Galectin-3 is an FDA-cleared blood test available for clinical use in chronic heart failure.
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Study Shows Galectin-3 Predicts Response to Statin Therapy in Chronic Heart Failure – Results Presented at European Society of Cardiology (ESC) Congress 2011
August 29th, 2011
WALTHAM, Mass., Aug. 29, 2011 (GLOBE NEWSWIRE) — BG Medicine, Inc. (Nasdaq:BGMD), a company focused on the development and commercialization of novel, biomarker-based diagnostics, announced today that results from a sub-study of the Controlled Rosuvastatin Multinational Trial in Heart Failure (CORONA) trial were presented at the European Society of Cardiology (ESC) Congress 2011, in Paris, France. The results from the sub-study demonstrated that patients with plasma levels of galectin-3 below the median derived a marked clinical benefit from rosuvastatin (statin) treatment, while no benefit from rosuvastatin (statin) treatment was observed among patients with higher levels of galectin-3.
Results from the original CORONA trial reported in 2007 indicated that there were no significant differences between the rosuvastatin group and placebo in the coronary outcome or death from cardiovascular causes. However, in a secondary analysis, there was a small but statistically significant 8% reduction in hospitalizations for cardiovascular causes in the rosuvastatin group when compared to the placebo group (P<0.001)1.
Recent studies have suggested that 30% or more of typical heart failure is mediated by galectin-3 and that galectin-3-mediated heart failure is a form of heart failure that differs from other forms in several important respects. This observation led to the hypothesis that drugs, including statins, may perform differently in patients with higher or lower plasma levels of galectin-3. The hypothesis was tested in the sub-study of the CORONA trial described above, which involved 1,462 trial participants (approximately 30% of total CORONA trial participants). Results demonstrated that patients with plasma levels of galectin-3 below the median level (≤ 19.0 ng/mL) derived a marked clinical benefit from rosuvastatin treatment, while no benefit was observed in those with galectin-3 values over 19.0 ng/mL. 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. In patients with galectin-3 levels below 19.0 ng/mL, a marked 35% reduction in the primary endpoint was observed (p<0.05). Results were featured in a presentation at the ESC entitled, “Galectin-3 Predicts Response to Statin Therapy in Chronic Heart Failure,” presented by Lars Gullestad, MD, PhD, Professor of Cardiology in the Department of Cardiology at Rikshospitalet University Hospital, Oslo, Norway.
“Heart failure is one of the fastest growing forms of cardiac disease, and a leading cause of death,” said Dr. Lars Gullestad. “However, the fact that heart failure is a heterogeneous condition likely accounts for the reason that so many large controlled trials, such as CORONA, have failed to demonstrate the anticipated benefits. By measuring blood levels of galectin-3, we can segment the heart failure patient population along disease pathways, which enables us to identify a large subgroup that appears to derive a marked clinical benefit from a common statin drug. Although these data should not support discontinuation of statin use in any group of patients with heart failure, they do strongly support the use of statins in patients who have low levels of galectin-3.”
“Heart failure is one of the few major medical conditions which is still predominantly defined based on signs and symptoms regardless of underlying disease pathways,” said Pieter Muntendam, MD, President and CEO of BG Medicine. “We believe that this study is important for two reasons: it supports the underlying premise of the original CORONA trial design – that there are heart failure patients who can derive an important mortality and morbidity benefit unrelated to the statin’s effect on cholesterol, and it further validates that galectin-3-mediated heart failure is distinct from other forms of heart failure.”
The full poster presentation, “Galectin-3 Predicts Response to Statin Therapy in Chronic Heart Failure,” is available: click here.
In conjunction with results presented at ESC, BG Medicine will host an interactive webcast, “Role of Galectin-3 in Therapeutic and Cardiovascular Outcomes — Results from Leading Studies Presented at European Society of Cardiology Annual Meeting,” on August 30, 2011 at 12:00 p.m. EDT (18:00 CEST). Faculty will feature Bertram Pitt, MD, FACC, Professor of Medicine Emeritus, University of Michigan School of Medicine, Division of Cardiology; Lars Gullestad, MD, PhD, Professor of Cardiology, Rikshospitalet University Hospital, Department of Cardiology; and Rudolf de Boer, MD, PhD, Associate Professor in Cardiology, University Medical Center Groningen. Pieter Muntendam, MD, President and CEO of BG Medicine will moderate the session. The program is sponsored by Abbott, Alere, Inc., bioMérieux and Siemens. Further information is available at: http://www.cardiocarelive.com/Galectin-3.
