Data released this week shows the association of antibodies to the AtherOx complex (anti-AtherOx) with vascular thrombosis (particularly with arterial thrombosis) in patients with autoimmune diseases such as systemic lupus erythematosus (SLE) and anti-phospholipid syndrome. The study looked at 113 SLE patients (94 with secondary anti-phospholipid syndrome and 19 without) and concluded the measurement of anti-AtherOx is significantly better than conventional anti-cardiolipin testing in identifying patients with vascular complications, and suggests the pivotal role of B2GPI in vascular injury and thrombosis.
As with SLE, patients with diabetes also develop significant vascular complications such as atherosclerotic cardiovascular disease. Data from an additional study also released indicated increased levels of the AtherOx complex in patients with diabetes mellitus. This study of 50 Type 2 diabetic patients taking cholesterol-lowering statin drugs (Lipitor(R), Crestor(R) and Zocor(R)) showed reduced levels of AtherOx complexes, suggesting that these statins may also have a beneficial effect in lowering oxidative stress, a significant factor in atherosclerosis.
An interim report was released on a third ongoing prospective study of anti-phospholipid antibodies and AtherOx in patients with coronary artery disease (the CaPS study). While both anti-phospholipid antibodies and AtherOx complexes are present in patients with coronary artery disease, data on 232 patients tested to date showed that increased AtherOx levels were found in coronary patients with more severe disease as judged by cardiac catheterization, and correlated with adverse outcomes or complications such as new angioplasty, stent replacement, failure of coronary artery bypass grafts, heart attacks, strokes and even cardiovascular death. Luis Lopez, MD, Corgenix' Chief Medical Officer said "Interestingly, data from this study suggests the combined presence of both AtherOx complexes and anti-phospholipid antibodies could infer an increased risk for vascular complications in coronary artery disease patients."
Douglass Simpson, Corgenix' President and Chief Executive Officer said, "We are pleased to see this exciting new data on the AtherOx technology. We believe this unique science targets a significant worldwide clinical need, and we look forward to seeing additional data over the next year, leading to the opportunity to bring these products to the market. As new clinical findings continue to validate the utility of AtherOx and anti-AtherOx, we anticipate this technology has the potential to become an important addition to medical care worldwide."
"These findings indicate important relationships between AtherOx and the severity of cardiovascular disease," added Dr. Lopez. "We hope to have the ability to match patients with a treatment that may improve their survival, and if borne out in the ongoing clinical studies now undergoing analysis, could fulfill the promise of reducing the incidence of cardiovascular disease."
The AtherOx technology utilizes oxidized low-density-lipoprotein (oxLDL) complexed with the plasma protein B2GPI. Although oxLDL has been implicated in cardiovascular disease, clinical data demonstrates that the determination of AtherOx, rather than oxLDL alone, is more predictive of the risk of progressive atherosclerotic cardiovascular disease. Corgenix licensed this technology in 2002, and is developing several products util izing this unique platform. Two U.S. patents have been issued and several others are pending.
Corgenix' clinical collaborators for the new AtherOx data include Thomas P. Greco, MD, Department of Medicine of Saint Mary's Hospital and Yale University School of Medicine, and Eiji Matsuura, PhD, Associate Professor, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.
Products using the AtherOx technology have not been cleared by the U.S. Food and Drug Administration for in vitro diagnostic use in the United States. In all countries where the use of this product has not been cleared by local regulating agencies, products using this technology shall not be used for diagnostic use as the performance characteristics have not been established. Two AtherOx products are CE-marked.
About Corgenix Medical Corporation
Corgenix is a leader in the development and manufacturing of specialized diagnostic kits for vascular diseases, immunology disorders, and bone and joint disorders. Corgenix diagnostic products are commercialized for use in clinical laboratories throughout the world. The company currently sells over 52 diagnostic products through a global distribution. More information is available at www.corgenix.com.
Statements in this press release that are not strictly historical facts are "forward looking" statements (identified by the words "believe", "estimate", "project", "expect" or similar expressions) within the meaning of the Private Securities Litigation Reform Act of 1995. These statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, continued acceptance of the Company's products and services in the marketplace, competitive factors, changes in the regulatory environment, and other risks detailed in the Compan y's periodic report filings with the Securities and Exchange Commission. The statements in this press release are made as of today, based upon information currently known to management, and the Company does not undertake any obligation to publicly update or revise any forward-looking statements.
Lipitor(R) (atorstatin calcium) is a registered trademark of Pfizer
Crestor(R) (rosuvastatin calcium) is a registered trademark of AstraZeneca
Zocor(R) (simvastatin) is a registered trademark of Merck & Co. Inc.
Corgenix Medical Corp.
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