Cerulean Pharma announced that CRLX101 has met its primary efficacy endpoint in a Phase 2 monotherapy clinical trial in relapsed ovarian cancer. CRLX101 is an investigational anti-cancer agent that inhibits topoisomerase 1 (topo 1) and hypoxia-inducible factor-1a (HIF-1a) and is designed to concentrate in tumors and release its payload, camptothecin, over an extended period of time, thus prolonging drug exposure at the site of action.
The ongoing open label, single-arm trial is investigating the rate of progression free survival (PFS) 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 endpoint was met when at least four of the 29 patients achieved six months of PFS. All 29 patients had progressed through between one and three prior lines of cytotoxic chemotherapy before being treated with CRLX101.
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