Mar 4 2015
Cerulean Pharma Inc., a leader in Dynamic Tumor Targeting™, today announced it has signed a clinical research agreement with the GOG Foundation Inc. to conduct an open-label Phase 1b clinical trial of its lead product candidate, CRLX101, in combination with weekly paclitaxel in patients with relapsed ovarian cancer.
Cerulean and the GOG Foundation have commenced start-up procedures and expect to enroll the first patient in the second quarter of 2015. This trial is being conducted by Cerulean in collaboration with the GOG Foundation under the direction of principal investigator Carolyn N. Krasner, M.D., of the Massachusetts General Hospital Cancer Center.
“Cerulean is expanding the clinical development of CRLX101 in relapsed ovarian cancer by initiating a Phase 1b trial of CRLX101 plus weekly paclitaxel in collaboration with the GOG Foundation,” said Paul Friedman, M.D., Executive Chairman at Cerulean. “We continue to study CRLX101 in combination with Avastin®, and given the changing landscape in relapsed ovarian cancer resulting from the FDA’s recent approval of Avastin in combination with three chemotherapies, we have decided to explore an additional combination with CRLX101 in relapsed ovarian cancer.”
Paclitaxel, a widely used chemotherapy in the treatment of metastatic ovarian cancer, has anti-angiogenic properties which can induce hypoxic conditions, leading to the up-regulation of HIF-1α, causing tumors to develop drug resistance. Preclinical data demonstrate that CRLX101 reduces the up-regulation of HIF-1α, and may sensitize tumors that have become resistant to previous therapy.
This is a Phase 1b multi-center, open-label, dose-escalation study of CRLX101 in combination with weekly paclitaxel in up to 18 patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer. The trial is designed to identify the maximum tolerated dose (MTD) as well as pharmacokinetics, safety and tolerability of CRLX101 in combination with weekly paclitaxel. Preliminary evidence of efficacy will also be evaluated.
Source: http://www.ceruleanrx.com/