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BG Medicine, Inc. to Host Webcast on Latest Results of Galectin-3 Studies From European Society of Cardiology (ESC) Congress 2011
August 23rd, 2011
Interactive CardiocareLive Event Scheduled for August 30, 2011, 12:00 p.m. EDT
WALTHAM, Mass., Aug. 23, 2011 (GLOBE NEWSWIRE) — BG Medicine, Inc. (Nasdaq:BGMD), a life sciences company focused on the development and commercialization of novel, biomarker-based diagnostics, announced today that it will host an interactive webcast, “Role of Galectin-3 in Therapeutic and Cardiovascular Outcomes — Results from Leading Studies Presented at the European Society of Cardiology Congress 2011.” The webcast will be held on Tuesday, August 30, 2011, at 12:00 p.m. EDT (18:00 CEST), via CardiocareLive, a virtual cardiology congress produced by PlatformQ.
The following ESC presentations will be highlighted in the webcast:
- “Galectin-3 predicts mortality and response to statin therapy in chronic heart failure” — Results of the CORONA study, a multicenter study on the effect of rosuvastatin in heart failure (Program #1782);
- “Galectin-3, cardiovascular risk factors, and outcome in the general population” — The first epidemiological study to report on the prevalence of elevated galectin-3 in the general population and its effect on cardiovascular mortality (Program #4608);
- “Genetic disruption of galectin-3 prevents adverse cardiac remodeling” – Study to investigate the mechanism underlying galectin-3-mediated heart failure (Program #5790); and
- “Pharmacological inhibition of galectin-3 attenuates adverse cardiac remodeling and heart failure” — Preclinical study to investigate the effects of a natural carbohydrate inhibitor of galectin-3 on heart failure development (Program #5801).
The webcast will feature:
- Bertram Pitt, MD, FACC, Professor of Medicine Emeritus, University of Michigan School of Medicine, Division of Cardiology
- Lars Gullestad, MD, PhD, Professor in Cardiology, University Hospital Rikshospitalet, Department of Cardiology
- Rudolf de Boer, MD, PhD, Associate Professor in Cardiology, University Medical Center Groningen.
Dr. Bertram Pitt will provide an introductory presentation on cardiac fibrosis and heart failure. Pieter Muntendam, MD, President and CEO of BG Medicine will moderate the session. This program is sponsored by Abbott, Alere, bioMérieux and Siemens.
To participate in this interactive webcast, please visit the following link on August 30, 2011:
http://www.cardiocarelive.com/en_CA/br/Galectin3/refcode=BGMed_PR.
The scientific program for the ESC Congress is available at: http://spo.escardio.org.
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New Studies on Role of Galectin-3 in Heart Failure to be Presented at European Society of Cardiology (ESC) Congress 2011August 2nd, 2011
WALTHAM, Mass., Aug. 2, 2011 (GLOBE NEWSWIRE) — BG Medicine, Inc. (Nasdaq:BGMD), a company focused on the development and commercialization of novel, biomarker-based diagnostics, announced today that results from several studies utilizing its BGM Galectin-3™ test will be presented at the upcoming European Society of Cardiology (ESC) Congress 2011, to be held in Paris, France, August 27-31, 2011. The presentations will address four important topics related to galectin-3-mediated cardiac disease: (1) the role of galectin-3 in predicting patients’ response to heart failure therapy for select drug classes; (2) the ability of galectin-3 to identify individuals at risk for cardiovascular events prior to their first diagnosis of heart failure; (3) the mechanism and role of galectin-3 in heart failure development; and (4) the opportunity to block galectin-3 using natural carbohydrate compounds and their effects on heart failure development.
