On July 19, 2016 Cerulean Pharma Inc. (NASDAQ:CERU), a clinical-stage company developing nanoparticle-drug conjugates (NDCs), reported 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 (Press release, Cerulean Pharma, JUL 19, 2016, View Source [SID:1234513963]). Schedule your 30 min Free 1stOncology Demo! "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."
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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.
The FDA’s Fast Track Program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious conditions and that demonstrate the potential to address unmet medical needs. Drugs that receive this designation benefit from more frequent communications and meetings with FDA to review the drug’s development plan, including the design of the proposed clinical trials and the extent of data needed for approval.
About CRLX101
CRLX101 is a nanoparticle-drug conjugate (NDC) designed to concentrate in tumors and slowly release its anti-cancer payload, camptothecin, inside tumor cells. CRLX101 inhibits topoisomerase 1 (topo 1), which is involved in cellular replication, and also inhibits hypoxia-inducible factor-1α (HIF-1α), which research suggests is a master regulator of cancer cell survival mechanisms. CRLX101 has shown activity in four different tumor types, both as monotherapy and in combination with other cancer treatments. CRLX101 is in Phase 2 clinical development and has been dosed in more than 350 patients. The U.S. FDA has granted CRLX101 Orphan Drug designation for the treatment of ovarian cancer, Fast Track designation in combination with paclitaxel for platinum-resistant ovarian carcinoma, fallopian tube or primary peritoneal cancer, and Fast Track designation in combination with Avastin in metastatic renal cell carcinoma.