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| 8-K - INTERLEUKIN GENETICS INC | v194296_8k.htm |
| EX-99.1 - INTERLEUKIN GENETICS INC | v194296_ex99-1.htm |
EXHIBIT
99.2
INTERLEUKIN
GENETICS, INC. AND THE UNIVERSITY OF MICHIGAN TO
ASSESS
PREDICTIVE VALUE OF NEW GENETIC TEST FOR PERIODONTAL
DISEASE
·
Large Landmark Clinical Study
Designed to Demonstrate Benefits of Interleukin
Genetics’ newest PST® Genetic Test for Prevention of
Periodontal Disease and Tooth
Loss
·
Study Results Expected to Establish
Reimbursement Coverage for Test
Waltham,
Mass. and Ann Arbor, Mich. – August 12, 2010 – Interleukin Genetics,
Inc. (NYSE Amex: ILI) announced today that the Company has signed an agreement
with the University of Michigan to conduct a landmark clinical study on risk
factors predictive of periodontal disease progression to tooth loss using a
new version of Interleukin Genetics’ PST genetic test. PST is the
Company's genetic test brand that 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. The clinical study using a large dental claims
database will be conducted and led by Dr. William Giannobile, Director of the
Michigan Center for Oral Health Research (“MCOHR”) at the University of
Michigan School of Dentistry and is designed to test whether risk factors,
including genetic information, can guide more successful intervention and thus
reduce the adverse outcomes of periodontal disease, such as tooth
loss.
An
estimated 75 percent of American adults have some form of periodontal disease,
and approximately 20-25 percent 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 attack, stroke and low
birth-weight babies. Multiple studies have shown that genetics are responsible
for much of the differences among patients in the severity of periodontal
disease.
“We’re
pleased to embark upon this clinical study with the University of Michigan
School of Dentistry aimed at using the PST test as one part of periodontitis
risk assessment to guide preventative services to reduce the incidence and
complications of periodontal disease,” said Dr. Kenneth Kornman, President and
Chief Scientific Officer of Interleukin Genetics, Inc. “One of the goals of
personalized health care is to detect disease earlier and prevent it more
effectively. With research suggesting that individuals with severe periodontal
disease are at risk for other chronic disease complications, we have a unique
opportunity to leverage genetic science to provide an integrated approach to
early detection, prevention and management of oral health.
“This
will be the largest clinical study ever conducted to evaluate the application of
genetic information for the prevention of periodontal disease,” said William
Giannobile D.D.S., D.Med.Sc., University of Michigan Najjar Professor of
Dentistry and Director of MCOHR. “The results from this study could
prove valuable for setting up new prevention strategies based on risk assessment
tools, including genetic information. Results from the study may lead
to a significant improvement in the allocation of critical oral care resources
and demonstrate the benefits of applying a personalized medicine approach to
improving health outcomes.”
Molecular
biomarkers are now being used in various ways to provide an individual patient
with optimal treatments. One of the major rationales for personalized healthcare
involves guiding preventive services to more effectively prevent complications
of common chronic diseases of aging, such as periodontitis, and to better
allocate overall resources.
“This
clinical study may provide findings that could potentially lead to greater
adoption and widespread reimbursement of our important PST genetic
test. We are excited to be working with our partners on this
program,” said Lewis H. Bender, Chief Executive Officer of Interleukin
Genetics.
About
the Study
This
study, which is expected to begin in the fall and take approximately 12 months
to complete, will determine if dental patients can be stratified using clinical
and biomarker parameters to guide frequency of preventive services to
effectively prevent periodontitis progression. The study will enroll
approximately 4,000 consenting individuals with more than 15 consecutive years
of documented oral health history. Information
on periodontitis risk factors and genetic information will be collected from
participants to assess the frequency of preventive visits that is consistent
with maintenance of proper periodontal health in patients classified as either
low-risk or high-risk for periodontitis progression. This study is
being funded by Renaissance Health Service Corporation, a nonprofit organization
focused on the advancement of oral health.
About
PST®
PST® is a
genetic test that analyzes genes for variations that identify an individual’s
predisposition for over-expression of inflammation and risk for more severe
periodontal disease. The PST genetic test identifies specific
polymorphisms (genetic variations) in genes that regulate the production of
interleukin cytokines. Higher gingival levels of these proteins are
associated with destruction of soft tissue attachment and bone, and increased
severity of periodontitis in certain patient populations. The new PST
product that will be evaluated is predictive of severe disease and tooth loss
for all ethnic populations. Results from several previous clinical
studies indicate that certain inflammatory cytokine levels in the gingival
crevicular fluid were significantly higher in PST positive patients than in
patients who were PST negative. PST testing need only be done once in a lifetime
and identifies “at risk” patients early on to enable targeted
treatment. This objective information allows the dentist and
hygienist to better guide treatment to reduce complications and costs associated
with more severe periodontitis. The test also helps to establish long-term
patient relationships based on the patient’s genetic
predisposition.
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 and premature,
low-weight births. According to information from the Center 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
Michigan Center for Oral Health Research
The
Michigan Center for Oral Health Research (MCOHR), a unit within the School
of Dentistry, serves the School, the dental profession, and the public in the
translation of basic knowledge into new clinical therapies. MCOHR also
supports the evaluation of existing therapies in contexts in which there are
important evidence gaps in order to improve oral, dental and craniofacial
health. 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 and is currently the leading dental research
institution in the U.S. as judged by research funding. Research at the School of
Dentistry 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
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. The PST Test is a proprietary
genetic test panel developed by Interleukin Genetics that analyzes single
nucleotide variations among a number of genes to create a risk profile for
periodontal disease and tooth loss. The Company also has a line of genetic tests
marketed under the Inherent Health brand (www.inherenthealth.com). Tests
are analyzed in Interleukin Genetics’ CLIA-certified laboratory. For more
information please visit www.ilgenetics.com.
Certain
statements contained herein are “forward-looking” statements including
statements regarding the potential utility of the Company’s PST® Genetic Test
and the potential of the study to lead to reimbursement coverage for
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, the risk of market
acceptance of the Company’s products, the risk of technology and product
obsolescence, delays in product development, the performance of commercial
partners, the availability of adequate capital, the actions of competitors and
other competitive risks, and 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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MEDIA
CONTACTS:
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Erin
Walsh
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Interleukin
Genetics
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617-281-8184
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ewalsh@ilgenetics.com
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Laura
Bailey
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University
of Michigan
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734-647-1848,
734-764-1552
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baileylm@umich.edu
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