WALTHAM, Mass., Sept. 23, 2013 (GLOBE NEWSWIRE) -- BG Medicine, Inc. (Nasdaq:BGMD) announced today the publication of the results of a clinical research study conducted at the Massachusetts General Hospital (MGH) that provide further evidence that elevated levels of galectin-3 are predictive of adverse outcomes in chronic heart failure patients and suggest that the prognostic value of this non-invasive biomarker may be enhanced when serial measurements are made over time.
In this clinical research study, which was recently published online in the European Journal of Heart Failure, first author Dr. Shweta Motiwala and colleagues of the Division of Cardiology at the Massachusetts General Hospital demonstrate that stable heart failure patients whose galectin-3 blood levels were greater than 20 ng/ml, when measured at three-month intervals, experienced 50% more cardiovascular events, including unplanned hospitalizations for heart failure, than patients whose galectin-3 levels were consistently lower than 20 ng/ml.1 Further, these research data, which were collected from over 900 outpatient visits, also found that increases in galectin-3 levels above a threshold value of 20 ng/ml between outpatient visits, and increases in galectin-3 levels in excess of 15% at any three-month interval, were also predictive of significantly increased risk of adverse outcomes, including unplanned hospitalizations.
"We believe that the results of this research study further support a large body of evidence regarding the utility of galectin-3 as a predictor of adverse outcomes in chronic heart failure," said Dr. Paul R. Sohmer, President and CEO of BG-Medicine, Inc. "From this study, it appears that serial outpatient testing for galectin-3 may provide additional information that may facilitate decisions regarding the clinical management of stable heart failure patients."
For this clinical research study, galectin-3 levels were measured in plasma samples that had been collected as part of the PROTECT study.2 The study enrolled 151 stable heart failure (HF) patients, with an average age of 63 years, who were followed for a median of 10 months. The HF patients who participated in the study had galectin-3 blood levels drawn at four time points during scheduled outpatient physician visits. Galectin-3 levels independently predicted cardiovascular events even after adjustment for clinically relevant variables such as treatment arm allocation, NT-proBNP level, and kidney function. No effect on galectin-3 levels was observed in association with heart failure medications that provided symptom-related or mortality-related benefits.
"Unplanned hospitalizations and unforeseen cardiovascular events are devastating to heart failure patients and their families, represent a significant challenge to health care providers and continue to be a leading cost burden on healthcare systems," stated Dr. Sohmer. "The results of this study from the Massachusetts General Hospital provide further evidence that galectin-3 testing may help to identify and facilitate triage of those heart failure patients who are at elevated risk of near-term adverse events and of deteriorating cardiac function."
The BGM Galectin-3® test is cleared by the FDA as an aid in assessing the prognosis of patients diagnosed with chronic heart failure when used in conjunction with clinical evaluation.
About Galectin-3 and Heart Failure
Galectin-3 has been implicated in a variety of biological processes important in the development and progression of heart failure. Higher levels of galectin-3 are associated with a more aggressive form of heart failure, which may make identification of high-risk patients using galectin-3 testing an important part of patient care. Galectin-3 testing may be useful in helping physicians determine which patients are at higher risk of death or hospitalization, including 30-day readmission. The BGM Galectin-3® test is to be used as an aid in assessing the prognosis of patients with chronic heart failure, in conjunction with clinical evaluation. For more information visit www.galectin-3.com
About BG Medicine, Inc.
BG Medicine, Inc. (Nasdaq:BGMD) is a commercial stage company that is focused on the development and delivery of diagnostic solutions to aid in the clinical management of heart failure and related disorders. For additional information about BG Medicine, heart failure and galectin-3 testing, please visit www.BG-Medicine.com. The BG Medicine Inc. logo is available for download here
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 belief that the results of the MGH research study further support a large body of evidence regarding the utility of galectin-3 as a predictor of adverse outcomes in stable heart failure; our understanding that serial outpatient testing for galectin-3 may provide additional information that may facilitate decisions regarding the clinical management of stable heart failure patients; and our understanding that the results of the MGH study provide further evidence that galectin-3 testing may help to identify and facilitate triage of those heart failure patients who are at elevated risk of near-term adverse events and of deteriorating cardiac function. 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.
Publication References
1. Motiwala SR, Szymonifka J, et al. Serial measurement of galectin-3 in patients with chronic heart failure: results from the ProBNP Outpatient Tailored Chronic Heart Failure Therapy (PROTECT) study. Eur J Heart Fail. 2013 May 10.
2. Gaggin HK, Mohammed AA, et al. Heart failure outcomes and benefits of NT-proBNP-guided management in the elderly: results from the prospective, randomized ProBNP outpatient tailored chronic heart failure therapy (PROTECT) study. J Card Fail. 2012 Aug;18(8):626-34.