WALTHAM, Mass., July 16 /PRNewswire-FirstCall/ -- Interleukin Genetics, Inc. announced today that it has completed patient enrollment in clinical studies in Japan and China as part of its preparation for the planned launch of genetic tests in Asian markets in 2009.
In collaboration with investigators at Tongji Medical College in Wuhan, China, 1,300 subjects who have cardiovascular disease or are healthy controls have been enrolled in the clinical study. The other study, in collaboration with the New Medical Research System Clinic in Tokyo, completed enrollment of 400 subjects ahead of schedule. The study in Tokyo is focused on genetic variations, bone loss and osteoporosis in post-menopausal women in Japan. Interleukin expects completion of data collection for both studies by the end of August.
“Interleukin Genetics expects to provide multiple genetic tests for commercial launches in Asia in the next few years through our global partnership with Alticor, or possibly with other partners through more traditional medical channels,” said Ken Kornman, Chief Scientific Officer. “As Interleukin did in North America, we will provide tests that have been scientifically validated and that provide important information to help individuals live healthier lives for longer periods. The studies in Japan and China will help Interleukin’s scientists to better understand how genetic variations that predict increased risk for heart attacks and osteoporosis may be influenced by dietary and environmental factors in different populations and help us successfully introduce our genetic tests into these important markets.”
About the Studies
Interleukin Genetics is investigating the role of genetics in determining individual risks for early cardiovascular disease events and for bone loss and related fractures in specific populations.
Variations in the interleukin-1 (IL-1) gene family have been shown to be associated with over-expression of key inflammatory mediators, such as C-reactive protein, and with increased risk for early first heart attacks in Caucasians. Using its proprietary IL-1 technology, Interleukin is now collaborating with Tongji Medical College to study multiple genetic links to risk for early myocardial infarction (MI) in a Chinese population. This study of 1,300 individuals will focus on multiple candidate genes and their relationship to levels of inflammatory mediators and to risk for early MI. The cardiovascular disease genetics study in China is under the direction of Dr. Tangchun Wu at Tongji Medical College, Huazhong University of Science and Technology in Wuhan, China.
Variations in the interleukin-1 (IL-1) gene family have also been shown to be associated with increased bone resorption and with vertebral fracture risk in postmenopausal Caucasian women. Interleukin is now collaborating with New Medical Research System Clinic to study IL-1 and other genetic factors that may lead to accelerated bone breakdown in Japanese women during the early years after menopause, the period of greatest bone loss. Key objectives of this 400 patient study include testing the hypothesis that, in postmenopausal Japanese women who are not on hormone replacement therapy, common variations in IL-1 genes are associated with increased bone turnover leading to net bone loss, as demonstrated by elevated markers of bone metabolism, primarily for bone breakdown. The osteoporosis study in Japan is under the direction of Dr. Masataka Karube, M.D., New Medical Research Systems Clinic, and Dr. Osamu Chaki, M.D. Ph.D., Yokohama City University Medical Centre, Yokohoma, Japan, who is the Medical Advisor.
Cardiovascular Disease
Cardiovascular diseases are the number one cause of deaths in the U.S., with approximately 36% of all deaths attributable to cardiovascular disease. Although heart disease is often considered a problem of older individuals, it is well established that the disease starts in adolescence, and the American Heart Association reports that there are more than 140,000 deaths each year due to heart disease in individuals under the age of 65. Approximately 1.2 million Americans have a new or recurrent heart attack each year. In spite of great public awareness and efforts to reduce risk factors, such as smoking, high cholesterol, high blood pressure, and diabetes, heart disease remains a major individual and public health problem. In addition, we now know that most first heart attacks occur in individuals who do not have high cholesterol, and one-fifth of all cardiovascular events are in individuals without any standard risk factor. There is therefore a great need to develop better tools to identify individuals who are at increased risk for first heart attacks.
Although heart disease has historically been low in Asian countries compared to Western populations, the disease in Japan, Korea, and China is rapidly changing with changes in diet and shifts to more urban environments. This is evident in Korea where as of the year 2000, 84% of the population lived in urban areas and the incidence of coronary artery disease increased over 6-fold from 1981 to 1994.
Osteoporosis and Vertebral Fracture
The greatest increase in osteoporosis in the future is projected to be in Asia and in Latin America. Osteoporosis has been referred to as a “silent disease” because bone loss occurs without symptoms, and for many people, the first indication that they have the disease is when a fracture occurs. According to the International Osteoporosis Foundation, approximately 75 million people in the United States, Europe and Japan have osteoporosis, a number that is expected to double in the next 50 years. It is further estimated that another 225 million individuals have low bone mass, or osteopenia. The disease affects both men and women over 50 years of age and of all ethnic backgrounds, although in the U.S. women represent 80% of the disease population, and the disease is most common among non-Hispanic white and Asian women.
Vertebral, or spine fractures, often occur without any symptoms and only become evident when the individual notices a loss of height, develops the “dowager’s hump” appearance, or starts to experience pain resulting from compression of vertebrae. It is well established that osteoporosis significantly increases the risk of vertebral, hip, wrist and other fractures -- over 1.5 million fractures in the U.S. annually - with 1 in 2 women and 1 in 4 men over 50 suffering an osteoporosis-related fracture during her/his lifetime. In 2002, costs directly associated with osteoporosis-related hip fractures were estimated to be $18 billion.
About Interleukin
Interleukin Genetics is a biotechnology company focused on developing, acquiring, and commercializing personalized health products. The company uses functional genomics to help in the development of risk assessment tests, pharmacogenetic tests, nutritional and therapeutic products based on the genetic variations in people. Interleukin Genetics has commercialized genetic tests for periodontal disease risk assessment, cardiovascular risk assessment, and general nutrition assessment. In addition, through its the Alan James Group subsidiary, the company sells its nutraceutical brands, including Ginkoba(R), Ginsana(R), and Venastat(R) through the nation’s largest food, drug and mass retailers. Interleukin’s current development programs focus on osteoporosis and weight management genetic risk assessment tests, as well as its new proprietary OTCeutical(R) products for distribution through the Alan James Group. Interleukin expects that these programs will also lead to the personalized selection of nutritional and therapeutic products, and provide consumers and healthcare professionals with better preventative product alternatives. For more information about Interleukin and its ongoing programs, please visit http://www.ilgenetics.com.
Certain statements contained herein are “forward-looking” statements including statements regarding our ability to develop diagnostic, personalized nutritional and therapeutic products to prevent or treat diseases of inflammation and other genetic variations, our ability to screen nutritional compounds for their effects on inflammatory responses and other genetic variations, given specific genetic patterns and our ability to make progress in advancing our core technologies. 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 our products, the risk of technology and product obsolescence, delays in product development, our ability to identify appropriate commercial partners and enter into favorable arrangements with them, the performance of our commercial partners, the availability of adequate capital, the actions of our competitors and other competitive risks, and those risks and uncertainties described in our annual report on Form 10-K for the year ended December 31, 2006, as amended, filed with the Securities and Exchange Commission, our quarterly reports on Form 10-Q and other filings made by us with the Securities and Exchange Commission. We disclaim any obligation or intention to update these forward-looking statements.
Interleukin Genetics, Inc.
CONTACT: Paul Voegelin of Interleukin Genetics, +1-781-398-0700; JJ Rissiof Weber Shandwick, +1-212-445-8224; or Rich Tauberman of FinancialRelations Board, +1-201-964-2408
Web site: http://www.ilgenetics.com/
