Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The US Food and Drug Administration (FDA) has granted orphan drug designation for Cerulean Pharma's nanoparticle-drug conjugate (NDC), CRLX101, for the treatment of ovarian cancer.
Subscribe to our email newsletter
Currently, the company is exploring two combination treatments for relapsed ovarian cancer.
As part of this advancement, a Phase II trial of CRLX101 plus Avastin is enrolling patients, and a Phase Ib trial of CRLX101 plus weekly paclitaxel in collaboration with the GOG Foundation is expected to start enrolling patients in the second quarter of this year.
CRLX101 is designed to concentrate in tumors and slowly release its anti-cancer payload, camptothecin, inside tumor cells.
In addition to inhibiting topoisomerase 1 (topo 1), which is involved in cellular replication, CRLX101 also inhibits hypoxia-inducible factor-1a (HIF-1a), which research suggests is a master regulator of cancer cell survival mechanisms.
The company said that CRLX101 has demonstrated activity in four different tumor types, both as monotherapy and in combination with other cancer treatments.
Currently, CRLX101 is in Phase II clinical development and has been dosed in more than 250 patients.