and related cardiovascular event risk profile
WALTHAM, Mass., Nov. 17 /PRNewswire-FirstCall/ -- News that decreasing inflammation reduces the incidence of cardiovascular disease confirms the important contribution that Interleukin Genetics, Inc.'s (Amex: ILI), Heart Health Genetic Test will have in helping to identify people who are most at risk.
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Results of the JUPITER (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) study, released November 9, 2008 at the American Heart Association (AHA) Scientific Sessions in New Orleans, LA, showed that a statin drug currently prescribed to lower cholesterol in patients at risk for heart disease also reduced the risk of cardiovascular disease in 45 percent of patients with no history of high cholesterol. These patients did have high levels of C-reactive protein (CRP), a protein associated with arterial inflammation that is not routinely measured.
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Kenneth Kornman, DDS, Ph.D., President and Chief Scientific Officer of Interleukin Genetics, commented, "This groundbreaking study confirms our findings that people with elevated inflammation not associated with a particular disease are at increased risk for first cardiovascular disease events, even if they do not have standard risk factors, such as elevated LDL cholesterol. It also demonstrates that there is something that people, who might have been previously unaware of their risk for serious disease events, can do about it. The next step in this finding is to have a simple test to identify people at life-long risk for elevated inflammation, and increased risk for first cardiovascular disease events. Our genetic test accomplishes this in an extremely user-friendly way."
The core scientific hypothesis of the JUPITER study concerned the role of underlying low-grade inflammation. Patients who had transient factors that could be linked to other known inflammatory conditions, including weight, diabetes, arthritis, lupus, inflammatory bowel disease or those taking immunosuppressant agents, were all excluded from the trial. Of the 89,890 people who were screened for enrollment, 72,088 were considered ineligible; including 25,993 (26.1 percent) who had normal to low cholesterol, but elevated high-sensitivity C-reactive protein.
Given the fact that statin drugs can have side effects and liver toxicity risk, a test that can target people whose low-grade inflammation does not result from such transient factors would be a boon to health care practitioners' determination of whether prescribing statins would be a good choice.
Lewis Bender, Chief Executive Officer of Interleukin Genetics, said, "What we believe is needed to help guide physicians is a biomarker that identifies those patients with underlying transient factors. And that is exactly what our Heart Health Genetic Test is: a risk-predictive marker that does not change. So we are very excited about this week's confirmation of what we have been saying about inflammation and heart disease for a long time."
Interleukin Genetics' Heart Health Genetic Test is available to consumers in the U.S. and Canada under the Gensona(R) brand and marketed by Alticor Inc. The Gensona(R) Heart Health Genetic Test employs a number of single nucleotide polymorphisms (genetic sequence variations called SNPs) to identify specific genetic patterns in the Interleukin 1 genes. These genetic patterns are known to correlate with exaggerated inflammatory responses and increased risk of early cardiovascular disease. The Gensona(R) Heart Health Genetic Test is available in the Personalized Health Products category at Quixtar by e-mail at [email protected]. Quixtar also can be reached at 800-361-2213.
In September, Interleukin Genetics and Access Business Group International LLC, a division of Alticor Inc., agreed to increase access to all intellectual property related to genetic tests jointly developed by Interleukin Genetics and Access Business Group under their research agreements. The agreement gave Interleukin Genetics the right to brand, market, sell and distribute all genetic tests developed using its existing and future intellectual property, either itself or through additional third party licensees.
The JUPITER study enrolled 17,802 subjects in 26 countries, selecting men over 50 and women over 60. All had low levels of LDL cholesterol, which would normally mean that they would not be on statin medications. Half of the subjects were given placebos and the other half received 20 milligrams daily of Crestor, one of the most powerful statins.
The JUPITER study results reinforce earlier findings by Interleukin Genetics, which in May published the results of clinical studies supporting the company's Heart Health Genetic Test to assess cardiovascular risk. The article, titled, "IL1B Gene Promoter Haplotype Pairs Predict Clinical Levels of Interleukin-1Beta and C-reactive Protein," was published in the journal Human Genetics (123:387-398; May 2008) and confirmed prior studies associating variations in the Interleukin 1B (IL1B) gene with the inflammatory response.