“When we initiated the development of a galectin-3 diagnostic test, we postulated that galectin-3 could be responsible for a common and important form of cardiac disease that often leads to heart failure. If proven, we expected that patients with galectin-3-mediated heart failure may respond differently to certain drugs, they may be identified before heart failure is first clinically diagnosed, and the built-in “on-off switch” on the galectin-3 protein could be manipulated to block its activity,” commented Pieter Muntendam, MD, President and CEO of BG Medicine. ”It is exciting to see that the galectin-3 data support our expectations and that these new data will be presented at the ESC meeting.”
In order to provide access to this important information, BG Medicine will also host an interactive webinar, “Role of Galectin-3 in Therapeutic and Cardiovascular Outcomes — Results from Leading Studies Presented at the European Society of Cardiology Annual Meeting,” on August 30, 2011, at 12:00 p.m. EDT (18:00 CEST) via Cardiocare Live, a virtual cardiology congress, presented by the Johns Hopkins University School of Medicine and produced by PlatformQ. The interactive format provides an opportunity for participants to learn more and interact directly with the researchers who have conducted these studies. The faculty will feature Bertram Pitt, MD, FACC, Professor of Medicine Emeritus, University of Michigan School of Medicine, Division of Cardiology; Lars Gullestad, MD, PhD, Professor in Cardiology, Rikshospitalet University Hospital, Department of Cardiology; and Rudolf De Boer, MD, PhD, Associate Professor in Cardiology, University Medical Center Groningen. Pieter Muntendam, MD, President and CEO of BG Medicine will moderate the session. The program is sponsored by Abbott, Alere, Inc., bioMérieux and Siemens. Further details regarding the webinar will be announced closer to the date.
Details for the four ESC presentations described above are provided below:
(1) Title: ”Galectin-3 predicts mortality and response to statin therapy in chronic heart failure”
Presented by: Lars Gullestad MD, PhD
Time: Sunday, August 28, 14:00 — 18:00 CEST (8:00 a.m. — 12:00 p.m. EDT)
Program Title and Location: Poster Session 2: Heart Failure — Left ventricular dysfunction; Posters — Poster Zone C
(2) Title: ”Galectin-3, cardiovascular risk factors, and outcome in the general population”
Author: RA de Boer
Time: Tuesday, August 30, 15:30 — 16:30 CEST (9:30 a.m. — 10:30 a.m. EDT)
Program Title and Location: Global cardiovascular risk and burden; Moderated Posters — Poster Zone C
(3) Title: ”Genetic disruption of galectin-3 prevents adverse cardiac remodeling”
Author: L Yu
Time: Wednesday, August 31, 08:30 — 12:30 CEST (2:30 a.m. — 6:30 a.m. EDT)
Program Title and Location: Poster Session 7: Heart Failure — Left ventricular dysfunction; Posters — Poster Zone C
(4) Title: ”Pharmacological inhibition of galectin-3 attenuates adverse cardiac remodeling and heart failure”
Author: L Yu
Time: Wednesday, August 31, 08:30 — 12:30 CEST (2:30 a.m. — 6:30 a.m. EDT)
Program Title and Location: Poster Session 7: Heart Failure — Left ventricular dysfunction: Posters — Poster Zone C
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Explore the Science Behind Galectin-3 With the Launch of BG Medicine’s New Social Media Platforms
April 5th, 2011
WALTHAM, Mass., April 5, 2011 (GLOBE NEWSWIRE) — BG Medicine (Nasdaq:BGMD) today announced the launch of its @galectin3 Twitter handle and galectin-3 Facebook fan page in an effort to raise awareness of galectin-3, a protein that has been shown to play an important role in the development and progression of heart failure. The launch of the social media platforms coincides with the American College of Cardiology 60th Annual Scientific Session (ACC.11) in New Orleans.
In November 2010, the FDA cleared the company’s Galectin-3 test for use as an aid in the assessment of prognosis in patients with chronic heart failure. Studies suggest that 30% or more of patients with chronic heart failure may have elevated levels of galectin-3. This galectin-3 mediated form of heart failure is associated with progressive fibrosis of the heart muscle, which impairs the heart’s ability to pump.
