BG Medicine (BGMD) Welcomes La Jolla Pharmaceutical Company (LJPC)'s Announcement Of Positive Top-Line Results Of Phase 2 Clinical Trial Of Novel Pharmaceutical Compound Targeting Galectin-3 In Chronic Kidney Disease
3/12/2014 7:18:05 AM
BG Medicine Welcomes La Jolla Pharmaceutical Company's Announcement of Positive Top-Line Results of Phase 2 Clinical Trial of Novel Pharmaceutical Compound Targeting Galectin-3 in Chronic Kidney Disease
WALTHAM, Mass., March 12, 2014 (GLOBE NEWSWIRE) -- BG Medicine, Inc. (BGMD) welcomed today an announcement by La Jolla Pharmaceutical Company (LJPC) on March 10, 2014 of positive top-line results of its randomized, placebo-controlled Phase 2 trial of the galectin-3 inhibitor compound GCS-100 in chronic kidney disease. The trial met its primary efficacy endpoint of improvement in kidney function, as well as key secondary endpoints including a statistically significant reduction in circulating levels of galectin-3, the molecular target of GCS-100, at the effective therapeutic dose, as measured using the BGM Galectin-3(R) Test.
The U.S. National Institutes of Health and the National Institute of Diabetes and Digestive and Kidney Diseases have noted that recent research has provided important insights into the origins of fibrosis and scar tissue formation that is seen in some forms of kidney disease.  In the kidney, the process of fibrosis is a common pathway for many diseases.  In previous studies, galectin-3 has been demonstrated to be a biomolecular mediator of the processes of fibrosis and inflammation, and in animal models, inhibition of galectin-3 has been shown to improve conditions associated with organ fibrosis. [2,3,4].
"We welcome the important clinical science that this Phase 2 trial represents," said Dr. Paul R. Sohmer, President and CEO of BG Medicine, Inc. "We look forward to the continued advancement of the fundamental science on the biological role of galectin-3 in health and disease."
The BGM Galectin-3(R) Test is cleared by the U.S. FDA as an aid in assessing the prognosis of patients diagnosed with chronic heart failure when used in conjunction with clinical evaluation.
The BGM Galectin-3(R) Test is CE Marked and is available in Europe as an aid in assessing the prognosis of patients diagnosed with acute and chronic heart failure when used in conjunction with clinical evaluation. It is also CE Marked for adults as an aid in assessing the risk of new onset heart failure.
About Galectin-3 and Heart Failure
Galectin-3 is a protein that is involved in fundamental disease processes including the development of fibrosis in organ tissues, and cardiac remodeling, which may lead to 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 hospitalization or death. The BGM Galectin-3(R) 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 please visit www.BG-Medicine.com.
About BG Medicine, Inc.
BG Medicine, Inc. (BGMD), the developer of the BGM Galectin-3(R) Test, 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.
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: our belief that LJPC's Phase 2 trial represents important clinical science; our belief in the clinical significance of being able to inhibit galectin-3 due to its role as a biomolecular mediator of the processes of fibrosis and inflammation; and our belief that our BGM Galectin-3 test plays a critical role in advancing therapies that target galectin-3. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond the Company's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. These risks and uncertainties include, among other things, the factors discussed under the heading "Risk Factors" contained in BG Medicine's annual report and quarterly reports filed with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and BG Medicine disclaims any obligation to update the information contained in this press release as new information becomes available.
1. http://www.niddk.nih.gov/news/research-updates/Pages/kidney-damage-new-insights-initiation-new-targets-therapy.aspx. Dated January 31, 2013 Accessed March 11, 2014.
2. Henderson NC, Mackinnon AC, Farnworth SL, et al. Galectin-3 expression and secretion links macrophages to the promotion of renal fibrosis. Am J Pathol. 2008 Feb;172(2):288-98.
3. Henderson NC, Mackinnon AC, Farnworth SL, et al. Galectin-3 regulates myofibroblast activation and hepatic fibrosis. Proc Natl Acad Sci U S A. 2006 Mar 28;103(13):5060-5.
4. Yu L, Ruifrok WP, Meissner M, et al. Genetic and pharmacological inhibition of galectin-3 prevents cardiac remodeling by interfering with myocardial fibrogenesis. Circ Heart Fail. 2013 Jan;6(1):107-17.
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