Interleukin Genetics, Inc. and the University of North Carolina at Chapel Hill Announce Key Genetic Findings from Clinical Study on Osteoarthritis that are Predictive of Disease Progression

WALTHAM, Mass., Sept. 21 /PRNewswire/ -- Interleukin Genetics, Inc. (OTC QB: ILIU) and the Thurston Arthritis Research Center at the University of North Carolina at Chapel Hill announced today findings from a large clinical study to evaluate the role of genetic factors in osteoarthritis progression which showed patients with radiographic evidence of knee osteoarthritis who inherited a specific pattern of genetic variations in the interleukin-1 receptor antagonist (IL-1Ra) gene were almost twice as likely to progress to severe disease as other patients. Results from the study, which followed 1,154 patients for up to 11 years, will be presented this week at the World Congress on Osteoarthritis in Brussels, Belgium.

Interleukin Genetics identified and holds patents on genetic patterns that lead to over-production of interleukin-1 (IL-1), one of the key chemicals involved in cartilage and bone destruction, and on specific genetic patterns in the naturally occurring inhibitors that are predictive of IL-1 and of OA progression.  The study demonstrated that three specific genetic patterns commonly found in the osteoarthritis population are strongly predictive of different risks for progression of osteoarthritis once it has been diagnosed.  

The study, the Johnston County Osteoarthritis Project, led by Dr. Joanne Jordan, the Herman & Louise Smith Distinguished Professor of Medicine and Chief, Division of Rheumatology, Allergy, and Immunology at the Thurston Arthritis Research Center of the University of North Carolina at Chapel Hill, is the first of its kind to include both African-Americans and Caucasians, as well as inclusion of genetic, radiographic, serologic, physical and functional examinations of its participants.

"The strong association shown in this study between progressive OA and the IL-1Ra gene variations, as well as the body of previous related published research, might suggest that this IL-1Ra genetic information could be tested as a tool to identify high-risk patients for participation in clinical trials for the development of a much-needed disease modifying OA drug," said Dr. Jordan.

Interleukin Genetics previously reported variations in the gene for IL-1Ra are strongly associated with severe knee osteoarthritis and this clinical study validates the Company's earlier findings and other previous studies that have implicated the anti-inflammatory protein IL-1Ra in progression to severe disease.  

Although osteoarthritis (OA) is the greatest cause of physical disability in the U.S., there are currently no drugs approved that modify the disease progression. One of the challenges to development of new drugs in OA has been the lack of tools that predict which OA patients are more likely to progress to severe disease, thereby making clinical trials more complicated and expensive.

According to the U.S. Department of Health and Human Services, Osteoarthritis was ranked among the top 10 most expensive medical conditions to treat. In 2005 alone it cost $34 billion, with joint replacement surgery absorbing most of the cost.

"Drug development for OA has been challenging, in part due to the difficulty of enrolling patients who are likely to exhibit disease progression during the study. There appears to be strong potential to use the IL-1Ra genetic patterns to select for clinical trials patients who are more likely to benefit from an effective drug," said Dr. Kenneth Kornman, Chief Scientific Officer, Interleukin Genetics. "A genetic test also would have strong clinical utility for physicians to better manage patients who will more likely progress to a severe form of the disease and require surgery."

The 1,154 subjects in the Johnston County Osteoarthritis Project, directed by Dr. Jordan were monitored for a period between 4 and 11 years to study initiation or progression of osteoarthritis. Subjects were analyzed for genetic markers that predicted those subjects who remained stable and those subjects who progressed to severe osteoarthritis, as measured radiographically. Nine genes were found to be associated with osteoarthritis progression, with the strongest prediction of progression from combinations of gene variations in the gene for IL-1Ra.

About Interleukin Genetics

Interleukin Genetics, Inc. (OTCQB: ILIU) develops and markets a line of genetic tests under the Inherent Health® brand.  The products empower individuals to prevent certain chronic conditions and manage their existing health and wellness through genetic-based insights with actionable guidance. Interleukin Genetics leverages its research, intellectual property and genetic panel development expertise in metabolism and inflammation to facilitate the emerging personalized healthcare market. Interleukin Genetics' flagship products include its proprietary PST® genetic risk panel for periodontal disease and tooth loss susceptibility sold through dentists, and the Inherent Health Weight Management Genetic Test that identifies the most effective diet and exercise program for an individual based on genetics. Interleukin Genetics is headquartered in Waltham, MA and operates an on-site, state-of-the-art DNA testing laboratory certified under the Clinical Laboratories Improvements Act (CLIA).  For more information please visit www.ilgenetics.com.

About the Thurston Arthritis Research Center

The Thurston Arthritis Research Center was established at the University of North Carolina's School of Medicine in 1981. Its mission is to investigate the causes, consequences and treatments of arthritis and autoimmune diseases and to reduce their impacts on patients, their families and society. In 1994, thanks to a generous lead donation from Doc J. Thurston Jr., a free standing multi-purpose research facility was built and named in his honor. The Thurston/Bowles Building is the first building on UNC campus to be funded primarily by private philanthropy. Today, Thurston has more than 70 researchers and physicians from 17 different departments in the Schools of Medicine, Nursing, Public Health, Pharmacy and Dentistry who collaborate to achieve the center's mission. Thurston has proudly served the people of North Carolina with a long tradition of excellence. 

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, 2009, 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.

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Ken Kornman

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SOURCE Interleukin Genetics, Inc.