Combinability of CRLX101 and Avastin® Established in Clinical Trial in Renal Cell Carcinoma Encouraging activity seen in first patient cohort to be confirmed in trial expansion

CAMBRIDGE, Mass., Sept. 26, 2013 /PRNewswire/ -- Cerulean Pharma Inc., a leader in dynamically tumor-targeted nanopharmaceuticals, today announced that the combinability of CRLX101 and Avastin has been established in a Phase 1b/2a clinical trial studying the use of this combination to treat patients with metastatic renal cell carcinoma (mRCC). Patients treated with CRLX101 and Avastin® at their respective MTDs did not require treatment discontinuations or dose reductions. In addition, three out of the first nine patients treated experienced RECIST partial responses following progression on prior lines of therapy, including VEGF inhibitors. This clinical trial, which is being conducted at the University of Pennsylvania Abramson Cancer Center, will now expand to enroll a total of 22 mRCC patients.

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According to the American Cancer Society, about 65,000 new cases of kidney cancer will be diagnosed in the U.S. in 2013, with renal cell carcinoma the most common form of the disease. A genetic mutation frequently identified in tumors associated with renal cell carcinoma leads to high levels of hypoxia-inducible factor-1a (HIF-1a), a protein that helps cancer cells defend themselves against various chemotherapies. HIF-1a is up-regulated in hypoxic conditions created by anti-angiogenic agents such as Avastin, so an effective inhibitor of HIF-1a is expected to improve patient outcomes for many drugs whose mechanism of action is to starve tumors of blood supply. While there is no approved medicine demonstrating effective inhibition of HIF-1a, CRLX101 demonstrates dual inhibition of topoisomerase 1 and HIF-1a, and the results from the first nine patients in this clinical trial suggest that CRLX101's durable inhibition of HIF-1a will translate into clinical benefit for cancer patients.

"We have established that the recommended dose of CRLX101 can be used in combination with the standard RCC dosing of bevacizumab," said the study's principal investigator, Stephen Keefe, M.D., of Penn's Abramson Cancer Center. "We've also observed that patients with both clear cell and non-clear cell disease appear to be deriving clinical benefit, beyond what would have been predicted with a single drug alone." 

Edward Garmey, M.D, chief medical officer of Cerulean, commented: "CRLX101 is designed to concentrate in tumors and release its payload over an extended period of time in order to maximize the drug's effect. That sustained release allows for a durable inhibition of HIF-1a, which could be the reason for the encouraging progression free survival and tumor shrinkages we have seen in a patient population where neither is expected."

About CRLX101
CRLX101 is an investigational anti-cancer agent that inhibits topoisomerase 1 (topo 1) and hypoxia-inducible factor-1a (HIF-1a). Topo 1 is an essential cell replication enzyme and a commercially validated anti-cancer target. HIF-1a is a master regulator of cancer cell survival mechanisms such as cancer stem cell formation and is upregulated under hypoxic conditions created by traditional cancer therapies, for example anti-angiogenic agents and radiation. To date, HIF-1a has been undruggable. 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. CRLX101 has been dosed in more than 200 patients, many for more than six months. Anti-tumor activity (multiple RECIST responses and prolonged stable disease) has been observed in three different tumor types in highly refractory treatment settings, as monotherapy and in combination with Avastin®. 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 held and funded by leading investors, including Polaris Venture Partners, Venrock, Lilly Ventures, Lux Capital, and CVF, LLC. Cerulean is located in Cambridge, Massachusetts. For more information, please visit the Company's website at http://www.ceruleanrx.com.

Media Contact:
Laura Kempke
Schwartz MSL
cerulean@schwartzmsl.com
+1 781-684-0770

SOURCE Cerulean Pharma Inc.



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