US-based life sciences company Global Genomics Group (G3) has completed enrolment of the 5,000-patient discovery group of its GLOBAL (Genetic LOci and Burden of Atherosclerotic Lesions) clinical trial, designed to identify disease-related pathways, new drug targets and biomarkers for cardiovascular diseases.
GLOBAL is a pan-omic trial combining genomics, epigenomics, transcriptomics, proteomics, metabolomics, lipidomics and lipoprotein proteomics with coronary computed tomographic (CT) angiography.
Out of the 5,000 patients enrolled in the discovery group, 2,500 patients are in the control group and the remaining 2,500 are in the case group.
G3 co-founder and vice president of clinical affairs Bradley Brown: "This is an important milestone for G3, as well as for our collaborating researchers and participating patients.
"The GLOBAL study will allow us to gain important insights about the development of cardiovascular disease and to identify new disease biomarkers and therapeutic targets. We anticipate that the pilot data set will be available later this year."
The enrolled patients are being treated at 48 institutions in nine countries and across three continents.
The investigators expect to enroll an additional 2,000 patients in the validation group, with about 1,000 patients in the disease group and 1,000 in the control group.
Midwest Heart & Vascular Specialists principal investigator of the study Stephen Bloom said: "The GLOBAL study is the most ambitious study ever undertaken to investigate the root cause of this complex disease and may not only provide us with new biomarkers and drug targets, but it will also provide us with a platform for early screening, continued monitoring of risk, prevention and early intervention."
The ongoing international, prospective, multi-centre GLOBAL trial is recruiting about 10,000 patients to characterise new disease networks and biomarkers for coronary artery disease (CAD).
G3 expects to release pilot data for the first group of patients later in 2014.
The trial is being funded by G3 and conducted together with strategic partner, Health Diagnostic Laboratory.
The company said that eligible patients undergo coronary CT angiography providing an accurate and detailed examination of the disease and disease status.
Precision phenotyping is combined with a pan-omic analysis, and data is then analysed using specifically-developed systems biology-based bioinformatics technology for identification of diagnostic biomarkers and potential therapeutic targets.
CT is an advanced, non-invasive imaging technology for phenotyping, which allows the precise classification of disease in patients.
Image: High-magnification micrograph of senile cardiac amyloidosis. Photo: courtesy of Nephron.