Daiichi Fine Chemical Co., Ltd. of Japan today announced that it has selected world-renowned Cardiologist Dr. John A. Rumberger and the Contract Research Division of KGK Synergize Inc. to launch a new clinical trial to investigate the effect of pantethine as a dietary supplement for lipid management and the reduction of cardiovascular risk factors in the North American population.
The randomized, double-blind placebo controlled study will be conducted in two North American locations by Ontario-based KGK under the direction of Dr. Dale Wilson, KGK medical director and principal investigator for the study.
An internationally recognized specialist in preventive cardiology, Rumberger currently is director of cardiac imaging at the Princeton (N.J.) Longevity Center, clinical professor of medicine at Ohio State University and former professor of medicine at the Mayo Clinic. He also is author of ‘The Way Diet’ which provides information about optimal diet, supplementation, exercise and stress management in preventing heart disease. He will offer consultation on protocol design and comment on the findings of the clinical trial.
The study design process started last month, study subjects at low to moderate risk levels of cardiovascular disease will be treated over a 16-week period, and results are expected by the third quarter of 2009.
Daiichi Fine Chemical, sponsor of the study, is the world’s leading supplier of pantothenic acid (vitamin B5) and its derivatives, including pantethine, marketed under the brand name Pantesin®. Sold in Japan for more than 35 years, Pantesin has been available as a dietary supplement in the United States since 1992. Although Pantesin’s effectiveness in safely lowering cholesterol levels has been documented in more than 30 clinical studies, the new study will be the most expansive ever conducted using North American subjects.
“Maintaining an optimal balance among LDL, HDL, and triglycerides is more important than simply lowering cholesterol and key to cardiovascular health,” Rumberger said. “A low-fat and modified carbohydrate diet, exercise and regular consumption of dietary supplements formulated with scientifically proven, high quality ingredients can help individuals achieve a healthy blood lipid profile.
“A large body of research points to Pantethine’s effectiveness in Asian and Western European populations, where oral administration of Pantethine has consistently shown an ability to favorably impact a variety of risk factors in people with hypercholesterolemia, arteriosclerosis and diabetes. The aim of the current trial is to confirm these results in a clinical setting in North America where cardiovascular disease is the leading cause of death.”
Founded in 1997 by three scientists associated with the Centre for Human Nutrition at The University of Western Ontario, KGK maintains a global reputation for uncompromising science focused on nutraceutical, biotechnology and pharmaceutical product research.
“Our team of research experts is devoted to discovering the unique properties inherent in natural products that enhance and promote a healthy lifestyle,” said KGK President and Chief Executive Officer Najla Guthrie. “Our in-house lab and clinic along with our location at a leading scientific and medical research center ensure timely and conclusive research results overseen by leading physicians in the area of study.”
Daiichi Fine Chemical is a global leader in researching the use of pantethine. By commissioning this new clinical trial, Daiichi signals its continued support of research that takes into account lifestyle changes and breakthrough discoveries that may impact the role Pantethine can play in enhancing cardiovascular health.
About Daiichi Fine Chemical
Daiichi Fine Chemical Co.Ltd., is the world’s largest supplier of the cholesterol-management agent pantethine, a derivative of vitamin B5, which it markets under the brand name Pantesin®. Daiichi Fine Chemical has a reputation of strict pharmaceutical GMP standards at the firm’s vertically integrated operation in Japan which are applied to Pantesin®. Kyowa Hakko Kogyo Co., Ltd., Japan acquired all shares of Daiichi Fine Chemical from Daiichi-Sankyo Co., Ltd. in 2007. As a wholly owned subsidiary in Kyowa’s bio-chemical business, Daiichi Fine Chemical continues to supply vitamin B5 of highest quality standards. For more information visit www.daiichi-fcj.co.jp
About KGK Synergize, Inc.
Created in 1997 by three experienced nutritional scientists from University of Western Ontario to facilitate commercialization of research and development findings, KGK Synergize, Inc. provides contract research services to health nutrition, biotechnology and pharmaceutical industries. In addition to providing contract research services, KGK’s Product Development Division brings new and innovative natural health products to the point where they are ready to be manufactured and marketed. For more information visit www.kgksynergize.com
About Dr. John A. Rumberger, PhD, MD, FACC
John A. Rumberger, PhD, MD, is among the world’s leading authorities on cardiac and vascular imaging using EBT and CT Scanning and specializes in preventive cardiology and cardiac and cardiovascular imaging. He currently is director of cardiac imaging at the Princeton Longevity Center (PLC), Princeton, N.J., and clinical professor of medicine at Ohio State University. He is a former professor of medicine at the Mayo Clinic and Foundation, Rochester, Minn., and a diplomat of both the American Board of Internal Medicine and the American Board of Cardiovascular Diseases. During his more than 20-year career as a clinician, educator and researcher, Dr. Rumberger has published over 200 peer-reviewed articles, 200 abstracts, 40 book chapters and two books dealing with a variety of applications for cardiac CT. He is a worldwide recognized authority on electron beam and multi-detector (MDCT) for applications to cardiovascular disease and in development of practice guidelines for interpretation in patients. He has lectured worldwide on EBT, early heart disease diagnosis, and wellness. He is a Fellow of the American College of Cardiology and a member of the American Heart Association, the American Federation for Clinical Research, and a Founding Member and Incorporator of the Society of Cardiovascular Computed Tomography. Dr. Rumberger is a past- Chairman of the AHA Committee on Cardiovascular Imaging and Intervention, Council of Cardiovascular Radiology and is the only clinical cardiologist to hold this position. He continues his interest in early diagnosis of preventable diseases and continues research and publication as well as conducting numerous physician educational seminars in the use of Cardiac CT. He received his doctorate in engineering and applied mathematics from The Ohio State University in 1976 and graduated from the University of Miami School of Medicine in 1978.