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Cerulean, GOG to conduct Phase Ib trial of CRLX101 combination to treat ovarian cancer

US-based Cerulean Pharma has entered into a clinical research agreement with the GOG Foundation to conduct an open-label Phase Ib clinical trial of its lead product candidate, CRLX101, in combination with weekly paclitaxel to treat patients with relapsed ovarian cancer.

Start-up procedures have already been started and patient enrolment is expected to be initiated in the second quarter of 2015.

Both the parties will jointly conduct the trial under the direction of principal investigator Carolyn Krasner of the Massachusetts General Hospital Cancer Center.

The multi-center, open-label, dose-escalation Phase Ib trial will evaluate 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 will evaluate the preliminary evidence of efficacy as well as identify the maximum tolerated dose (MTD) as well as pharmacokinetics, safety and tolerability of CRLX101 in combination with weekly paclitaxel.

Cerulean executive chairman Paul Friedman said: "Cerulean is expanding the clinical development of CRLX101 in relapsed ovarian cancer by initiating a Phase Ib trial of CRLX101 plus weekly paclitaxel in collaboration with the GOG Foundation.

"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."

The widely used chemotherapy, paclitaxel has anti-angiogenic properties which can induce hypoxic conditions, leading to the up-regulation of HIF-1a, causing tumors to develop drug resistance.

In preclinical trials, CRLX101 has shown to have reduced the up-regulation of HIF-1a, and may sensitize tumors that have become resistant to previous therapy.