Jul 22 2015
Cerulean Pharma Inc. today announced that the first patient has been dosed in an open label Phase 1b clinical trial of its lead product candidate, CRLX101, in combination with weekly paclitaxel in patients with relapsed ovarian cancer by the University of Virginia School of Medicine. 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.
“Relapsed ovarian cancer is an area of high unmet medical need,” said Chris Guiffre, Cerulean’s President & Chief Executive Officer. “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, a widely used chemotherapy used as subsequent therapy for the treatment of advanced ovarian cancer, has anti-angiogenic properties which can induce hypoxic conditions, leading to the up-regulation of hypoxia inducible factor 1α, or 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 Phase 1b multi-center, open-label, dose-escalation study 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. Preliminary evidence of efficacy will also be evaluated.
Source: http://www.ceruleanrx.com/