Cleveland BioLabs Announces Start of Colorectal Cancer Study of Entolimod in Russian Federation

BUFFALO, NY--(Marketwired - Feb 2, 2016) - Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced the initiation of a Phase 2, single-blind, randomized, placebo-controlled clinical study of the safety and tolerability of entolimod as a neo-adjuvant therapy in treatment-naïve patients with primary colorectal cancer who are recommended for surgery. 

The primary objective of the study is to determine the optimal dose and dosing regimen for treatment of these patients with entolimod prior to surgery. Secondary objectives include evaluation of pharmacodynamic parameters, including immune response to single or double administrations of entolimod at varying dose levels. Up to 32 patients are expected to be enrolled in the study, which is being conducted at four leading oncology centers in the Russian Federation. The study is supported by a development contract with the Russian Federation Ministry of Industry and Trade.

Langdon Miller, M.D., President and Chief Medical Officer of CBLI, commented, "Preclinical evidence of entolimod's ability to suppress growth of tumors in the liver through mobilization and activation of innate and adaptive immune mechanisms supports investigation of its use in this clinical setting, since the liver is a common site of colorectal cancer tumor metastasis. Our goal is to accumulate additional clinical data regarding immune cell response to administrations of entolimod in order to guide future oncology development."

About Cleveland BioLabs, Inc.
Cleveland BioLabs, Inc. is an innovative biopharmaceutical company developing novel approaches to activate the immune system and address serious medical needs. The company's proprietary platform of Toll-like immune receptor activators has applications in radiation mitigation, oncology immunotherapy, and vaccines. The company's most advanced product candidate is entolimod, which is being developed for a biodefense indication and as an immunotherapy for oncology and other indications. The company conducts business in the United States and in the Russian Federation through a wholly-owned subsidiary, BioLab 612, LLC and a joint venture with OJSC Rusnano, Panacela Labs, Inc. The company maintains strategic relationships with the Cleveland Clinic and Roswell Park Cancer Institute. To learn more about Cleveland BioLabs, Inc., please visit the company's website at http://www.cbiolabs.com.

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