3/22/2013 7:51:01 AM
CAMBRIDGE, Mass., March 22, 2013 /PRNewswire/ -- Cerulean Pharma Inc. today announced that a randomized Phase 2b study of its experimental cancer treatment, CRLX101, in patients with advanced non-small cell lung cancer (NSCLC) did not meet its primary efficacy endpoint, overall survival benefit. Consistent with earlier clinical trials, CRLX101 showed signals of activity, including tumor reductions that meet RECIST criteria, and a favorable safety profile. CRLX101 is being studied in four other ongoing clinical trials.
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"Late-stage lung cancer is a very difficult disease to treat, and we are disappointed that we did not achieve our ambitious goal of improving survival for patients who have limited treatment options," said Oliver Fetzer, Ph.D., Cerulean President and CEO. "However, we are excited about the ongoing monotherapy and combination therapy clinical studies of CRLX101, and we look forward to the results of these studies."
CRLX101 is being studied in clinical trials in renal cell carcinoma in combination with Avastin®, and as a monotherapy in ovarian cancer, gastric cancer, and small cell lung cancer at leading U.S. academic institutions. Combination data with Avastin will be presented at the American Association of Cancer Research Annual Meeting in April.
Patients in the Phase 2b NSCLC trial had measureable disease, previously progressed through one or two different regimens of chemotherapy, and had evidence of disease progression prior to enrollment. The study enrolled 157 patients in Russia and Ukraine who were randomized in a two-to-one ratio to two treatment arms, CRLX101 plus Best Supportive Care (BSC) compared to BSC alone. The trial's primary endpoints were (i) median overall survival and (ii) safety and tolerability. Study participants were additionally assessed for progression-free survival, objective tumor response, and pharmacokinetic parameters. The company will analyze the data from this trial to inform the further clinical development of CRLX101.
Cerulean would like to extend its thanks to the patients and investigators who participated in this trial and the families of the patients.
CRLX101 is an investigational anti-cancer treatment that is a dual inhibitor of topoisomerase 1 and hypoxia-inducible factor-1. 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 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.
Kim McCrossen or Kristin Villiotte
SOURCE Cerulean Pharma Inc.