“Galectin-3 seems to be attracting a lot of attention in the scientific community with approximately 60 papers in the first quarter of this year alone and nearly 1,500 papers since the first publication in 1988,” said Pieter Muntendam, MD, president and CEO of BG Medicine. “Our Twitter and Facebook presence offers a convenient way for scientists and clinicians to follow the scientific developments of galectin-3.”
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Use of Galectin-3 as a Risk Marker for Heart Failure Development to be Presented at American College of Cardiology 60th Annual Scientific Session
April 4th, 2011
WALTHAM, Mass., April 4, 2011 (GLOBE NEWSWIRE) — BG Medicine, Inc. (Nasdaq:BGMD) today announced that results from an initial research study of galectin-3 to identify individuals at risk for the development of heart failure (HF) will be featured in a poster presentation during the American College of Cardiology 60th Annual Scientific Session (ACC.11), to be held April 2-5, 2011 in New Orleans, LA.
The objective of this pilot study was to investigate if elevated galectin-3 levels in acute coronary syndrome (ACS) patients can be used to identify individuals at higher risk for the development of HF. The study was a nested case-control study from PROVE-IT-TIMI 22 among ACS patients randomized to intensive vs. moderate statin therapy. One hundred patients who were hospitalized for new or worsening HF after ACS were matched 1:1 with controls for age, sex, ACS type, and randomized treatment. The study results will be presented by Edward Grandin, MD from the TIMI Study Group, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA.
“Over the past several years, studies have suggested that elevated levels of galectin-3 are associated with an inherently progressive form of heart failure resulting in increased hospitalization and premature death,” noted Pieter Muntendam, M.D., President and CEO of BG Medicine. ”Based on our understanding of the role of galectin-3 as a culprit marker in heart failure, we anticipated that elevated galectin-3 levels could precede the diagnosis of heart failure in many patients and this represents the first study to evaluate this hypothesis.”
“In our pilot study, galectin-3 showed intriguing potential to identify patients with ACS who are more likely to develop heart failure,” said David A. Morrow, MD, MPH, from the TIMI Study Group, Cardiovascular Division, Brigham and Women’s Hospital in Boston and the principal investigator of this study. “Finding individuals at risk for heart failure before the onset of heart failure symptoms might enable new approaches to intervene to prevent this important complication of ACS.”
The results of the study will be presented at as follows:
Presentation Date/Time: Monday, April 4, 2011, 9:30 AM – 10:45 AM Session Title:
Galectin-3 and the development of heart failure after acute coronary syndrome: A pilot experience from PROVE IT-TIMI 22 Presenter: Edward W Grandin, M.D., Clinical Fellow in Medicine Session Type/Location: Poster at Ernest N. Morial Convention Center; Hall F Sessions are embargoed until time of presentation.
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BG Medicine Announces Availability of Galectin-3 Testing Service Through Health Diagnostic Laboratory, Inc.
March 24th, 2011
WALTHAM, Mass. and RICHMOND, Va., March 24, 2011 (GLOBE NEWSWIRE) — BG Medicine, Inc. (Nasdaq:BGMD) and Health Diagnostic Laboratory, Inc. (HDL, Inc.), announced today an agreement under which HDL, Inc. will offer galectin-3 testing services based on the BG Medicine Galectin-3 Test.
The BG Medicine Galectin-3 Test was recently cleared by the FDA as an aid in assessing the prognosis of patients with chronic heart failure. Elevated galectin-3 levels are associated with an inherently progressive form of heart failure that is associated with an increased risk of hospitalization or death. Galectin-3 has been implicated in a variety of biological processes important in heart failure development and progression, including fibrosis. Progressive cardiac fibrosis interferes with the cardiac pump function and increases the risk of death.
The collaboration between BG Medicine and HDL, Inc. provides physicians with convenient access to galectin-3 testing to complement the range of cardiovascular tests already offered by HDL, Inc.