Sir Gordon W. Duff, M.D., Ph.D., one of the pioneers in the genetics of inflammatory diseases, was the senior author of the paper. Dr. Duff, former Director of the Division of Genomic Medicine, University of Sheffield, UK, commented, "It is now well recognized that inflammation is an underlying factor in many diseases, including cardiovascular disease. Interleukin-1Beta (IL-1Beta) is a major regulator of inflammation. This paper, from a collaborative team of international researchers, demonstrates that people with specific variation patterns in the IL1B gene had higher levels of IL-1Beta and C-reactive protein (CRP). Studies from our group and others have found that these same IL1B gene variations were associated with an increased risk for cardiovascular disease and an increased risk for myocardial infarction at a younger age, that is, an early first heart attack."
The IL1B gene is among the first gene activated when the body encounters a challenge of almost any type, ranging from bacterial infections to bad cholesterol. IL-1Beta initiates a complex cascade of related immune responses. Interleukin Genetics' approach, started over fifteen years ago, is to study variations in regulatory, or on/off switch, regions for these first mover genes and then link them to biological events and risk of inflammatory disease.
Dr. Kornman, an author on the paper, explained the practical utility of the IL1B genetic information. "We use a simple cheek swab to collect an individual's DNA. Our technologists perform the genetic analysis in our CLIA certified laboratory. A report is generated about an individual's risk for excess inflammation and cardiovascular disease. The privacy-ensured report is sent directly to the individual, who then has access to physicians and genetic counselors to discuss results."
These peer-reviewed results build on prior studies which showed that three gene variations inherited together from a parent, called a haplotype, functioned together to control regulation of the gene producing IL-1Beta. In this study, four specific IL1B haplotype pairs, one from each parent, representing just over half of the study population, were associated with higher tissue levels of IL-1Beta levels, and two of those haplotype pairs were also associated with increased blood CRP levels. CRP is an inflammatory chemical that is well-established as an independent marker of risk for heart disease.
About Cardiovascular Disease
According to the Centers for Disease Control and Prevention, about 700,000 people die annually of cardiovascular disease. Cardiovascular disease involves the heart and vessels and is the number one killer in the U.S., accounting for nearly 30-percent of all deaths. Cardiovascular disease has a number of forms but the most common are myocardial infarction and angina pectoris which affect the heart itself. There are well known environmental risk factors associated with cardiovascular disease such as smoking, diet, inactivity and increased alcohol use. Heredity also plays a factor in cardiovascular disease since other risk factors, like high blood pressure and high LDL cholesterol, tend to run in families. Cardiovascular disease can be reduced by controlling environmental factors and understanding the genetic factors that put people at greater risk for heart disease.
About Interleukin Genetics
Interleukin Genetics, Inc. (Amex: ILI), is a healthcare company that specializes in the development of genetic biomarker tests for sale to the emerging personalized health market. The Company is focused on the future of health and medicine. Interleukin Genetics uses its leading genetics research and scientific capabilities to develop and commercialize innovative diagnostic and risk assessment genetic tests. These products could help to improve an individual's understanding of needed lifestyle changes or of therapeutic products that can be used to better manage their health. Interleukin Genetics has developed and commercialized genetic tests for risk assessment of coronary artery disease, periodontal disease, and general nutrition. Through its AJG subsidiary, the Company also currently offers an array of Nutraceutical and OTCeuticals(R) products, including Ginkoba(TM), Ginsana(R) and Venastat(R) which are sold at the nation's largest food, drug and mass retailers. Interleukin Genetics is headquartered in Waltham, MA. For more information about Interleukin Genetics and its ongoing programs, please visit www.ilgenetics.com.
Certain statements contained herein are "forward-looking" statements including statements regarding our ability to develop diagnostic, personalized nutritional and therapeutic products to prevent or treat diseases of inflammation and other genetic variations, our ability to screen nutritional compounds for their effects on inflammatory responses and other genetic variations, given specific genetic patterns and our ability to make progress in advancing our core technologies. 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, the risk of market acceptance of our products, the risk of technology and product obsolescence, delays in product development, the performance of our commercial partners, the availability of adequate capital, the actions of our competitors and other competitive risks, and those risks and uncertainties described in our annual report on Form 10-K for the year ended December 31, 2007 as amended, filed with the Securities and Exchange Commission, our quarterly reports on Form 10-Q and other filings made by us with the Securities and Exchange Commission. We disclaim any obligation or intention to update these forward-looking statements. Gensona(R) is a registered trademark of Alticor Inc.
Editors Note: Interleukin 1Beta (IL-1Beta) is the name for the protein, whereas Interleukin 1B (IL1B) is the name of the gene.
SOURCE Interleukin Genetics, Inc.
