On May 19, 2016 Cerulean Pharma Inc. (NASDAQ:CERU), a clinical-stage company developing nanoparticle-drug conjugates (NDCs), reported that the Company will present in an oral session Phase 1b results of an ongoing clinical trial of CRLX101 in combination with weekly paclitaxel in patients with relapsed ovarian cancer at the Gynecologic Oncology 2016 Conference being held May 19-21 in San Antonio, Texas (Press release, Cerulean Pharma, MAY 19, 2016, View Source [SID:1234512613]). This trial is being conducted by Cerulean in collaboration with the GOG Foundation, Inc.
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Details of the presentation are as follows:
Title: A Phase 1b study of the nanoparticle-drug conjugate (NDC) CRLX101 in combination with weekly paclitaxel in patients with advanced neoplasms including platinum-resistant tumors
Date/Time: Thursday, May 19, 2016, 12:20-12:50 pm CDT
Location: Hilton San Antonio Airport Hotel
Summary: As previously announced, a maximum tolerated dose and a recommended Phase 2 dose of 15 mg/m2 for CRLX101 (bi-weekly) and weekly paclitaxel 80 mg/m2 (3 weeks on; 1 week off) have been declared. Three patients were treated with 12 mg/m2 of CRLX101 and six patients were treated with 15 mg/m2 of CRLX101. The combination appears to be generally well tolerated, and no dose limiting toxicities observed at either dose level. To date, the only treatment-related adverse events were one Grade 3 and one Grade 4 neutropenia. The most common adverse events ( > 30%) were fatigue, neutropenia, and nausea. Objective RECIST responses were achieved by 5 of 9 patients (56%), including one patient who experienced complete disappearance of the tumor but had detectable CA125. Importantly, 3 of the 5 patients who achieved objective RECIST responses were previously treated with Avastin (bevacizumab). Based on the antitumor effect observed in these first nine patients, the trial will be expanded.
About GOG Foundation, Inc. (GOG Foundation)
The GOG Foundation, Inc. (GOG Foundation) is an independent international non-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies. The GOG Foundation is committed to maintaining the highest standards in clinical trials development, execution, analysis and distribution of results. Continuous evaluation of the GOG Foundation’s processes is utilized in order to constantly improve the quality of patient care. The GOG Foundation conducts clinical trials for patients with a variety of gynecologic malignancies, including cancers that arise from the ovaries, uterus, cervix, vagina, and vulva. The GOG Foundation is a separate entity from the National Clinical Trials Network groups that are funded by the National Cancer Institute.
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 and Fast Track designation in combination with Avastin in metastatic renal cell carcinoma.