CRLX101 Advances to Second Stage of Phase 2 Clinical Trial in Advanced Ovarian Cancer

CAMBRIDGE, Mass, Jan. 7, 2013 /PRNewswire/ -- Cerulean Pharma Inc., a leader in designing and developing dynamically tumor-targeted nanopharmaceuticals, today announced that CRLX101 has achieved the pre-defined gating criterion for advancement into stage two of a Phase 2 clinical trial in advanced ovarian cancer.  Ten patients were enrolled in stage one of the trial.  The first of these patients completed six cycles of therapy without cancer progression, triggering advancement into stage two of the trial in which 19 additional patients will be enrolled. 

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CRLX101, an investigational nanopharmaceutical that inhibits both topoisomerase 1 and hypoxia-inducible factor-1α, is being evaluated in a five tumor-type clinical development program, including this Phase 2 clinical trial.  This signal generating study evaluates the activity of CRLX101 in ovarian cancer patients whose disease has progressed following standard first-line platinum-based therapy.  Current approved second-line therapy for ovarian cancer includes the use of the topoisomerase 1 inhibitor, topotecan, which offers limited survival benefit and is compromised by significant toxicity.

The study is being conducted at the Massachusetts General Hospital, Dana Farber Cancer Institute, Brigham and Women's Hospital, and Beth Israel Deaconess Medical Center, and it is led by principal investigator Carolyn Krasner, M.D.  

"Ovarian cancer is the leading cause of death among gynecologic cancers in the United States with over 20,000 new cases diagnosed per year," said Dr. Krasner.  "These women have limited treatment options, and I am encouraged by the results we have observed among the initial 10 patients treated with CRLX101. Four of these 10 women remain on study without disease progression, and the drug has been well-tolerated." 

"The first patient to achieve six cycles of progression free survival had previously progressed through two prior lines of chemotherapy, yet investigators observed a 37 percent net reduction in tumor burden, satisfying the criterion for a RECIST partial response. In addition, investigators observed a 72 percent reduction in circulating levels of CA-125, a key prognostic biomarker for ovarian cancer," said Dr. Edward Garmey, M.D., chief medical officer of Cerulean.  "We are encouraged by these initial results and we are delighted to be working in cooperation with Dr. Krasner and her colleagues at these four institutions."

About CRLX101
CRLX101 is an investigational anti-cancer agent that is a dual inhibitor of topoisomerase 1 and hypoxia-inducible factor-1α.  CRLX101 is a dynamically tumor-targeted nanopharmaceutical designed to concentrate in tumors and release its payload, camptothecin, over an extended period of time, prolonging drug exposure at the site of action.  Significant anti-tumor activity has been observed across a wide range of cancers in animal models and in a Phase 1/2a clinical trial.  CRLX101 is currently in Phase 2 clinical development.  More information on CRLX101 clinical studies can be found at www.clinicaltrials.gov.

About Cerulean Pharma Inc.
Cerulean Pharma Inc. is a clinical-stage company specializing in the development of dynamically tumor-targeted nanopharmaceuticals.  Cerulean is applying its proprietary nanopharmaceutical platform to advance a new class of therapeutic agents to address significant unmet medical needs.  With an initial focus in oncology, the Company's technology platform can be applied to a wide range of drug molecules, ranging from small molecules to peptides and RNAs.  Cerulean is privately financed and funded by experienced healthcare investors, including Polaris Venture Partners, Venrock, Lilly Ventures, Lux Capital, Bessemer Venture Partners, and CVF, LLC.  Cerulean is located in Cambridge, Massachusetts.  For more information, please visit the Company's website at http://www.ceruleanrx.com.

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SOURCE Cerulean Pharma Inc.