Study Reports in Journal of American College of Cardiology That Those in General Population With Elevated Galectin-3 Levels Have Significantly Increased Risk of Developing Heart Failure
WALTHAM, Mass., Aug. 30, 2012 (GLOBE NEWSWIRE) -- BG Medicine, Inc. (Nasdaq:BGMD), a company focused on the development and commercialization of novel cardiovascular diagnostics, announced today that the study, "Galectin-3, a Marker of Cardiac Fibrosis, Predicts Incident Heart Failure in the Community," was published online in the current issue of the Journal of the American College of Cardiology1 (JACC). The study, conducted by the National Heart, Lung, and Blood Institute's (NHLBI) Framingham Heart Study, was designed to determine whether elevated levels of galectin-3 in the population at large identify those who are at increased risk for the development of heart failure. Galectin-3 levels were measured in blood specimens collected from 1996-1998 as part of a routine examination of 3,353 participants enrolled in the NHLBI-supported Framingham Offspring Cohort. The study demonstrated that men and women with baseline blood levels of galectin-3 in the highest quartile had heart failure incidence rates that were more than twice as high as those of all other study participants, over a ten year follow-up period.
"Our research at Framingham represents the first U.S.- based large-scale study to examine whether elevated levels of galectin-3 in the population at large can identify people who may be at risk for development of heart failure," said
, M.D., Director, Framingham Heart Study, National Heart, Lung, and Blood Institute
. "Galectin-3 is associated with cardiac fibrosis, which plays an important role in the development of heart failure, so it may be useful in identifying patients at high risk for heart failure prior to the onset of symptoms and could point the way to earlier prevention and treatment strategies."
"The results published in JACC emphasize the significance of being able to detect factors that impact the identification and progression of heart failure, as nearly one in six people in the general adult population may have elevated levels of galectin-3 and be at risk," said
, President and CEO of BG Medicine. "As part of our corporate strategy to develop and commercialize cardiovascular diagnostics that address significant medical needs, we filed a 510(k) for an expanded indication for the BGM Galectin-3®
test with the U.S. Food and Drug Administration
(FDA) in May 2012
, and have obtained CE Mark in Europe. Subject to FDA
clearance, the new application would expand the indicated use of our galectin-3 test to the general adult population to identify those with elevated levels of galectin-3, which is associated with an increased risk for the development of new-onset heart failure."
About Galectin-3 and Heart Failure
Galectin-3 is a unique carbohydrate-binding lectin, or protein, that binds to carbohydrates called beta-galactosides. Galectin-3 has been implicated in a variety of biological processes important in the development and progression of heart failure, and is believed to be a primary mediator of progressive cardiac fibrosis (abnormal thickening and stiffening of the heart muscle) and adverse remodeling (changes in the structure of the heart). Heart failure affects an estimated 5.8 million Americans, with approximately 670,000 new cases occurring each year. The direct and indirect cost of heart failure in the United States for 2010 is estimated to be $39.2 billion.
About the Framingham Heart Study
Led by the National Heart Lung and Blood Institute (NHLBI), the Framingham Heart Study is a leading observational, multi-generational study designed to track the development of cardiovascular disease and its common contributing factors. The study was initiated in 1948 and has been the source of key research findings regarding the contributions of hypertension, high cholesterol, cigarette smoking and other risk factors to the development of cardiovascular disease.
About BG Medicine, Inc.
BG Medicine, Inc. (Nasdaq:BGMD) is a life sciences company focused on the discovery, development and commercialization of novel cardiovascular diagnostics to address significant unmet medical needs, improve patient outcomes and contain healthcare costs. The Company's first commercialized product, the BGM Galectin-3® test for use in patients with heart failure, is available in the United States and Europe. BG Medicine is also developing the CardioSCORE TM test, a blood test designed to identify individuals at high risk for near-term major cardiovascular events, such as heart attack and stroke. For additional information about BG Medicine, heart failure and galectin-3 testing, please visit www.bg-medicine.com and www.galectin-3.com.
1Ho, J, Liu C, Lyass A, et al. Galectin-3, a Marker of Cardiac Fibrosis, Predicts Incident Heart Failure in the Community. J Am Coll Cardiol 2012 (Published online August 29, 2012, http://dx.doi.org/10.1016/j.jacc.2012.04.053).
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Special Note Regarding Forward-looking Statements
Certain statements made in this news release contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended, that are intended to be covered by the "safe harbor" created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "will," "should," "could," "seek," "intend," "plan," "estimate," "anticipate" or other comparable terms. Forward-looking statements in this news release address our expectations concerning the role that galectin-3 plays in heart failure, our beliefs regarding the importance of galectin-3 data published in the Journal of the American College of Cardiology, our beliefs regarding the importance of the Framingham Heart Study results and the relevance of the results to our 510(k) submission, and our beliefs that earlier identification of patients using our galectin-3 test may improve patient outcomes. Forward-looking statements are based on management's current expectations and involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of our recent filings with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.
CONTACT: Michael W. Rogers
EVP & Chief Financial Officer