U-M School of Dentistry, Interleukin Genetics Complete Enrollment of Novel Clinical Study
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The University of Michigan School of Dentistry and Interleukin Genetics, Inc. (otcqb:ILIU) announced today the completion of patient enrollment for a landmark clinical study using Interleukin’s PST® Genetic Test to determine if dental patients can be risk-stratified to guide frequency of preventive dental visits and reduce the adverse outcomes of periodontal disease progression, such as tooth loss.
The study, led by William Giannobile, D.D.S., D.Med.Sc., Director of the Michigan Center for Oral Health Research and Chairman of the Department of Periodontics and Oral Medicine at the University of Michigan School of Dentistry, enrolled approximately 5,400 consenting adults. Patients were identified through a large dental claims database with more than 15 consecutive years of documented oral health history. Participants provided a DNA sample and information on other risk factors to allow them to be classified as either low-risk or high-risk for periodontitis progression. Risk classification will be used to assess the frequency of preventive visits that is consistent with maintenance of periodontal health. The study is funded by Renaissance Health Service Corporation, a nonprofit organization focused on the advancement of oral health.
The PST Genetic Test identifies individuals with increased risk for severe and progressive periodontal disease and significant tooth loss based on a proprietary panel of genetic variations that predispose an individual to over-express inflammation.
“For more than 30 years, adult patients have been advised to visit the dentist every six months for an examination and cleaning. However, there appears to be little evidence supporting the frequency of prevention visits in adults, and a recent systematic review concluded that there is insufficient evidence to either support or refute the six month interval for preventive dental visits for adults,” said Dr. Giannobile. “If the clinical outcomes for low-risk patients are not adversely affected by one cleaning per year, it may be possible to move towards more personalized preventive measures for the management of periodontal disease in low-risk individuals, while encouraging more preventive care in high-risk patients.”
“This novel clinical study is applying the principles of personalized medicine to determine if preventive care may be more effectively applied to reduce the complications of severe periodontal disease,” said Kenneth Kornman, D.D.S., Ph.D., Chief Scientific Officer of Interleukin Genetics. “Multiple longitudinal clinical studies have shown that after adjusting for past history of disease, two risk factors – smoking and specific Interleukin-1 genetic variations – were the major determinants of tooth loss in treated patients. We are hopeful that this study will determine if the frequency of dental preventive visits influences periodontal disease outcomes in patients with different risk profiles as a dental application of personalized medicine.”
Approximately 8 to 15 percent of adult Americans have moderate to severe periodontitis, which, if not diagnosed early and treated properly, can lead to tooth loss and major changes in appearance. In addition, clinical studies have associated severe periodontal disease with increased risk for heart attacks, strokes and other systemic diseases. Multiple studies have shown that a small number of risk factors, including smoking, diabetes and genetics, are responsible for much of the differences among patients in the severity and progression of periodontal disease.
About Periodontal Disease and Oral Health Care
According to the American Academy of Periodontology, periodontitis (gum disease) is a chronic inflammatory disease initiated by bacterial accumulations on the teeth. If untreated, or inadequately treated, periodontitis destroys the bone and soft tissues that support the teeth and ultimately leads to tooth loss. Although bacteria are essential for initiating periodontitis, the severity of disease and response to treatment are the result of disease modifying factors including smoking, diabetes, and genetics. Multiple studies have shown that genetic factors are responsible for more than 50 percent of the differences among patients in the severity of periodontal disease. Recent studies link periodontitis with diabetes, heart disease, stroke, premature births, and low-weight births. According to information from the Centers for Disease Control and Prevention, one-fourth of U.S. adults aged 60 and older have lost all of their teeth. In 2009, an estimated $102 billion was spent on dental services in the United States and each year, Americans make about 500 million visits to dentists. More information is available through the American Academy of Periodontology at www.perio.org .
About The University of Michigan School of Dentistry
The University of Michigan School of Dentistry is one of the nation’s leading dental schools engaged in oral health care education, research, patient care, and community service. General dental care clinics and specialty clinics providing advanced treatment enable the School to offer dental services and programs to patients throughout Michigan. Classroom and clinic instruction prepare future dentists, dental specialists, and dental hygienists for practice in private offices, hospitals, academia, and public agencies. Research seeks to discover and apply new knowledge that can help patients worldwide. For more information about the School of Dentistry, visit us on the Web at: www.dent.umich.edu .
About Interleukin Genetics, Inc.
Interleukin Genetics, Inc. (otcqb:ILIU) develops and markets a line of genetic tests under the Inherent Health® and PST® brands. 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. The Company markets its tests through partnerships with health and wellness companies, healthcare professionals and other distribution channels. 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, Mass. and operates an on-site, state-of-the-art DNA testing laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). Earlier this month, Interleukin announced the publication of a peer-reviewed study which found that Interleukin-1 (IL-1) gene variations are associated with increased risk of periodontal disease. The study, which appears on the Journal of Periodontology’s website, in advance of appearing in the print edition, was led by Nadeem Y. Karimbux, D.M.D., Associate Professor of Oral Medicine, Infection and Immunity, Harvard School of Dental Medicine.
For more information, please visit http://www.ilgenetics.com .
About Renaissance Health Service Corporation
Renaissance Health Service Corporation (RHSC) is a leader in the dental insurance industry. It is the parent organization for a group of affiliated companies that collectively is among the largest and oldest group dental benefits providers in the United States, covering 8.6 million people and paying out $2.2 billion in dental benefits as of the end of 2011. In addition, through the RHSC Research and Data Institute, it supports scientific research designed to advance oral health.
Currently, RHSC-affiliated companies employ nearly 1,000 people in offices in Indianapolis and Greenwood, Indiana; Louisville, Kentucky; Okemos and Farmington Hills, Michigan; Albuquerque, New Mexico; Raleigh and Charlotte, North Carolina; Columbus and Cleveland, Ohio; and Nashville, Knoxville, and Memphis, Tennessee.
Certain statements contained herein are “forward-looking” statements, including statements that the clinical studies have the potential to expand the use of the PST® Genetic Test. 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 Interleukin Genetics’ annual report on Form 10-K for the year ended December 31, 2010 and other filings with the Securities and Exchange Commission. Interleukin Genetics disclaims any obligation or intention to update these forward-looking statements.
SOURCE: Interleukin Genetics, Inc.
