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BG Medicine Inks CRADA with NHLBI, BU to ID Heart Disease Markers from Framingham Study

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Under a cooperative research and development agreement with the National Heart, Lung, and Blood Institute and Boston University, BG Medicine will conduct a series of studies to uncover novel molecular markers for heart disease and early detection of metabolic syndrome.

Researchers from NHLBI, BU, and BG Medicine will use the Waltham, Mass.-based biotechnology company's proteomic profiling platform to study approximately 800 protein biomarkers in more than 8,000 blood samples from participants in the Framingham Heart Study. The project also aims to look at gene expression changes associated with the biomarkers.

According to BG Medicine, research conducted under the five-year CRADA could lead to the development of a new blood test that predicts patients at risk for heart disease and metabolic syndrome, a condition comprising abdominal obesity, hypertension, and insulin resistance that increases the risk of CVD and diabetes.

The collaboration could also lead to the development of new targeted drugs, the study partners noted.

The study marks the first time in the Framingham Heart Study's 60-year history that the project has joined forces with a commercial firm to advance research.

FHS began in 1948 with an original cohort of 5,209 men and women between the ages of 30 and 62 from the town of Framingham, Mass. Although the original study participants at the time of enrollment had not developed overt symptoms of CVD or suffered a heart attack or stroke, the goal was to study the development of cardiovascular disease over time.

Today, more than 9,000 participants spanning three generations are enrolled in FHS. The project is funded by NHLBI and conducted in collaboration with BU's School of Medicine and School of Public Health.

"This research partnership could ultimately lead to simple blood tests for heart disease that could help us identify high-risk individuals earlier so they can take action sooner to prevent heart attacks and stroke," said NHLBI Director Elizabeth Nabel in a statement.

Data from studies conducted under this CRADA will be accessible to other scientists through the National Center for Biotechnology Information's Database for Genotype and Phenotype.

The Tools

Called the Systems Approach to Biomarker Research in Cardiovascular Disease (SABRe CVD), the initiative's main goal is to identify and validate new protein markers.

"We're looking for proteomic and metabolomic signatures" associated with heart disease and metabolic syndrome "without a pre-defined target," BG President Pieter Muntendam told Pharmacogenomics Reporter this week. "We measure whatever we can find and we're looking at novel signatures."

For proteomic profiling, BG Medicine will use Applied Biosystems' labeling kit and plans to look at 800 proteins in a 100 µL sample. BG Medicine's technology platform can get down to the 10 nanogram/µL range, according to the company. "So, we get to a level where you find many of the proteins of interest … that can play a role in" heart disease, Muntendam said.

The studies will have a case-control design, and initially look for novel markers in approximately 1,000 samples. "Once the discoveries are made, we'll then have opportunities in the broad population," Muntendam said. "So, follow-up studies could include up to 8,000 samples."

BG Medicine is conducting other biomarker studies related to CVD that could inform the current project, but Muntendam said the company plans to ensure that its work with the Framingham study is unbiased.

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For example, the company just completed a study using samples from the Copenhagen Heart Study that began last February [see PGx Reporter 2-13-08]. BG Medicine has "made some very interesting discoveries on those samples," Muntendam noted, adding that the researchers will likely look for similar biomarkers in the FHS samples.

However, despite having proteins of potential interest in hand, "the way we plan to operate for Framingham is that we're going to go in unbiased," Muntendam said. "We're going to measure our 800 proteins without an a priori hypothesis as to what the signal could be.

"The biggest challenge for people has been to work unsupervised where you don't go in with an a priori hypothesis … because then you're not looking for something new; you're just looking for something that someone else had pointed you to," he said.

The CRADA would grant certain patent rights to BG Medicine for the development of a diagnostic test. "We have certain rights to in vitro diagnostics that could come out of this," Muntendam said.

Novel Therapeutics

BG Medicine is also participating in the High-Risk Plaque, or HRP, Initiative, which is conducting studies to discover and validate novel blood or imaging biomarkers for atherosclerosis and risk for atherothrombosis. The initiative, which is directed and supported by Merck, AstraZeneca, Abbott, Takeda, and Philips, uses BG Medicine's diagnostics platform in studies to predict patient response to drugs and their risk of developing adverse events from treatments.

BG Medicine's involvement in the initiative also grants the company close ties with the pharmaceutical industry. Based on the discoveries made under the Framingham CRADA for heart disease and metabolic syndrome, these existing research relationships with pharma could help BG Medicine garner targeted drug development partnerships in the future, Muntendam said.

Muntendam noted that pharmas may be interested in data from the FHS study that might shed light on personalizing treatments for patients at high risk for CVD.

"If we … find people who go on to develop heart attack, then there may be a therapeutic opportunity whether or not the biomarker itself identifies another treatment target," Muntendam said. "There is a possibility that this work will yield additional treatment targets."

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