Cerulean Pharma, a clinical-stage company developing nanoparticle-drug conjugates (NDCs), announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for Cerulean's lead nanoparticle-drug conjugate, CRLX101, in combination with paclitaxel, for the treatment of platinum-resistant ovarian carcinoma, fallopian tube or primary peritoneal cancer.
"We appreciate the FDA's acknowledgement of CRLX101's potential in an area of significant unmet medical need," said Christopher D. T. Guiffre, President and Chief Executive Officer of Cerulean. "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 being evaluated in combination with weekly paclitaxel for the treatment of recurrent platinum-resistant ovarian carcinoma in a Phase 1b/2 clinical trial. Data from the Phase 1b portion of the trial were the subject of an oral presentation at the Gynecologic Oncology 2016 Conference in May. These data showed that five of the first nine patients (56%) enrolled in the trial achieved partial responses. Of note, five of the nine patients enrolled in the Phase 1b trial previously failed Avastin® (bevacizumab) and three of these five patients achieved partial responses. Cerulean is conducting this trial in collaboration with the GOG and expects to provide an update at the European Society for Medical Oncology 2016 Congress.
In 2015, CRLX101 was granted Orphan Drug designation for the treatment of ovarian cancer.
