, CPX-351 (a liposomal formulation of cytarabine:daunorubicin) for the treatment of acute myeloid leukemia and CPX-1 (a liposomal formulation of irinotecan:floxuridine) for the treatment of colorectal cancer; and preclinical stage product candidates, including CPX-571 (a liposomal formulation of irinotecan:cisplatin), and the hydrophobic docetaxel prodrug nanoparticle (HDPN) formulation being studied by the National Cancer Institute’s Nanotechnology Characterization Laboratory. For more information, please visit the company’s website at www.celatorpharma.com. Information on ongoing trials is available at www.clinicaltrials.gov.
SOURCE: Celator Pharmaceuticals
Post Views: 127
EWING, NJ, USA I September 19, 2013 I Celator Pharmaceuticals Inc. (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.
“The experience in adults has been encouraging,” said Michael Absalon, MD, PhD, Assistant Professor, Division of Hematology/Oncology at Cincinnati Children’s Hospital Medical Center. “The purpose of the clinical trial is to evaluate whether CPX-351 may ultimately be an effective and less toxic alternative to conventional approaches used in the treatment of children and young adults with hematologic malignancies.”
“We are excited to be working with Cincinnati Children’s Hospital in evaluating the potential benefit of CPX-351 in younger patients with hematologic malignancies,” said Scott Jackson, chief executive officer of Celator Pharmaceuticals. “This study reflects our commitment to working with investigators to evaluate CPX-351 in other patient populations with unmet medical need.”
About Celator Pharmaceuticals, Inc.
Celator Pharmaceuticals, Inc., with locations in Ewing, N.J., and Vancouver, B.C., is a pharmaceutical company developing new and more effective therapies to treat cancer. CombiPlex®, 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 two clinical stage products, CPX-351 (a liposomal formulation of cytarabine:daunorubicin) for the treatment of acute myeloid leukemia and CPX-1 (a liposomal formulation of irinotecan:floxuridine) for the treatment of colorectal cancer; and preclinical stage product candidates, including CPX-571 (a liposomal formulation of irinotecan:cisplatin), and the hydrophobic docetaxel prodrug nanoparticle (HDPN) formulation being studied by the National Cancer Institute’s Nanotechnology Characterization Laboratory. For more information, please visit the company’s website at www.celatorpharma.com. Information on ongoing trials is available at www.clinicaltrials.gov.
SOURCE: Celator Pharmaceuticals
Post Views: 127
