Corgenix Medical Corp announced the issuance of one new European patent for the company’s AtherOx® (oxLDL/B2GPI) technology and the publication of an important clinical trial studying oxLDL/B2GPI levels in patients with acute coronary syndrome (ACS).
"We are very pleased to announce these two very important accomplishments," said Douglass Simpson, President and CEO of Corgenix. "The newest patent expands our IP portfolio, and the acute coronary syndrome clinical trial reported remarkable results. Since cardiovascular disease is one of the world’s leading causes of death, the early detection of atherosclerosis has become increasingly important, and we are optimistic about the ability of AtherOx to address this significant market."
The clinical trial was conducted at Saint Mary’s Hospital in Waterbury, Conn., under the leadership of Thomas P. Greco, M.D.
European patent # EP 1 596 198 B, "Method of Measuring Oxidized LDL-Beta2-GP1-CRP Complex" was issued April 7, 2010. The patent is a method patent providing additional European protection to the components and assay procedure used to measure AtherOx complexes in biological samples. The latest patent adds to previous issued U.S. and European patents.
The clinical study, "Oxidized-LDL/B2-Glycoprotein I Complexes Are Associated With Disease Severity and Increased Risk for Adverse Outcomes in Patients With Acute Coronary Syndromes," was published in the American Journal of Clinical Pathology, 2010; 133:737-743.
"Our study showed that patients with severe coronary artery disease (CAD) had significantly higher mean levels of Oxidized-LDL/B2-Glycoprotein I (AtherOx) complexes," said Dr Greco, principal investigator and lead author. "This supports the concept that AtherOx is associated with severity of CAD and demonstrates a 3.5-fold-increased risk for adverse outcomes."
Corgenix, in collaboration with Dr Greco’s and other groups, are investigating additional clinical populations to further assess the utility of AtherOx in determining the level of CAD risk and the means to modify its serum levels to reduce or prevent cardiovascular adverse outcomes.
Corgenix holds exclusive worldwide licensing rights for this technology outside of Japan. The technology is incorporated in the company’s AtherOx product group, a next-generation technology to identify individuals at risk for developing atherosclerotic cardiovascular disease. In all countries where the use of products employing this technology has not been cleared, the products shall not be used for diagnostic use as the performance characteristics have not been established.
Source: Corgenix Medical Corp