Phase 2 Study is Designed to Support Potential New Drug Application (NDA) Submission
EWING, NJ, USA I August 19, 2014 I Celator Pharmaceuticals, Inc. (CPXX), a pharmaceutical company developing new and more effective therapies to treat cancer, today announced that the first patient has been enrolled in a Phase 2 pharmacokinetic and pharmacodynamics (PK/PD) study evaluating the effects of CPX-351 (cytarabine:daunorubicin) Liposome Injection on cardiac repolarization in adult patients with acute hematologic malignancies, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS). 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.
“We continue to work expeditiously to bring CPX-351 before the FDA as a potential new treatment option for patients with acute hematologic malignancies,” said Scott Jackson, Chief Executive Officer of Celator Pharmaceuticals. “The FDA requires clinical pharmacology studies for new drugs in development, so we are pleased to have this Phase 2 study underway to support our plans for a NDA submission. We expect to report top-line results from this study in the second half of 2015. “
The open-label, single-arm, Phase 2 study is a thorough PK/PD assessment designed to: (1) measure the effects of CPX-351 on cardiac repolarization following the first induction cycle of CPX-351, (2) assess the impact of moderate hepatic impairment on cytarabine and daunorubicin pharmacokinetics, and (3) 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 necessary, 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.
“Patients with high-risk leukemias are long overdue for an FDA approved anti-leukemic agent that is both safe and effective for high risk leukemias,” said S. Eric Rubenstein, M.D., Medical Director of Cancer Research Services at Franciscan St. Francis Health, who enrolled the first patient. “The majority of patients we encounter in the community have a high-risk form of acute leukemia, so we are eager to work with Celator on their novel therapeutic, CPX-351, which is being studied in this important cohort.”
The Phase 2 study is being conducted to support the U.S. Food and Drug Administration (FDA) requirements of a NDA for CPX-351.
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(R), 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 lead product, CPX-351 (a liposomal formulation of cytarabine:daunorubicin) for the treatment of acute myeloid leukemia; CPX-1 (a liposomal formulation of irinotecan:floxuridine) for the treatment of colorectal cancer; a preclinical stage product candidate; CPX-8 (a hydrophobic docetaxel prodrug nanoparticle formulation) being studied by the National Cancer Institute’s Nanotechnology Characterization Laboratory; and a program exploring novel combinations of existing drugs, including targeted therapies.
SOURCE: Celator Pharmaceuticals
Post Views: 27
Phase 2 Study is Designed to Support Potential New Drug Application (NDA) Submission
EWING, NJ, USA I August 19, 2014 I Celator Pharmaceuticals, Inc. (CPXX), a pharmaceutical company developing new and more effective therapies to treat cancer, today announced that the first patient has been enrolled in a Phase 2 pharmacokinetic and pharmacodynamics (PK/PD) study evaluating the effects of CPX-351 (cytarabine:daunorubicin) Liposome Injection on cardiac repolarization in adult patients with acute hematologic malignancies, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS). 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.
“We continue to work expeditiously to bring CPX-351 before the FDA as a potential new treatment option for patients with acute hematologic malignancies,” said Scott Jackson, Chief Executive Officer of Celator Pharmaceuticals. “The FDA requires clinical pharmacology studies for new drugs in development, so we are pleased to have this Phase 2 study underway to support our plans for a NDA submission. We expect to report top-line results from this study in the second half of 2015. “
The open-label, single-arm, Phase 2 study is a thorough PK/PD assessment designed to: (1) measure the effects of CPX-351 on cardiac repolarization following the first induction cycle of CPX-351, (2) assess the impact of moderate hepatic impairment on cytarabine and daunorubicin pharmacokinetics, and (3) 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 necessary, 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.
“Patients with high-risk leukemias are long overdue for an FDA approved anti-leukemic agent that is both safe and effective for high risk leukemias,” said S. Eric Rubenstein, M.D., Medical Director of Cancer Research Services at Franciscan St. Francis Health, who enrolled the first patient. “The majority of patients we encounter in the community have a high-risk form of acute leukemia, so we are eager to work with Celator on their novel therapeutic, CPX-351, which is being studied in this important cohort.”
The Phase 2 study is being conducted to support the U.S. Food and Drug Administration (FDA) requirements of a NDA for CPX-351.
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(R), 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 lead product, CPX-351 (a liposomal formulation of cytarabine:daunorubicin) for the treatment of acute myeloid leukemia; CPX-1 (a liposomal formulation of irinotecan:floxuridine) for the treatment of colorectal cancer; a preclinical stage product candidate; CPX-8 (a hydrophobic docetaxel prodrug nanoparticle formulation) being studied by the National Cancer Institute’s Nanotechnology Characterization Laboratory; and a program exploring novel combinations of existing drugs, including targeted therapies.
SOURCE: Celator Pharmaceuticals
Post Views: 27
