US2004002113A1PendingUtilityA1

Detection and treatment methods for type I diabetes

Assignee: DARTMOUTH COLLEGEPriority: Jul 8, 1994Filed: Dec 17, 2002Published: Jan 1, 2004

Est. expiryJul 8, 2014(expired)· nominal 20-yr term from priority

A61P 9/00A61P 3/08A61P 37/00A61P 7/06A61P 29/00A61P 27/16A61P 27/02A61P 15/00C07K 14/62A61P 1/00C07K 14/70539Y10S530/868Y10S530/806A61P 17/00A61K 38/00A61P 13/02G01N 2333/62G01N 33/5091

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Claims

Abstract

Proinsulin peptide compounds that modulate an immunological response by T cells of Type I diabetic subjects are disclosed. The proinsulin peptide compounds of the invention are preferably derived from a region of proinsulin that spans the junction between the B chain and C peptide of proinsulin. Pharmaceutical compositions comprising the proinsulin peptide compounds are also disclosed. An immunological response to a proinsulin peptide compound of the invention can be used as an indicator of Type I diabetes in a subject. Accordingly, the invention provides diagnostic assays for Type I diabetes using the proinsulin peptide compounds. Methods for inhibiting the development or progression of Type I diabetes in a subject by administering a proinsulin peptide compound are also disclosed.

Claims

exact text as granted — not AI-modified

1 . A method for detecting an indicator of Type I diabetes in a subject, comprising
a) obtaining a biological sample from the subject; b) contacting the sample with a proinsulin peptide compound which stimulates an immunological response by T cells of Type I diabetic subjects; and c) detecting an immunological activity in the sample against the proinsulin peptide compound as an indicator of Type I diabetes in the subject.

2 . The method of claim 1 , wherein the compound is identical or substantially similar to a region of proinsulin that spans the junction between the B chain and the C peptide of proinsulin.

3 . The method of claim 1 , wherein the compound is derived from human proinsulin.

4 . The method of claim 1 , wherein the compound comprises an amino acid sequence comprising the formula:

Y 1 -(Xaa)n-(Ser/Thr)-Pro-Lys-(Ser/Thr)-Arg-Arg-

(Glu/Asp)-(Zaa)m-Y 2

wherein Xaa and Zaa, which may or may not be present, represent amino acid residues, n and m are integers from 1 to 15, Y 1 is hydrogen or an amino-derivative group and Y 2 is hydrogen or a carboxy-derivative group.

5 . The method of claim 4 , wherein the compound is 10-35 amino acids in length.

6 . The method of claim 4 , wherein the compound is 10-20 amino acids in length.

7 . The method of claim 4 , wherein the compound is 12-17 amino acids in length.

8 . The method of claim 4 , wherein the compound comprises an amino acid sequence:

Y 1 -Gly-Phe-Phe-Tyr-(Ser/Thr)-Pro-Lys-(Ser/Thr)-

Arg-Arg-(Glu/Asp)-Ala-Glu-(Glu/Asp)-Leu-Gln-Val-

Gly-Y 2

9 . The method of claim 1 , wherein the detected immunological activity is a T cell response to the proinsulin peptide compound.

10 . The method of claim 9 , wherein the T cell response is proliferation.

11 . The method of claim 9 , wherein the T cell response is cytokine production.

12 . The method of claim 1 , wherein the detected immunological activity is antibody binding to the proinsulin peptide compound.

13 . A method for inhibiting the development or progression of Type I diabetes in subject, comprising administering to the subject a proinsulin peptide compound which modulates an immunological response by T cells of Type I diabetic subjects.

14 . The method of claim 13 , wherein the compound is identical or substantially similar to a region of proinsulin that spans the junction between the B chain and the C peptide of proinsulin.

15 . The method of claim 13 , wherein the agent is a compound derived from human proinsulin.

16 . The method of claim 13 , wherein the compound comprises an amino acid sequence comprising the formula:

Y 1 -(Xaa)n-(Ser/Thr)-Pro-Lys-(Ser/Thr)-Arg-Arg-

(Glu/Asp)-(Zaa)m-Y 2

17 . The method of claim 16 , wherein the compound is 10-35 amino acids in length.

18 . The method of claim 16 , wherein the compound is 10-20 amino acids in length.

19 . The method of claim 16 , wherein the compound is 12-17 amino acids in length.

20 . The method of claim 16 , wherein the compound comprises an amino acid sequence:

Y 1 -Gly-Phe-Phe-Tyr-(Ser/Thr)-Pro-Lys-(Ser/Thr)-

Arg-Arg-(Glu/Asp)-Ala-Glu-(Glu/Asp)-Leu-Gln-Val-

Gly-Y 2

21 . The method of claim 13 , wherein a tolerogenic amount of the compound is administered to the subject.

22 . The method of claim 14 , wherein the compound comprises a modified form of a proinsulin peptide that spans the junction between the B chain and the C peptide of proinsulin.

23 . The method of claim 13 , wherein the compound is administered in a pharmaceutically acceptable carrier.

24 . The method of claim 13 , wherein the compound is administered intravenously.

25 . The method of claim 13 , wherein the compound is administered subcutaneously.

26 . The method of claim 13 , wherein the compound is administered orally.

27 . The method of claim 13 , wherein the compound is administered intramuscularly intraperitoneally.

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