The galectin-3 CORONA study was designed to assess whether baseline galectin-3 levels could distinguish a group of patients with heart failure who would derive a clinical benefit from rosuvastatin treatment. Rosuvastatin, known under the brand name CRESTOR(R), is a statin medication indicated for the treatment of high cholesterol and related lipid disorders to reduce the risk of heart attack and stroke. The sub-study involved 1,462 trial participants (approximately one-third of all CORONA trial subjects). Results demonstrated that patients with plasma levels of galectin-3 less than 19.0 ng/mL derived a 35% reduction in primary adverse cardiovascular events while on rosuvastatin treatment compared to placebo, while no comparable benefit was observed in subjects with plasma levels of galectin-3 above 19.0 ng/mL (p=0.036). The primary endpoint was a composite of cardiovascular mortality, non fatal myocardial infarction and non fatal stroke, which were analyzed as time to first event.
"Heart failure is a leading cause of death, and galectin-3 is increasingly recognized as a factor in promoting cardiac fibrosis and poor clinical outcomes in many heart failure patients," said Dr. Lars Gullestad, MD, PhD, Professor of Cardiology in the Department of Cardiology at Rikshospitalet University Hospital, Oslo, Norway, who led the study.
"This important study reaffirms a key premise of our galectin-3 research, namely that galectin-3 identifies heart failure patients with a distinct form of the disease," said Pieter Muntendam, MD, Executive Vice President and Chief Medical Officer of BG Medicine. "We expected that the benefit of certain drugs may be limited to patient groups defined by their level of galectin-3 and this is an excellent example of such differential benefit."
The original CORONA study was designed to evaluate the utility of rosuvastatin treatment for patients with advanced heart failure. Results from that trial, reported in the New England Journal of Medicine in 2007, demonstrated no rosuvastatin benefit on the primary coronary endpoint or on cardiovascular death.2
About BG Medicine, Inc.
BG Medicine, Inc. /quotes/zigman/3133698/quotes/nls/bgmd BGMD +6.53% 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(TM) test for use in patients with heart failure, is available in the United States and Europe. BG Medicine has also developed CardioSCORE, 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 .
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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 and how therapeutic treatment decisions will be influenced by classification of heart failure patients according to galectin-3 levels, our expectations regarding the importance of the galectin-3 data published in the European Heart Journal, and the impact of the galectin-3 data on the sales and marketing of our galectin-3 diagnostic tests. 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.
CRESTOR(R) is a registered trademark of the AstraZeneca group of companies.
1Gullestad L, Ueland T, Kjekshus T, et al. Galectin-3 Predicts Response to Statin Therapy in the Controlled Rosuvastatin Multinational Trial in Heart Failure (CORONA). Eur Heart J. 2012 (Advance Access published April 17, 2012, doi:10.1093/eurheartj/ehs077).
2N Engl J Med 2007; 357:2248-2261. November 29, 2007
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SOURCE: BG Medicine Inc.