Cleveland BioLabs (NASDAQ:CBLI), a biopharmaceutical company, started dosing in a mid-stage 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, the Buffalo, New York-based company said in a statement on Tuesday.
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.
Shares closed down 0.3% at $3.80 on Tuesday. The stock has lost 24% of its market value over the past twelve months.