“HDL, Inc. is providing a new model of laboratory testing services to over 5,000 physicians with an emphasis on markers related to cardiovascular disease,” said Pieter Muntendam, MD, President and CEO of BG Medicine. ”The cardiovascular focus of HDL, Inc. makes this an excellent partnership to bring our message of the importance of galectin-3 in cardiac disease to the growing number physicians served by HDL, Inc.”
Heart failure is a serious medical condition characterized by the heart’s inability to pump blood efficiently to meet the requirements of the body’s other organs. According to the American Heart Association, heart failure affects an estimated 5.8 million Americans with 670,000 new diagnoses each year. The estimated direct and indirect cost of this condition in the US is $39.2 billion.
“Galectin-3 further enhances our extensive cardiovascular disease offering,” said Tonya Mallory, CEO and co-founder of Virginia-headquartered HDL, Inc. “Novel markers like galectin-3 are expected to enable a new medical model where physicians can triage patients not only based on their clinical status on the day of the visit, but also based on the type of underlying disease process and its prognostic implications.”
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BG Medicine Announces Issuance of United States Patent for Galectin-3 Testing in Heart Failure
February 16th, 2011
WALTHAM, Mass., Feb. 16, 2011 (GLOBE NEWSWIRE) — BG Medicine (Nasdaq:BGMD), a life sciences company focused on the discovery, development, and commercialization of novel diagnostics based on biomarkers, today announced the issuance of U.S. Patent No. 7,888,137, entitled “Method For Identifying a Subject at Risk of Developing Heart Failure by Determining the Level of Galectin-3 or Thrombospondin-2″ to the University of Maastricht. BG Medicine has an exclusive license to this issued patent, which pertains to galectin-3 testing for individuals at risk for heart failure. The patent term expires in 2026.
“This seminal patent is an important step towards our goal of obtaining broad patent coverage for galectin-3 testing in the area of cardiac disease,” said Pieter Muntendam, MD, President and CEO of BG Medicine. “It has been a remarkable journey from the first discovery of dysregulated galectin-3 in an animal model of heart disease less than a decade ago to FDA clearance of the galectin-3 blood test for clinical use in 2010. We plan to aggressively expand our patent portfolio for this important medical innovation.”
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BG Medicine Announces Nationwide Availability of Galectin-3 Testing Service through LabCorp
January 24th, 2011
Waltham, MA — January 18, 2011 — (BUSINESS WIRE) BG Medicine announced today that Laboratory Corporation of America® Holdings (LabCorp®)now offers galectin-3 testing services using the BGM Galectin-3 test for heart failure. The BGM Galectin-3 test was cleared by the FDA in November 2010 as an aid in assessing the prognosis of patients with chronic heart failure. Elevated galectin-3 levels are associated with an inherently progressive form of heart failure that is associated with an increased risk of hospitalization or death. LabCorp provides convenient access to galectin-3 testing for physicians and their patients throughout the United States.
“The LabCorp collaboration provides a convenient way for physicians nationwide to become familiar with the role of galectin-3 in heart failure and to access and use galectin-3 testing to improve patient outcomes,” said Pieter Muntendam, MD, President and CEO of BG Medicine. “Galectin-3 testing provides new information on the underlying disease process in patients with heart failure to enable more personalized medical management.”
Heart failure is a condition caused by a combination of diseases or factors that damage or overwork the heart muscle, resulting in its inability to pump blood efficiently to meet the requirements of other body organs. This condition often leads to serious medical complications and is a leading cause of death. According to the American Heart Association, heart failure affects an estimated 5.8 million Americans with 670,000 new diagnoses each year. The estimated direct and indirect cost of this condition in the US is $39.2 billion.
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BG Medicine and Siemens Healthcare Diagnostics to Develop Galectin-3 Test for Siemens Automated Immunoassay Platforms
January 6th, 2011
Waltham, MA — January 6, 2011 — (BUSINESS WIRE) BG Medicine, Inc. announced today that it has entered into an agreement with Siemens Healthcare Diagnostics Inc., a division of Siemens Healthcare, one of the world’s largest suppliers of clinical diagnostics to the healthcare industry, for the development and commercialization of a galectin-3 test for Siemens’ automated immunoassay platforms for clinical laboratories.
