Our company will develop and characterize diagnostic reagents and assays for diabetes management through development of monclonal antibodies to the peptide hormone, amylin. Amylin is a newly discovered peptide hormone that is active in the control of glucose metabolism and the ability to accurately measure peptide levels will be key to understanding the role that the hormone plays in the disease process of type I and type II diabetes.In Phase II we willi) use monoclonal antibodies developed m Phase I to develop a sandwich assay for amylin capable of direct measurement of human amylin at physiological concentrations (3pM) from small volumes of plasma.ii) Use this assay to complete targeted clinical research studies and establish how amylin measurements could be used to diagnose and manage diabetic patients.iii) Purify and characterize the immunoreactive material from plasma measured by the two site assay. Define if the assay measures only intact amylin or if altered forms of the molecule, e.e. proamylin, amylin fragments are measured in the assay.iv) Determine whether amylin circulates in a protein-bound form and if a specific amylin binding protein can be identified.Awardee's statement of the potential commercial applications of the research:The Phase II effort described will produce a validated, commercially viable immunodiagnostic test and information from pilot clinical studies on the human biology of the hormone, amylin, and its relationship to type I and type II diabetes. The combination of these two goals is expected to lead to the use of an amylin diagnostic product for: I ) detection of insulin resistance as a risk factor for diabetes, 2) prognosis for type II diabetes, 3) monitoring Herapy for type II diabetes, 4) diagnosis of gestational diabetes, and 5) monitoring amylin replacement therapy in type I diabetes.National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
