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Cerulean Announces CRLX101 Combination Data at 2014 ASCO Annual Meeting

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CHICAGO, June 3, 2014 (GLOBE NEWSWIRE) -- ASCO Annual Meeting: Cerulean Pharma Inc. (Nasdaq:CERU), a leader in Dynamic Tumor Targeting™, announced today that three abstracts on its lead candidate, CRLX101, were included in the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago from May 30 through June 3.

An interim analysis of CRLX101 in combination with Avastin® (bevacizumab) in a Phase 1b/2 clinical trial in patients with relapsed renal cell carcinoma (RCC), which was previously presented by Stephen Keefe, M.D., of the University of Pennsylvania Abramson Cancer Center at the ASCO Genitourinary Cancers Symposium in January, also was included in the ASCO Annual Meeting's electronic compendium of abstracts. This ongoing trial has shown that CRLX101 can be combined safely with Avastin, and preliminary outcomes suggest a clinical benefit in response rate and progression-free survival (PFS). The trial is being conducted at the Abramson Cancer Center and Thomas Jefferson University Hospital.

Carolyn Krasner, M.D., of Massachusetts General Hospital and Harvard Medical School presented final data from a Phase 2 clinical trial evaluating CRLX101 as a monotherapy in patients with relapsed ovarian cancer. This trial met its endpoint, with six patients achieving PFS of more than six months. The trial was completed at hospitals affiliated with Harvard Medical School, and it served as the foundation for a trial currently being conducted at the same hospitals in which CRLX101 is being evaluated in combination with Avastin in platinum-resistant ovarian cancer patients.

Andrew Wang, M.D., of the Lineberger Comprehensive Cancer Center of the University of North Carolina Chapel Hill introduced an ongoing Phase 1b/2 clinical trial of CRLX101 in combination with Xeloda® (capecitabine) and radiotherapy in the neoadjuvant setting for patients with locally advanced rectal cancer. The trial is being conducted at the Lineberger Comprehensive Cancer Center and the Melvin and Bren Simon Cancer Center at Indiana University School of Medicine.

"Collectively, these abstracts demonstrate the potential value of CRLX101 in combination with other cancer treatments across a range of cancers," said Oliver S. Fetzer, Ph.D., President and Chief Executive Officer of Cerulean. "We're working to advance CRLX101 in combination with other cancer treatments in all three indications, and we expect to launch a randomized trial in relapsed RCC this summer."

About CRLX101

CRLX101 is a dynamically tumor-targeted nanopharmaceutical 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 hypoxia-inducible factor-1a (HIF-1a), which research suggests is a master regulator of cancer cell survival mechanisms thought to promote drug and radiation resistance. CRLX101 has shown activity in late-stage disease in three different tumor types, both as monotherapy and in combination with Avastin®. CRLX101 is currently in Phase 2 clinical development and has been dosed in more than 200 patients.

About Cerulean's Dynamic Tumor Targeting Platform

Cerulean's Dynamic Tumor Targeting Platform creates nanopharmaceuticals that are designed to provide safer and more effective cancer treatments. We believe our nanopharmaceuticals concentrate their anti-cancer payloads inside tumors while sparing normal tissue because they are small enough to pass through the "leaky" vasculature present in tumors but are too large to pass through the wall of healthy blood vessels. Once inside tumors, our nanopharmaceuticals enter tumor cells where they slowly release anti-cancer payloads from within the tumor cells.

About Cerulean

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 nanopharmaceuticals designed to selectively attack tumor cells, reduce toxicity by sparing the body's normal cells and enable therapeutic combinations. Our lead product candidate, CRLX101, is in multiple clinical trials with approved cancer treatments with the aim of unlocking the power of combination therapy. 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, and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "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 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 27, 2014 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 trademark of Genentech Inc. Xeloda® is a trademark of Hoffmann-La Roche Inc.

CONTACT: For IR: Heather Savelle MacDougall Biomedical Communications 781.235.3060 hsavelle@macbiocom.com For PR: Laura Kempke MSLGROUP 781.684.0770 laura.kempke@mslgroup.com

Source:Cerulean Pharma Inc.