KineMed Evaluates The Mechanism Of Action For Colesevelam In Patients With Type 2 Diabetes

KineMed, Inc., a pathway-based drug discovery and development company, announced today that the company has received a grant from Daiichi Sankyo, Inc. to study the activity of colesevelam HCl, a bile acid sequestrant, in patients with type 2 diabetes. KineMed will apply its proprietary translational medicine technology, KineMarker(TM), to measure the effects of colesevelam HCl on multiple metabolic pathways in patients with type 2 diabetes. Published studies (1-4) have reported that colesevelam HCl can reduce the levels of hemoglobin A1C and fasting plasma glucose in subjects with type 2 diabetes. Based upon these study results, Daiichi Sankyo, Inc. announced in January 2007 the filing of a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) seeking a new indication for colesevelam HCl to improve glycemic control in patients with type 2 diabetes mellitus. In a recently initiated multi-center, investigator-sponsored clinical study, KineMed's technology will simultaneously measure the effects of colesevelam HCl in patients with type 2 diabetes on hepatic insulin sensitivity, gluconeogenesis, glucose absorption and lipid synthesis. A separate study will measure bile acid kinetics in healthy volunteers and subjects with type 2 diabetes. KineMed's KineMarker technology is designed to quickly demonstrate, preclinically and clinically, whether compounds are "on mechanism" or are acting upon specific metabolic pathways that are the basis for particular diseases. KineMed's technology measures the kinetics of these pathways using a stable isotope labeling technique and mass isotopomer distribution analysis (MIDA), allowing observation of treatment-induced changes in patients. David Fineman, President and CEO of KineMed, commented, "This investigator-initiated clinical study calls for KineMed to rapidly identify new uses for yet another late-stage or commercialized product by demonstrating on-mechanism therapeutic effect and dose-response in clinical studies. Direct application of our technology in this clinical setting further demonstrates the importance of insightful translational medicine in contemporary drug development." About KineMed, Inc. KineMed, Inc. ("KineMed" or the "Company") is a drug discovery and development company employing its proprietary translational medicine technology (AquaTag(TM) and KineMarker(TM)) to both identify active drug candidates preclinically and confirm their therapeutic activity and dose response in first-in-man studies. KineMed's technology expedites the drug development process and provides real-time insight into conditions including metabolic disorders, cancer, and diseases of inflammation and neurodegeneration. KineMed is working to develop drugs both on its own and with pharmaceutical collaborators in therapeutic focus areas where it can demonstrate functional modulation of specific biological pathways that mediate disease. The Company has multiple development programs with more than a dozen major pharmaceutical companies, including Bayer, Merck, Organon and Roche. For further information about KineMed, please visit:

(Author: http://www.kinemed.com)

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