Healthcare Industry News: Acute Coronary Syndrome
News Release - November 26, 2007
Corgenix Releases Clinical Trial Data on AtherOx(TM)AtherOx(TM) Levels Significantly Higher in Patients With Severe Cardiovascular Complications Including Heart Attack and Unstable Angina
DENVER--(HSMN NewsFeed)--Corgenix Medical Corporation (OTCBB:CONX ), a worldwide developer and marketer of diagnostic test kits, has announced promising results from a preliminary clinical trial involving its AtherOxTM test kit. The study was sponsored by Corgenix and Medical & Biological Laboratories, Ltd.
The in vitro diagnostic (IVD) study at the Cardiology Department of Kurashiki Central Hospital in Okayama, Japan, was conducted to measure levels of AtherOx in healthy individuals and patients with severe cardiovascular complications. The initial results of the research study indicate that the test may identify patients at increased risk of major complications from heart disease such as heart attacks or severe chest pain.
The test kits used in the trial were developed at Corgenix using its proprietary AtherOx technology, which measures the presence of oxidized low-density lipoprotein/β2GPI complexes in patients’ blood. Low-density lipoprotein (LDL) is the harmful form of cholesterol that is modified by multiple inflammatory factors frequently referred to as oxidative stress. Oxidized LDL contributes to the initiation and progression of atherosclerotic cardiovascular diseases.
“This is the first definitive study completed utilizing our AtherOx test to look at patients just admitted to the coronary unit with Acute Coronary Syndrome, and the results are quite compelling,” said Corgenix President and Chief Executive Officer Douglass Simpson. “We intend to continue these studies in Japan, as well as here in North America.”
The study involved patients with Acute Coronary Syndrome (ACS) and a control group of healthy individuals. Corgenix’ AtherOx test found significantly higher serum levels of oxLDL/β2GPI complexes (the patented AtherOx complex) in the ACS patients compared to healthy controls, and particularly in those patients with acute myocardial infarction (heart attacks) and unstable angina (severe chest pain).
“The measurement of oxLDL/β2GPI complexes in patients with cardiovascular diseases provides a novel serologic marker for those patients prone or at risk for more severe complications such as heart attack or unstable chest pain,” said Katsumi Inoue, M.D., Director of the Clinical Research Center at the Kurashiki Central Hospital and Principal Investigator of the study. “We intend to continue our study and then publish all of the data in a major medical journal when completed.”
Atherosclerosis is characterized by a gradual thickening of arterial walls due to the excessive accumulation of lipids. Oxidized low-density lipoprotein (oxLDL) is the principal form of cholesterol that accumulates in atherosclerotic lesions or plaques. Unlike native or un-oxidized LDL, oxLDL is a more dangerous kind of LDL that binds to β2-glycoprotein I (β2GPI) to form oxLDL/β2GPI complexes. Stable oxLDL/β2GPI complexes appear to be highly clinically relevant.
Further trials to confirm the initial findings of this new cardiovascular disease risk marker are scheduled in both the U.S. and Japan over the next several years. Cardiovascular disease is the leading cause of death in the U.S. for both men and women. According to current estimates, more than 79 million Americans have one or more type of cardiovascular disease; of these 7.9 million had a heart attack and 5.6 million a stroke. Complications from atherosclerotic diseases are typically chronic with high recurrence and mortality rates.
The AtherOx test kit has not been cleared for in vitro diagnostic use by the U.S. Food and Drug Administration. In all countries where this product has not been cleared or registered, the product shall not be used for diagnostic use as the performance characteristics have not been established.
About Medical & Biological Laboratories, Ltd.
MBL is a leader in biotechnology and diagnostics with headquarters in Nagoya, Japan. The MBL network consists of 21 companies (18 Japanese companies, two US companies, and one in China). The fields of activities of the member companies consist of development of research tools such as genes, mRNA, protein, sugar chain, etc.; research and development of pharmaceuticals for diagnosis and medical treatment; the process from development to production and sale; and investment and consultation. More information is available at www.mbl.co.jp.
About Corgenix Medical Corporation
Corgenix is a leader in the development and manufacturing of specialized diagnostic kits for immunology disorders, vascular diseases and bone and joint disorders. Corgenix diagnostic products are commercialized for use in clinical laboratories throughout the world. The company currently sells over 50 diagnostic products through a global distribution network. More information is available at www.corgenix.com.
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Source: Corgenix Medical
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