The automated Siemens galectin-3 assay will offer laboratories a convenient way to measure galectin-3 in plasma or serum. The BG Medicine manual galectin-3 assay was recently cleared by the FDA as an aid in assessing the prognosis of patients diagnosed with chronic heart failure. Elevated galectin-3 levels are associated with an inherently progressive form of heart failure that is associated with an increased risk of hospitalization or death.
“Galectin-3-mediated cardiac fibrosis is proving to be an important underlying condition in certain patients with chronic heart failure, and studies suggest that at least 30% of patients with chronic heart failure may have this form of the disease,” noted Pieter Muntendam, MD, President and CEO of BG Medicine. “This partnership with Siemens will allow the many hospitals around the world that rely on Siemens instruments for their laboratory operations to meet the demand for galectin-3 testing using existing systems and workflow.”
“Siemens Healthcare Diagnostics is committed to the development of new and novel markers to aid in the diagnosis of cardiovascular disease. We are very excited to be partnering with BG Medicine to develop the Galectin-3 biomarker for our platforms, which we believe will be important in advancing the tools available to clinicians to diagnose and manage heart failure,” said Dave Hickey, CEO, Chemistry/Immunoassay, Automation and Diagnostics IT Business Unit, Siemens Healthcare Diagnostics.
Under the agreement, Siemens will be responsible for the development of the test in accordance with certain plans and milestones, and Siemens and BG Medicine will collaborate in support of development of the test and regulatory filings.
This agreement with Siemens follows BG Medicine’s execution of similar agreements in 2009 and 2010 for the development and commercialization of automated galectin-3 assays with other diagnostic laboratory instrument manufacturers, including Abbott, Alere (formerly Inverness Medical), and bioMérieux.
About Siemens Healthcare
The Siemens Healthcare Sector is one of the world’s largest suppliers to the healthcare industry and a trendsetter in medical imaging, laboratory diagnostics, medical information technology, and hearing aids. Siemens offers its customers products and solutions for the entire range of patient care from a single source—from prevention and early detection to diagnosis, and on to treatment and aftercare. By optimizing clinical workflows for the most common diseases, Siemens also makes healthcare faster, better, and more cost-effective. Siemens Healthcare employs some 48,000 employees worldwide and operates around the world. In fiscal year 2010 (to September 30), the Sector posted revenue of 12.4 billion euros and profit of around 750 million euros. For further information please visit: http://www.siemens.com/healthcare.About BG Medicine
BG Medicine is a life sciences company focused on the discovery, development, and commercialization of novel diagnostics based on biomarkers to improve patient outcomes and contain healthcare costs.# # #
FOR MORE INFORMATION, CONTACT:
Michael W. Rogers
EVP & Chief Financial Officer
781-890-1199
mrogers@bg-medicine.com -
BG Medicine Announces New Publication on Prognostic Value of Galectin-3 in Heart Failure Patients
January 4th, 2011
Waltham, MA — January 4, 2011 — (BUSINESS WIRE) BG Medicine, a life sciences company focused on the discovery, development, and commercialization of novel diagnostics, today announced the publication* of a study exploring the predictive value of plasma galectin-3 levels in heart failure (HF) patients with reduced and preserved ejection fraction.
The study was conducted by the Department of Cardiology at the University Medical Centre Groningen in The Netherlands. The results of this prospective study, in which 592 HF patients were studied, confirm that galectin-3 is a strong and independent predictor of adverse outcomes. The prognostic value of galectin-3 remained even after adjustment for established risk factors for poor outcomes in HF, including age, sex, BNP, renal function, and diabetes mellitus.
To download an abstract of the article, click here.
*Citation of the Publication: de Boer RA, et al. Predictive value of plasma galectin-3 levels in heart failure with reduced and preserved ejection fraction. Ann Med. 2010; Early Online, 1–9.
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FOR MORE INFORMATION, CONTACT:
Michael W. Rogers
EVP & Chief Financial Officer
781-890-1199
mrogers@bg-medicine.com
