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Ovarian Cancer Treatment Shows Promise in Mid-Stage Trial
CRLX101(Cerulean Pharma) has achieved its primary efficacy endpoint in an ongoing open-label, single-arm, phase II monotherapy trial in patients with relapsed ovarian cancer.
The ongoing study is being conducted at Massachusetts General Hospital and the affiliated Harvard teaching hospitals. The trial is investigating the rate of progression-free survival (PFS) at 6 months using RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1 criteria in patients with relapsed ovarian cancer treated with CRLX101.
The study’s primary efficacy endpoint was met when at least four of 29 patients achieved 6 months of PFS. All 29 patients had progressed through one to three lines of cytotoxic chemotherapy before being treated with CRLX101.
CRLX101 is an investigational anticancer agent that inhibits topoisomerase 1 (topo 1) and hypoxia-inducible factor-1a (HIF-1a). Topo 1 is an essential cell-replication enzyme that has been validated as an anticancer 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.
Further, CRLX101 is a tumor-targeted nanopharmaceutical designed to concentrate in tumors and to release its "payload," camptothecin, over an extended period, thereby prolonging drug exposure at the site of action.
Source: Cerulean Pharma; January 13, 2014.