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April 16, 2014
08:12 EDTCBLICleveland BioLabs announces successful completion of Phase 1 study of CBL0102
Cleveland BioLabs announced the achievement of all objectives in a Phase 1 clinical trial of CBL0102, or quinacrine, an orally administered small molecule. The study was performed in patients with advanced cancers for which no standard care exists or which had become resistant to conventional therapies. All patients had tumors involving the liver. CBL0102 is being developed by Incuron, a joint venture between Bioprocess Capital Ventures and Cleveland BioLabs. The primary objective of the study was to evaluate for a maximum tolerated dose and dose-limiting toxicities of CBL0102 in patients with advanced cancers. Secondary objectives were to characterize the drug's safety and to profile its pharmacokinetics. The study also assessed for preliminary evidence of CBL0102 antitumor activity. In particular, the study was designed to explore potential effects related to CBL0102's high relative biodistribution into the liver and therefore included only patients with primary or metastatic liver cancers. Patients were enrolled to receive sequentially higher starting doses of CBL0102 in seven cohorts. Study participants were treated with CBL0102 given orally daily. Patients could continue therapy for eight weeks, or longer if they appeared to be benefiting from therapy.
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February 2, 2016
08:15 EDTCBLICleveland BioLabs initiates colorectal cancer study of entolimod in Russia
Cleveland BioLabs 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-naive 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.
January 29, 2016
16:50 EDTCBLICleveland BioLabs files to sell 6.72M shares of common stock for holders
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January 26, 2016
07:40 EDTCBLICleveland BioLabs announces start of Phase 2 study of CBLB612 in Russia
Cleveland BioLabs 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.

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