WALTHAM, Mass.--(BUSINESS WIRE)--Cerulean Pharma Inc. (NASDAQ:CERU), a clinical-stage company developing nanoparticle-drug conjugates (NDCs), today announced 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. This trial is being conducted by Cerulean in collaboration with the GOG Foundation, Inc.
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.
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.
About Cerulean Pharma
The Cerulean team is committed to improving treatment for people living with cancer. We apply our Dynamic Tumor Targeting™ Platform to create a portfolio of NDCs designed to selectively attack tumor cells, reduce toxicity by sparing the body’s normal cells, and enable therapeutic combinations. Our first platform-generated NDC clinical candidate, CRLX101, is in multiple clinical trials in combination with other cancer treatments, all of which aim to unlock the power of combination therapy. Our second platform-generated NDC clinical candidate, CRLX301, is in a Phase 1/2a clinical trial. For more information, please visit www.ceruleanrx.com.
Cautionary Note on Forward Looking Statements
Any statements in this press release about our future expectations, plans and prospects, including statements about the clinical development of our product candidates, statements about the sufficiency of cash and cash equivalents to fund our operations, debt service and other scheduled expenditures and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and completion of clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for regulatory approvals, availability of funding sufficient for our foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 2, 2016, and in other filings that we make with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent our views only as of the date of this release and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update any forward-looking statements included in this press release.
Avastin is a registered trademark of Genentech, Inc.