Cleveland BioLabs Announces Start of Phase 2 Study of CBLB612 in Russian Federation

BUFFALO, NY--(Marketwired - Jan 26, 2016) - Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced the start of dosing in a Phase 2, randomized, placebo-controlled clinical study of CBLB612 as myelosuppressive prophylaxis in patients with breast cancer receiving doxorubicin-cyclophosphamide chemotherapy.

CBLB612 is a synthetic lipopeptide that activates pro-survival and immunoregulatory signaling pathways via specific binding to Toll-like receptors 2 and 6 that are present on a subset of body tissues and cell types that express this receptor.

The study will primarily assess whether CBLB612 will ameliorate the myelosuppressive effects of doxorubicin-cyclophosphamide chemotherapy. Patients with breast cancer will be randomized into one of three arms: to receive placebo given before and after chemotherapy, to receive a single dose of CBLB612 given before chemotherapy, or to receive a single dose of CBL612 given after chemotherapy. The study will evaluate CBLB612 effects on the depth and duration of chemotherapy-induced neutropenia and thrombocytopenia. The trial will also assess changes in the numbers of circulating bone marrow progenitor cells and reticulocytes, the concentrations of plasma cytokines, and CBLB612 safety. At least 39 evaluable patients are expected to be enrolled into the study, which is being conducted at up to six 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, "Based on our previous studies, we believe an opportunity may exist for CBLB612 to offer a single-dose alternative to existing hematopoietic growth factors. This clinical proof-of-concept study will help us evaluate whether CBLB612 can act as a bone marrow protective agent when given before chemotherapy or as a bone marrow restorative agent when given after chemotherapy." 

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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