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Posted by Ellen on 10:27:17 2004/08/05
(More lucky mice?)
United States Patent 6,770,272
Strom , et al. August 3, 2004
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Treatment of diabetes
Abstract
Disclosed are chimeric proteins having IL-10 fused to an enzymatically inactive polypeptide which increases the circulating half-life of IL-10. The chimeric polypeptides are useful for treating or preventing septic shock, inhibiting the development of Type I diabetes, and treating multiple myeloma in a patient.
STATEMENT AS TO FEDERALLY SPONSORED RESEARCH
This invention was made at least in part with funds from the Federal government, and the government therefore has certain rights in the invention.
....
Inhibition of the Development of Diabetes:
The chimeric IL-10 proteins of the invention are also useful for inhibiting the development of Type I diabetes in a patient. The following detailed example employs a well-known animal model, the non-obese diabetic (NOD) mouse. I have found that administration of IL-10/Fc to NOD mice completely prevents the development of diabetes in these mice. IL-10/Fc (1 .mu.g) was administered by intraperitoneal injection into 6 week old mice. When the mice reached 25 weeks of age, 80% of the control animals displayed signs of Type I diabetes, while none of the animals treated with IL-10/Fc appeared diabetic. Administration of IL-10/Fc to the mice was carried out every other day and then discontinued at 25 weeks of age. At 52 weeks of age, 84% of the animals which had been treated with IL-10/Fc continued to have normal glucose levels (i.e., they did not develop diabetes) despite the cessation of therapy. These data indicate that IL-10/Fc provides long-term protection against diabetes.
The chimeric IL-10 molecules of the invention can be administered to human patients inhibit the development of diabetes. The chimeric molecule can be formulated for intraperitoneal, intravenous, subcutaneous, or intramuscular administration in a pharmaceutically acceptable carrier (e.g., saline). Preferably the therapeutic composition is administered to the patient upon discover of anti-beta cell autoimmunity and/or subtle pre-diabetic changes in glucose metabolism (i.e. blunted early i.v. glucose tolerance test), and administration is repeated every other day or at a frequency as low as once per week. The preferred dosage of the chimeric protein can be determined by using standard techniques to monitor glucose levels, anti-beta cells autoantibody level, or abnormalities in glucose tolerance tests of the human being treated. A dosage of 1 .mu.g to 500 mg/kg body weight is sufficient. Generally, the preferred dosage is 1 to 200 .mu.g/kg; more preferably, the dosage is approximately 50 .mu.g/kg.
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