10 November 2010 – BioInvent International AB (OMXS: BINV) announces IND clearance from the U.S. Food & Drug Administration (FDA) to initiate a Phase II study for BI-204. BI-204 is a human monoclonal antibody that specifically targets oxidized forms of a low-density lipoprotein (LDL) which has been linked to increased inflammatory processes leading to plaque formation in the blood vessel walls. BI-204 is being co-developed with Genentech for secondary prevention of cardiovascular events in patients with acute coronary syndrome (ACS).
The Phase II study is a multicenter, randomized, double-blind, placebo-controlled study of intravenous BI-204 in patients on standard-of-care therapy for stable atherosclerotic cardiovascular disease. Inflammation plays a critical role in the pathogenesis of atherosclerosis. The trial is designed to demonstrate a significant reduction in plaque inflammation following treatment with BI-204 as quantified by FDG-PET (18F 2‑deoxyglucose positron emission tomography). The trial will enrol 120 patients with stable coronary vascular disease in centers in the United States and Canada. The topline results of the study are expected to be reported in the first half of 2012. Additional trials are being contemplated in patients with ACS prior to commencing Phase III....BioInvent's Press Release -
