Sep 16 2014
Celator Pharmaceuticals, Inc., a pharmaceutical company developing new and more effective therapies to treat cancer, today announced the publication of preclinical data in Pediatric Blood & Cancer that further characterize the therapeutic potential of lead compound CPX-351 in hematological malignancies and support its ongoing clinical testing in pediatric patients with ALL. CPX-351 is currently being studied in a pivotal Phase 3 clinical trial in older patients with high risk (secondary) AML.
"Cytarabine and anthracyclines such as daunorubicin are commonly used to treat ALL in pediatric patients, and while these drug are very effective in front-line multidrug combination chemotherapy regimens, there remains room for improvement, especially in pediatric patients who relapse within 36 months of diagnosis," said Professor Richard Lock, Head of the Leukemia Biology Program at Children's Cancer Institute, Sydney Australia, and senior author on the paper. "We are very encouraged by these preclinical results, indicating that the proprietary CPX-351 formulation of cytarabine and daunorubicin may be an important tool to maximize efficacy outcomes in relapsed ALL, and we believe these data substantiate the need for additional, clinical study in pediatric patients."
The publication titled, "Efficacy of CPX-351, (Cytarabine:Daunorubicin) Liposome Injection, Against Acute Lymphoblastic Leukemia Xenograft Models of the Pediatric Preclinical Testing Program," appeared in the peer-reviewed medical journal, Pediatric Blood & Cancer [doi: 10.1002/pbc.25133, http://onlinelibrary.wiley.com/doi/10.1002/pbc.25133/abstract].
The efficacy of CPX-351 was studied against a panel of aggressive and chemoresistant childhood ALL xenograft models developed at the Children's Cancer Institute as part of the United States National Cancer Institute-funded Pediatric Preclinical Testing Program. The results show that CPX-351 administered at 5 units/kg demonstrated potent anti-leukemic activity in vivo and was highly efficacious against all xenograft models tested, inducing complete responses in four B-lineage xenografts and a partial response in one T-lineage xenograft. The dose used provided clinically relevant plasma drug exposure and correlated to the pharmacokinetic properties observed in patients with AML.
"We are very pleased with these study results and believe they support our decision to evaluate CPX-351 in additional hematological malignancies beyond secondary AML," commented Dr. Lawrence Mayer, President, Founder and Chief Scientific Officer of Celator Pharmaceuticals. "CPX-351 has demonstrated broad activity across a variety of cancers and in high-risk patient populations, and we hope to continue to evaluate its potential in childhood leukemias, where the prognosis is still poor in certain patient subsets."