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news.US-based Cerulean Pharma has dosed first patient in an open label Phase Ib clinical trial of CRLX101, a nanoparticle-drug conjugate (NDC), in combination with weekly paclitaxel to treat relapsed ovarian cancer.
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Dosing in this multi-center, open-label, dose-escalation trial has been carried out by the University of Virginia School of Medicine.
The company is conducting the trial in collaboration with the GOG Foundation under the direction of principal investigator, Carolyn Krasner of the Massachusetts General Hospital Cancer Center.
Cerulean president and chief executive officer Chris Guiffre said: "We believe that CRLX101 can help women living with ovarian cancer, especially when used in combinations with other cancer treatments.
"We are currently studying CRLX101 in combination with Avastin in another trial of women with relapsed ovarian cancer, and now we have begun studying CRLX101 in combination with weekly paclitaxel in the same setting. We appreciate our collaboration with the GOG Foundation on this important new study."
Paclitaxel has anti-angiogenic properties which can induce hypoxic conditions, leading to the up-regulation of hypoxia inducible factor 1a, or HIF-1a, causing tumors to develop drug resistance.
According to preclinical data, CRLX101 reduces the up-regulation of HIF-1a, and may sensitize tumors that have become resistant to previous therapy.
The Phase Ib trial combines CRLX101 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 as well as pharmacokinetics, safety and tolerability of CRLX101 in combination with weekly paclitaxel in addition to evaluating preliminary evidence of efficacy.