Cerulean commences dosing in CRLX101 Phase 2 study for ovarian cancer

Cerulean Pharma Inc., a leader in developing dynamically tumor-targeted nanopharmaceuticals, today announced that the first patient has been dosed in a Phase 2 study of its lead candidate, CRLX101, in platinum-resistant ovarian cancer patients.

Having completed enrollment of a 150-patient randomized Phase 2 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 tumor 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, M.D., in cooperation with the Dana Farber Cancer Institute, Brigham and Women's Hospital, and Beth Israel Deaconess Medical Center.  

"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, M.D., 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."