Cleveland BioLabs Announces Results of Phase 1 Study of CBLB612 in Russian Federation

BUFFALO, NY--(Marketwired - Jul 13, 2015) -  Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced the results of a Phase 1 single-blinded, randomized, placebo-controlled, healthy-subject study of CBLB612, an investigational drug in development for oncology indications, including the prevention of chemotherapy-induced myelosuppression. 

The objectives of the study were to evaluate the safety profile of CBLB612, establish the maximum tolerated dose (MTD), assess the drug's pharmacokinetics, and characterize the magnitude and timing of CBLB612 effects on several biomarkers of activity including circulating absolute neutrophil counts (ANC) and concentrations of plasma cytokines (granulocyte colony-stimulating factor [G-CSF], interleukin [IL]-6 IL-8, IL-10 and interferon-alfa [IFN-a]).

Analysis of data from the 56 healthy volunteers enrolled in the study indicates that single subcutaneous injections of CBLB612 in doses ranging from 0.5 to 4 micrograms were generally well-tolerated, with the 4 microgram dose identified as the MTD. Observed adverse events were typically mild or moderate in severity, transient, and related to the drug's mechanism of action. Single injections of CBLB612 induced dose-dependent increases in ANC lasting approximately 20 hours. Administrations of CBLB612 also resulted in rapid, dose-dependent increases of plasma levels of the specified cytokines. Cytokine levels returned to baseline levels several hours after administration of the drug.

Langdon L. Miller, M.D., President and Chief Medical Officer of CBLI, commented, "This first-in-human study in healthy subjects confirmed the expected pharmacological profile of CBLB612. We believe these findings support Phase 2 evaluation of CBLB612 in a clinical model of chemotherapy-induced myelosuppression and are currently planning that study."

The completed Phase 1 trial and planned Phase 2 study are supported by a contract from the Ministry of Industry and Trade of the Russian Federation.

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.

This press release contains certain forward-looking information about Cleveland BioLabs that is intended to be covered by the safe harbor for "forward-looking statements" provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. Words and phrases such as "believe," expected," and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding the conduct and results of our various clinical trials; the efficacy of our therapeutic products; our ability to successfully complete planned clinical studies; and our ability to obtain regulatory approval for our therapeutic products. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. 

These risks and uncertainties include, among others, the risks inherent in the early stages of drug development and in conducting clinical trials; the Company's collaborative relationships and the financial risks related thereto; the Company's ability to comply with its obligations under license agreements; subsequent changes in the agreement with the Russian Ministry of Industry and Trade; and the Company's inability to obtain regulatory approval in a timely manner or at all. Some of these factors could cause future results to materially differ from the recent results or those projected in forward-looking statements. See also the "Risk Factors" and "Forward-Looking Statements" described in the Company's periodic filings with the Securities and Exchange Commission.