IL-1 Genetic Link to Artery Disease Supported By Knock-Out Mouse Publication In `The Journal for Experimental Medicine'.

Business Editors & Health/Medical Writers

SAN ANTONIO--(BW HealthWire)--Feb. 22, 2000

Interleukin Genetics Inc. (Nasdaq:ILGN) announced the publication of a manuscript in "The Journal of Experimental Medicine," Volume 191.

The manuscript describes a knock-out mouse model in which the interleukin-1 receptor antagonist (IL-1ra) gene has been deleted in the animal.

The mouse mutation has been developed by Dr. Gordon Duff, Dr. Martin Nicklin and colleagues at the University of Sheffield. The IL-1ra gene knock-out mice demonstrated severe inflammation in the major arteries, including the coronary arteries, and succumbed to ruptured arterial aneurysms or to vessel stenosis and infarctions of the organs served by the arteries.

The "Journal of Experimental Medicine" article provides new biological evidence to support a major role for the IL-1 genes in coronary artery disease. This role was previously observed in patient studies in work from the Sheffield laboratories, the Mayo Clinic and the NIH study of Atherosclerosis Risk in Communities (ARIC), indicating that differences in the IL-1 genes among individual patients are associated with increased risk for atherosclerosis of the coronary and carotid arteries.

The newly released paper, entitled "Arterial Inflammation in Mice Lacking the Interleukin-1 Receptor Antagonist Gene," was designed to explore the biological significance of the genetic association observed in the clinical studies. In recent years, investigators have determined that inflammation in the coronary arteries may explain which patients with atherosclerosis actually have clinical events, such as heart attacks and strokes. A number of chemical factors participate in the inflammatory response, with one of the most powerful mediators being IL-1. IL-1ra is among the body's most potent natural mechanisms for controlling IL-1, and thus controlling inflammation.

ILGN and its collaborators have reported previously that IL-1 gene variations are a significant risk factor for coronary artery disease. ILGN has filed patents claiming a significant role for IL-1 genetic factors in both heart disease and stroke. A patent has also been filed on the IL-1ra knock-out mouse model. This research is the result of a joint research and development program in cardiovascular diseases between Interleukin Genetics and The Division of Molecular and Genetic Medicine at the University of Sheffield, U.K.

More than one in four Americans, or approximately 60 million adults, have some form of heart disease. Atherosclerosis refers to the progressive blockage of arteries by plaque accumulation and is one of the major causes of heart disease. When atherosclerosis occurs in the arteries that supply blood to the heart, the disease is often referred to as coronary artery disease (CAD). CAD results in heart attacks (myocardial infarctions) when the blood supply, and therefore oxygen, is cut off and heart muscle cells die. Approximately 13.5 million Americans suffer from coronary artery disease, and approximately 500,000 Americans die each year from this disease. Although several risk factors for heart disease have been identified, such as high cholesterol and smoking, these factors explain only about one-half of first heart attacks. It is now known that inflammation in the arteries is a major part of the biological process that leads to atherosclerosis and the resulting myocardial infarctions and strokes. Chemicals, such as IL-1, that regulate inflammation, and the genes involved in control of IL-1, may provide new opportunities to identify individuals at high risk for future heart disease as well as providing new targets for drugs to prevent heart disease and strokes.

Interleukin Genetics discovers, develops and commercializes diagnostic tests and therapeutics based on genetic factors that regulate control points in the inflammatory processes. ILGN is developing genetic susceptibility tests for osteoporosis, coronary artery disease, complications of diabetes, asthma, pulmonary fibrosis and meningitis/sepsis. PST(R), a test predictive of risk for periodontal disease, is currently available in the U.S. and most of Europe. ILGN also develops and licenses bioinformatics tools, such as BioFusion(R), to pharmaceutical companies for use in drug discovery and development.

PST(R) is a registered service mark of Interleukin Genetics Inc. Additional information can be found on Interleukin Genetics' Web site at www.ilgenetics.com.

Certain statements contained herein are "forward-looking" statements (as such term is defined in the Private Securities Litigation Reform Act of 1995). Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, risk of market acceptance of Company products, risk of technology and products obsolescence, delays in development of products, reliance on partners, competitive risks and those risks and uncertainties described in the Company's Form S-3 filed July 23, 1999, as amended (Commission file No. 333-83631), and the Company's Annual Report on Form 10-KSB for the year ended Dec. 31, 1998, and in other filings made by the Company with Securities and Exchange Commission. The Company disclaims any obligation to update these forward-looking statements.