Interleukin Genetics and the University of North Carolina at Chapel Hill Announce Presentation of Additional Clinical Study Findings on Osteoarthritis Progression

WALTHAM, Mass., Nov. 9, 2010 /PRNewswire-FirstCall/ -- Interleukin Genetics, Inc. (Pink Sheets: ILIU) and the Thurston Arthritis Research Center at the University of North Carolina at Chapel Hill announced today additional findings from their previously reported 1,154-patient longitudinal study to evaluate the role of genetic factors in osteoarthritis (OA) progression. The new data, which will be presented today for the first time at the American College of Rheumatology Annual Scientific Meeting in Atlanta, GA, indicates patients with radiographic signs of early knee osteoarthritis were genetically different from those without radiographic signs of the disease and progressed to moderate or severe OA at a much greater frequency.

In current clinical settings, patients with early radiographic signs of knee osteoarthritis – as often determined by the Kellgren-Lawrence grading scale (grades 0–4, with 0 being normal and 4 severe OA) – are typically considered non-diseased. As a result, patients with early-stage osteoarthritis may not receive adequate medical management to avoid pain and disability associated with disease progression. These new findings could enable at-risk patients to receive critical early intervention to offset complications associated with moderate and severe disease.

"Patients with early osteoarthritis are frequently classified as 'healthy controls' in disease-related clinical research studies. This new information should allow more explicit identification of truly healthy subjects and should also allow identification of early disease patients who may benefit from new drugs in development to modify the progression of OA," said Dr. Ken Kornman, PhD, Chief Scientific Officer, Interleukin Genetics, Inc.  

The findings are the result of an analysis of 1,154 study participants in the Johnston County Osteoarthritis [JoCO OA] 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. Participants were examined for OA and monitored for a period between 4 and 11 years to study changes in disease characteristics. Subjects at the start of the study were analyzed for genetic markers.

"This is the first study to suggest that people with possible early knee OA on their x-rays, are genetically distinct from those with no x-ray signs of knee OA. This reinforces the idea that these people actually have early OA and should be targeted for early intervention," said Dr. Jordan.  

Of those individuals who were completely free of radiographic signs of knee osteoarthritis at the onset of the study, only 8.5 percent progressed to moderate or severe disease, whereas 33 percent of those with very early radiographic signs of disease exhibited progression. Those with early signs of OA were more likely than those who had no signs of disease to carry certain genetic factors, including variations in both the IL-1 receptor antagonist gene (IL1RA) and the DVWA gene that is involved in collagen formation. Both genes have been previously associated with susceptibility to knee OA and progression to severe disease. The combination of early radiographic signs of disease and carriage of gene variations associated with OA progression appears to identify individuals at increased risk for severe OA.  

About the Study

The JoCO study 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. 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.

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.

Interleukin Genetics previously reported variations in the gene for IL-1Ra are strongly associated with severe knee osteoarthritis and progression.  

Although 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.

About Interleukin Genetics

Interleukin Genetics, Inc. (Pink Sheets: 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 information from the study to allow more explicit identification of truly healthy subjects and identification of early disease patients.  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.

SOURCE Interleukin Genetics, Inc.