BG Medicine last month said it would work with the Copenhagen General Population Study to discover and validate novel proteomic biomarkers linked to myocardial infarction.
The CGPS collaboration is part of the High-Risk Plaque Initiative, a four-year, $30 million research effort launched a year ago to develop better methods and technologies that can identify individuals at risk for heart disease. Specifically, the initiative is aimed at improving the understanding and management of high-risk plaque, which is closely associated with heart attacks and stroke.
Drug makers Merck and AstraZeneca, medical-imaging manufacturer Philips Electronics, and health insurer Humana are partners on the initiative.
The CGPS collaboration builds upon work in which Waltham, Mass.-based BG Medicine used blood samples from the Duke University CATHGEN biobank to find biomarkers for vulnerable plaque. Based on a retrospective study, BG Medicine has been able to find 12 protein markers with a sensitivity and specificity of 78 percent.
But according to BG Medicine CEO Pieter Muntendam, that study was relatively small and not representative of the general population, “and based on these findings, we decided it was time to take this to a larger general population study and that’s where the Copenhagen General Population Study came in.”
While BG Medicine has several broad cardiovascular disease programs ongoing, its collaboration with CGPS is targeted specifically toward myocardial infarction. The beauty of the CGPS work is that it has “pure MI cases, so for a discovery study, which is what [our] first study is, that is the best population,” Muntendam told ProteoMonitor.
CGPS has provided BG Medicine 900 samples from 250 individuals who developed myocardial infarction within four years of giving blood samples despite showing no prior symptoms.
With them, BG Medicine will attempt to validate their findings from the Duke CATHGEN research while casting a wider net to identify additional biomarkers, Muntendam said, and do a broad profiling of patients at risk to develop myocardial infarction.
According to Muntendam, the gold standard study in the area of cardiovascular disease biomarkers is one done by Thomas Wang and colleagues that evaluated the predictive power of 10 previously reported biomarkers for major cardiovascular events.
Whereas that study looked at 169 individuals who developed heart diseases over a seven-year period, the BG Medicine/CGPS research will look at 250 cases over four years and measure possibly hundreds of biomarkers, according to Muntendam.
“So it really has the potential to be a very significant study in terms of contribution,” he said.
“It’s very exciting for those in the biomarker space because for the first time, I think the world realizes that we are the cornerstone of changing medicine.”
Muntendam declined to provide financial details about the collaboration and said that it will be carried out on an ongoing basis. If the results are positive from this initial case-control phase of the project, the company may broaden it to a case-cohort study in which it will look at additional test subjects to validate its findings.
The discovery phase is anticipated to be finished by the end of the year.
In addition to the CGPS deal, BG Medicine last month announced a deal with ACS Biomarkers to develop and commercialize a diagnostic test for acute atherothrombosis. The test is to be based on two peptide biomarkers discovered by the Cardiovascular Research Institute Maastricht.
Aside from saying the deal involves royalty and milestone payments, Muntendam declined to elaborate on the financial terms of the agreement.
Unlike the CGPS collaboration aimed at identifying predictive markers, the two peptide markers may diagnose actual vascular plaque ruptures and so have myocardial infarction already. The test would identify plaque rupture early on and before the common signs and symptoms of heart attack or stroke appear.
According to Muntendam, women in particular often don’t experience the typical pre-symptoms of a heart attack, “and a blood test … would help tremendously in the management of these patients.”
The test could also be used to help diagnose less severe conditions such as transient ischemic attacks, which are considered harbingers of impending stroke.
Significant work remains to validate the two markers, however, and a test based on them is still years away, he said.
In December, the company launched the BioImage Study as the next phase of the High-Risk Plaque Initiative. According to a press release, the study seeks to integrate “a set of clinical measurements that may reliably and reproducibly predict those who are most at risk [for] heart attack or stroke associated with high-risk plaque, [and] who would benefit from innovative therapies.”
BG Medicine will discover and validate biomarkers from blood that can predict heart attack and stroke from high-risk plaque. Those biomarkers would then be correlated with images of their hearts and cardiovascular system that will be taken as part of the study. Imaging will be done via magnetic resonance and computed tomography systems provided by Philips. Humana is in the process of recruiting 7,300 participants.
BG Medicine is also developing a diagnostic based on the galectin-3 protein, which has been associated with poor outcomes in heart failure. The company anticipates it will file an application with the US Food and Drug Administration to bring to market the laboratory based test at the end of this year, Muntendam said.
“People realize that this new medicine that we’re moving toward is going to be based on new diagnostics and we’re going to go to a molecular, biological medical model, and it’s very exciting for those in the biomarker space because for the first time, I think the world realizes that we are the cornerstone of changing medicine,” he said.