Cerulean Pharma Inc., a leader in developing dynamically tumour-targeted nanopharmaceuticals, has dosed its first patient in a phase II study of its lead candidate, CRLX101, in platinum-resistant ovarian cancer patients.

Having completed enrollment of a 150-patient randomized phase II study in advanced non-small cell lung cancer, Cerulean is beginning to capitalize on the breadth of the CRLX101 opportunity by expanding its development into additional tumour types with several studies conducted by leading investigators.  This newly opened trial is designed to evaluate the activity of CRLX101, a nanopharmaceutical that inhibits both topoisomerase 1 and hypoxia-inducible factor-1 alpha, in ovarian cancer patients whose disease has progressed following standard first-line platinum-based therapy.  Current approved second-line therapy for ovarian cancer includes use of the topoisomerase 1 inhibitor, topotecan, which has limitations.  The study is being conducted at the Massachusetts General Hospital and led by principal investigator Carolyn Krasner, MD, in cooperation with the Dana Farber Cancer Institute, Brigham and Women’s Hospital, and Beth Israel Deaconess Medical Centre.

“Not only do women with advanced stage ovarian cancer have limited treatment options, but they also suffer from many disease-related symptoms and treatment-related side effects,” said Dr Krasner. “This study will enable us to evaluate the potential use of CRLX101 as a treatment option for those patients.”

“This trial is intended to build on our current clinical data and determine if CRLX101 can offer ovarian cancer patients a new treatment option,” said Edward Garmey, MD, chief medical officer of Cerulean. “We are excited to partner with Dr. Krasner and to expand the development strategy of CRLX101 in an indication with such high unmet needs.”

CRLX101 is an investigational anti-cancer agent that is a dual inhibitor of topoisomerase 1 and hypoxia-inducible factor-1 alpha. CRLX101 is a dynamically tumour-targeted nanopharmaceutical designed to concentrate in tumors, prolonging drug exposure at the site of action. Significant anti-tumour activity has been observed across a wide range of cancers in animal models. CRLX101 is currently in phase II clinical development.

Cerulean Pharma Inc. is a clinical-stage company specializing in the development of dynamically tumour-targeted nanopharmaceuticals. Cerulean is applying its proprietarynanopharmaceutical platform to advance a new class of therapeutic agents to address significant unmet medical needs.