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October 19, 2000 Company Press Release Galileo Laboratories Initiates Type 2 Diabetes Clinical StudyStudy Targets Complications and Incorporates Gene Profiling & Wireless TechnologySanta Clara, CA, October 19, 2000 – Galileo Laboratories, Inc. announced today the initiation of clinical studies of NIS215 in type 2 diabetics. The single-center trial will evaluate improvements of end-organ function achieved by targeting the systemic inflammation and oxidative stress component of diabetes. Primary study endpoints include improvements in glucose control and renal function. Secondary study endpoints are reductions in existing and novel serum and urine biomarkers of systemic inflammation and metabolic stress response. The study uses both gene profiling and wireless internet technologies. “Given the diversity and known genetic variation associated with diabetes, the use of gene profiling will guide the identification of responders and non-responders in subgroup analysis,” said Stephen Phinney, MD, PhD, Vice President, Galileo Laboratories. “Furthermore, enrollees will actively participate using internet-enabled cell phones. This technology will be evaluated as a means to enhance participant compliance and to gather valuable real-time data from study participants through the course of their daily activities.” An estimated 16 million Americans are diagnosed with either type 1 (juvenile-onset) or the more common type 2 (adult-onset) diabetes. Diabetes affects nearly every major organ system and crosses race, gender, and socioeconomic boundaries. Diabetes is a major contributor to kidney failure and blindness; it is the leading risk factor for stroke and heart disease; it shortens life expectancy by up to 15 years; and diabetes is the sixth leading cause of death in the United States. The economic consequences of diabetes parallel the human toll. Annual U.S. healthcare expenditures on diabetics exceed $100 billion. Of note, 25% of all Medicare beneficiaries are diabetic. As the population ages and the prevalence of obesity continues to increase, the number of diabetics continues to escalate dramatically. While nutrition therapy is a proven first line approach to glucose control in diabetes management, less understood is the contribution of depleted diet-derived micronutrients to mitigating the systemic inflammatory complications of the disease. Recognizing the need to expand existing efforts and develop new approaches to the treatment and prevention of complications of diabetes, the Congressionally established Diabetes Research Working Group, in its strategic plan for NIH funding, recommended that Congress expand research funding in multiple areas including metabolic profiling and address therapies that mitigate secondary complications resulting from diabetes. Through targeting metabolic profiling and employing a rationale discovery algorithm to identify depleted beneficial micronutrients, Galileo is developing safe and effective products to assist diabetics and their physicians in managing the harmful complications of diabetes. About Galileo LaboratoriesGalileo Laboratories is focused on discovering and developing pharmaceutical and nutritional products to treat and prevent oxidative and metabolic stress associated with chronic conditions such as cardiovascular disease and diabetes. The company has developed proprietary cell-based models of human metabolism that enable the discovery of pharmaceutical and nutritional leads. The company has agreements with Pfizer/Warner-Lambert and Procter & Gamble. ContactPeter
Leighton, Vice President Marketing
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