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Interleukin Genetics and NYU Langone Medical Center Announce Publication of Study on Genetics of Osteoarthritis
Date:12/2/2009

WALTHAM, Mass. and NEW YORK, Dec. 2 /PRNewswire-FirstCall/ -- Interleukin Genetics, Inc. (NYSE Amex: ILI) and NYU Langone Medical Center announced findings from a study performed in collaboration with Duke University on the genetics of osteoarthritis have been published this week in the "Online First" version of the Annals of Rheumatic Diseases and is available at http://ard.bmj.com/cgi/rapidpdf/ard.2009.113043v1.pdf. Results from the study highlight importance of inter-individual variations in the IL-1 receptor antagonist (IL-1Ra) gene as a likely determinant for whether patients with knee osteoarthritis will go on to develop a severe form of the disease. Three commonly occurring variations in the gene for IL-1Ra were found to be strongly and significantly associated with severe knee osteoarthritis, as measured on radiographs.

"This publication helps validate a predominant theory over the last five years that IL-1 is an important driver of osteoarthritis," said Steven B. Abramson, MD, Director of the Division of Rheumatology at the Hospital for Joint Diseases at NYU Langone Medical Center. "This observation for the first time shows that variations of the IL-1 receptor antagonist gene, the natural blocker of IL-1's damaging actions, may determine who is more likely to progress with the disease and require surgery. This finding can help in the clinical management of patients, facilitate the clinical testing of drugs in various stages of development for slowing progression of osteoarthritis and could lead to new treatments for the disease where there currently are none."

Osteoarthritis (OA) is the most prevalent form of arthritis, affecting more than 20 million adults in the U.S., with that number expected to double over the next 50 years. OA is caused by the breakdown of the cartilage cushion in one or more joints of the body leading to pain, limitation in movement, and in many cases joint replacement. Therapy for OA patients involves mostly pain management, and no drugs are currently available to limit the progression of the disease.

"Many trials for osteoarthritis therapies have failed due to the inability to identify the group at highest risk for progression over short periods of time," said Virginia Byers Kraus, MD, PhD, collaborator at Duke University. "The identification of these variations in the IL-1 receptor antagonist gene may form one strategy of identifying such individuals that could help release this major roadblock to developing more effective drugs for osteoarthritis."

Interleukin Genetics identified and holds patents on genetic patterns that lead to over-production of interleukin-1, one of the key chemicals involved in cartilage and bone destruction, and on specific genetic patterns that are predictive of OA progression.

"We're excited at the potential for clinical use of our genetic biomarkers to aid drug companies in the development of a treatment to halt the progression of this crippling disease," said Ken Kornman, PhD, Chief Scientific Officer, Interleukin Genetics, Inc. "This publication is the positive culmination of Interleukin Genetics' research on genetic patterns related to interleukin-1 and dedication by our university partners to better understand and treat this disease."

About the Study

The lack of biomarkers that identify patients at risk for severe OA complicates development of disease modifying OA drugs. This study determined whether inflammatory genetic markers could stratify knee OA patients into high and low risk categories for destructive disease.

Genotype associations with knee OA severity were assessed in two independent Caucasian populations, including one population from NYU Langone Medical Center's Hospital for Joint Diseases and the other from Duke University Medical Center. Fifteen SNPs in six inflammatory genes were evaluated for association with radiographic severity and with synovial fluid collected from a subset of the patients.

All 130 patients met clinical symptomatic criteria and radiographic criteria for OA of at least one affected knee and were over age 38. Patients with histories of corticosteroids, bilateral knee replacements, other forms of arthritis, cancer, or other chronic diseases beyond hypertension or hypercholesterolemia were excluded.

Results of the study showed interleukin-1-receptor antagonist (IL1RN) single-nucleotide polymorphisms (rs419598; rs315952; and rs9005) predicted Kellgren-Lawrence scores independently in each population. One IL1RN haplotype was associated with lower odds of radiographic severity (OR 0.16; 95% CI 0.06-0.40), greater joint space width (JSW; p=0.0038), and lower synovial fluid cytokine levels. Carriage of the IL1RN haplotype influenced the age relationship with severity.

IL1RN Polymorphisms reproducibly contribute to disease severity in knee OA and may be useful biomarkers for patient management by physicians and in the selection of patients in disease modifying OA drug trials.

About Interleukin Genetics

Interleukin Genetics, Inc. (NYSE Amex: ILI) develops and markets genetic tests that empower consumers to prevent chronic diseases of aging and that assist pharmaceutical companies in the development and marketing of targeted therapeutics. The Company leverages its research, intellectual property and biomarker development experience to facilitate the emerging personalized health market. Interleukin Genetics is headquartered in Waltham, MA. For more information please visit www.ilgenetics.com.

Certain statements contained herein are "forward-looking" statements, including statements regarding the potential for clinical use of our genetic biomarkers to aid drug companies in the development of a treatment for osteoarthritis. 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, those risks and uncertainties described in the Company's annual report on Form 10-K for the year ended December 31, 2008, quarterly reports on Form 10-Q and other filings with the Securities and Exchange Commission. The Company disclaims any obligation or intention to update these forward-looking statements.

SOURCE Interleukin Genetics, Inc.


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SOURCE Interleukin Genetics, Inc.
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