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

Cleveland BioLabs, Inc. 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.