Recruitment of Patients Completed in Phase II Study with BI-204.
LUND, Sweden -- BioInvent International AB (OMXS: BINV) and its collaborator Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that all patients have completed enrollment in the GLACIER study, a phase IIa study with BI-204 in patients with stable atherosclerotic vascular disease. BioInvent expects to publicly release top-line data from the study in Q3 2012.
Svein Mathisen, President and CEO of BioInvent, said: "We and our partner, Genentech, are eagerly awaiting the results from the GLACIER study. By applying the latest innovation in imaging technology we hope to show that BI-204 is bringing the treatment of atherosclerosis and acute coronary syndromes one step forward, addressing the disease at its root, atherosclerotic plaque inflammation".
BI-204 is a monoclonal antibody targeting oxidised forms of LDL (Low-Density Lipoprotein) cholesterol, also known as "bad cholesterol." Its unique mode-of-action is believed to inhibit pro-inflammatory macrophages at the site of the atherosclerotic plaque, reducing inflammation and stabilizing plaque tissue prone to rupture and cause coronary artery disease.
- END -
To the editors:
GLACIER is the acronym for 'Goal of oxidised Ldl and ACtivated macrophage Inhibition by Exposure to a Recombinant antibody'. It is a randomized, placebo controlled, double-blind, multicentre phase IIa study, where BI-204 is delivered intravenously to patients with stable coronary artery disease on top of standard-of-care. The study involves approximately 144 patients and is being conducted at some 20 centres in the United States and Canada. It is designed to demonstrate a reduction in inflammation at the site of the inflamed atherosclerotic plaque as quantified by FDG-PET imaging (18Fluoro-2-deoxyglucose positron emission tomography) at weeks 4 and 12 following initiation of treatment with BI-204. Coronary inflammation is regarded as the underlying cause of the development of atherosclerosis and coronary artery disease (Ross).
The product candidate BI-204 (anti-oxLDL, MLDL1278A, RG7418) is being developed in collaboration with Genentech, a member of the Roche Group. Genentech holds the rights to North America while BioInvent retains the rights to all other territories. BI-204 is being developed for secondary prevention of cardiovascular events, such as myocardial infarctions, in patients with acute coronary syndromes. The antibody targets oxidized forms of LDL, the "bad" form of cholesterol (Schiopu, Goncalves). Higher concentrations of oxLDL have been shown to correlate strongly with multiple risk factors for adverse cardiovascular events in population studies, including a correlation with insulin resistance and metabolic syndrome (Holvoet). These observations support the idea that oxidized LDL may also be an important target structure for developing new medications to treat patients at elevated risk for experiencing adverse cardiovascular events.
BioInvent International AB, listed on the NASDAQ OMX Stockholm (BINV), is a research-based pharmaceutical company that focuses on developing antibody drugs. The Company currently has four clinical development projects within the areas of thrombosis, cancer and atherosclerosis. The Company has signed various strategic alliances to strengthen the product pipeline and increase the likelihood of success. These partners include Genentech, Human Genome Sciences, Roche and ThromboGenics.
The company's competitive position is underpinned by an in substance patented antibody development platform. The scope and strength of this platform is also utilised by partners, such as Bayer HealthCare, Daiichi Sankyo, Mitsubishi Tanabe and Servier. More information is available at www.bioinvent.com.
Ross R, Atherosclerosis - an inflammatory disease. N Engl J Med 1999
Schiopu A et al, Recombinant antibodies to an oxidized low-density lipoprotein epitope induce rapid regression of atherosclerosis in apobec-1-/-/low-density lipoprotein receptor-/- mice. J Am Coll Cardiol 2007
Goncalves I et al, Identification of the target for therapeutic recombinant anti-apoB-100 peptide antibodies in human atherosclerotic lesions. Atherosclerosis 2009
Holvoet P et al. Association between circulating oxidized low-density lipoprotein and incidence of the metabolic syndrome. JAMA 2008
The press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as the date they are made and are, by their very nature, in the same was as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release.
Information disclosed in this press release is provided herein pursuant to the Swedish Securities Markets Act and/or the Swedish Financial Instruments Trading Act. The information was submitted for publication at 8.30 a.m. CET, on 2 March, 2012..
|Printer friendly Cite/link Email Feedback|
|Comment:||Recruitment of Patients Completed in Phase II Study with BI-204.|
|Date:||Mar 2, 2012|
|Previous Article:||Sara Lee Subsidiary DE International Holdings Files Registration Statement To Begin Spin-Off Process.|
|Next Article:||Research and Markets: Sri Lanka - Internet Services, the Broadband Market and Forecasts - 2011 Year End Report.|