Cerulean Pharma Inc., a leader in dynamically tumor-targeted nanopharmaceuticals, today announced that CRLX101 has achieved its primary efficacy endpoint in an ongoing single-arm Phase 2 monotherapy clinical trial in relapsed ovarian cancer.
The ongoing open label Phase 2 monotherapy trial is being conducted at Massachusetts General Hospital and the affiliated Harvard teaching hospitals under the direction of principal investigator, Carolyn Krasner, M.D. The trial investigates the rate of progression free survival at six months using RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1 criteria in relapsed ovarian cancer patients treated with CRLX101. The primary efficacy endpoint for the trial was met when at least four of 29 patients achieved six months of progression-free survival (PFS). All 29 patients had progressed through between one and three prior lines of cytotoxic chemotherapy before being treated with CRLX101. Adverse events observed to date generally have been low grade and manageable.
"We are pleased to have met our primary efficacy endpoint for the trial," said Dr. Krasner, adding that "four patients are still being treated on trial, and we expect to present final data from this trial at ASCO 2014."
CRLX101 is an investigational anti-cancer agent that inhibits topoisomerase 1 (topo 1) and hypoxia-inducible factor-1a (HIF-1a). Topo 1 is an essential cell replication enzyme and a commercially validated anti-cancer target. HIF-1a is a master regulator of cancer cell survival mechanisms such as cancer stem cell formation and is upregulated under hypoxic conditions created by traditional cancer therapies, for example anti-angiogenic agents and radiation. To date, HIF-1a has been undruggable. CRLX101 is a dynamically tumor-targeted nanopharmaceutical designed to concentrate in tumors and release its payload, camptothecin, over an extended period of time, prolonging drug exposure at the site of action. CRLX101 has been dosed in more than 200 patients, many for more than six months. Anti-tumor activity (multiple RECIST responses and prolonged stable disease) has been observed in three different tumor types in highly refractory treatment settings, as monotherapy and in combination with Avastin®. CRLX101 is currently in Phase 2 clinical development. More information on CRLX101 clinical trials can be found at www.clinicaltrials.gov.
About Cerulean Pharma Inc.
Cerulean Pharma Inc. is a clinical-stage company specializing in the development of dynamically tumor-targeted nanopharmaceuticals. Cerulean is applying its proprietary nanopharmaceutical platform to advance a new class of therapeutic agents to address significant unmet medical needs. With an initial focus in oncology, the Company's technology platform can be applied to a wide range of drug molecules, ranging from small molecules to peptides and RNAs. Cerulean is privately held and located in Cambridge, Massachusetts. For more information, please visit the Company's website at http://www.ceruleanrx.com.