Cerulean Announces First Patient Dosed in Phase 2 Pharmacodynamic Study of CRLX101 in Advanced Gastric Cancer

Jan 03, 2013, 11:27 ET from Cerulean Pharma Inc.

CAMBRIDGE, Mass., Jan. 3, 2013 /PRNewswire/ -- Cerulean Pharma Inc., a leader in developing dynamically tumor-targeted nanopharmaceuticals, today announced that the first patient has been dosed in a Phase 2 study of its lead candidate, CRLX101, in patients with advanced gastric cancer.

With the 150-patient randomized Phase 2 study in advanced non-small cell lung cancer expected to read out soon, Cerulean is expanding the clinical development program for CRLX101 to capitalize on the breadth of its therapeutic potential.  This newly opened trial is designed to evaluate the activity of CRLX101, a nanopharmaceutical that inhibits both topoisomerase 1 and hypoxia-inducible factor-1 alpha, in HER-2 negative gastric cancer patients whose disease has progressed following standard frontline therapy.  The study will obtain post-dosing tumor biopsies to determine whether CRLX101 is localized to human gastric tumor tissue.  The study is being conducted at City of Hope Comprehensive Cancer Center and led by principal investigator Yun Yen, M.D., Ph.D.  Mark Davis, Ph.D., an inventor of CRLX101, will also participate in the study.

"Dr. Yen has been a pioneer with CRLX101.  His longtime interest and extensive experience with CRLX101 is invaluable to the development of this drug," said Edward Garmey, M.D., chief medical officer of Cerulean.  "We are fortunate to have another opportunity to collaborate with Drs. Yen and Davis to further elucidate the tumor-targeting mechanism of nanopharmaceuticals and to potentially address the significant unmet medical need in gastric cancer."

"Gastric cancer remains a significant problem worldwide with approximately 650,000 deaths per year," said Dr. Yen, chair of molecular pharmacology at City of Hope.  "Despite promising advances in the continuing development of HER2-targeted therapies, the majority of gastric cancers are HER2 non-overexpressing, so new therapies are needed."

About CRLX101

CRLX101 is an investigational anti-cancer agent that is a dual inhibitor of topoisomerase 1 and hypoxia-inducible factor-1 alpha.  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.