Cerulean Pharma announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its nanoparticle-drug conjugate (NDC) CRLX101, used in combination with paclitaxel, to treat platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer patients.
“We appreciate the FDA’s acknowledgement of CRLX101’s potential in an area of significant unmet medical need,” Christopher Guiffre, president and chief executive officer of Cerulean, said in a press release. “We are encouraged by the profound treatment effect observed early in the ongoing clinical trial with the GOG Foundation, Inc. (GOG), and we look forward to working closely with the FDA as we endeavor to bring a new treatment option to women living with platinum-resistant ovarian cancer.”
CRLX101 is currently being assessed in an open-label Phase 1b/2 trial (NCT02389985), in combination with weekly paclitaxel, in patients with relapsed ovarian cancer. Results from the Phase 1b part of the study were recently presented at the 2016 Gynecologic Oncology Conference, and demonstrated that five of the first nine patients (56%) treated achieved partial responses, including three who had previously failed on Avastin (bevacizumab) therapy. The trial is being developed in collaboration with the GOG Foundation and Cerulean plans to provide an update of the study at the European Society for Medical Oncology’s 2016 Congress, taking place in Copenhagen in October.
CRLX101 is designed to concentrate in tumors and slowly release its anti-cancer payload, camptothecin, inside tumor cells. Camptothecin, a potent topoisomerase 1 inhibitor, was too toxic to develop clinically, but CRLX101 appears to reduce its toxicity.
CRLX101 has been studied in over 350 patients and has demonstrated clinical activity in multiple tumor types as a monotherapy and in combination with other anti-cancer agents, Cerulean reported in the release. The FDA granted CRLX101 Orphan Drug designation for the treatment of ovarian cancer in 2015; this latest designation is for its combination use in platinum-resistant ovarian cancers, or those that are recurring and resistant to treatment.
If diagnosed prior to metastasis, ovarian cancer has a five-year survival rate of 92 percent. But many patients are found to have metastatic disease at diagnosis and, after initial treatment, face high rates of disease recurrence and limited treatment options.