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Claims for Patent: 9,060,992

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Claims for Patent: 9,060,992

Title:Treatment of short bowel syndrome patients with colon-in-continuity
Abstract: Intestinal absorption is enhanced in short bowel syndrome patients presenting with colon-in-continuity by treatment with a GLP-2 receptor agonist, such as teduglutide.
Inventor(s): Sanguinetti; Elizabeth Lemaire (Salt Lake City, UT), Marriott; Thomas B. (Sandy, UT), Lopansri; Jennifer (Salt Lake City, UT), Blosch; Consuelo Maria (Mercer Island, WA)
Assignee: NPS Pharmaceuticals, Inc. (Bedminster, NJ)
Application Number:12/938,117
Patent Claims: 1. A method for enhancing intestinal absorption in a patient with short bowel syndrome with colon-in-continuity with remnant small intestine, wherein the patient retains colon sufficient to produce at least about 10% of endogenous GLP-2 levels produced by a healthy individual in a fed state, comprising the step of administering to said patient a GLP-2 receptor agonist using a dosing regimen effective to enhance intestinal absorption, wherein said GLP-2 receptor agonist is selected from the group consisting of a GLP-2 peptide, a GLP-2 analog, a derivatized GLP-2 peptide or a derivatized GLP-2 analog.

2. The method according to claim 1, wherein said enhancement of intestinal absorption is an increase in at least one of a wet weight absorption compared to a baseline wet weight absorption and/or an energy absorption compared to a baseline energy absorption.

3. The method according to claim 2, wherein said patient has at least 25% colon-in-continuity with remnant small intestine.

4. The method according to claim 3, wherein said patient has at least 50% colon-in-continuity with remnant small intestine.

5. The method according to claim 4, wherein said patient has at least 75% colon-in-continuity with remnant small intestine.

6. The method according to claim 2, wherein said patient has colon sufficient to produce endogenous GLP-2 plasma levels of at least 5pmol/L in the fed state.

7. The method according to claim 6, wherein said patient has colon sufficient to produce endogenous GLP-2 plasma levels of at least 10pmol/L in the fed state.

8. The method according to claim 2, wherein said remnant small intestine has a length of at least 25 cm.

9. The method according to claim 8, wherein said remnant small intestine has a length of at least 50 cm.

10. The method according to claim 2, wherein said dosing regimen comprises daily administration of said GLP-2 receptor agonist.

11. The method according to claim 2, wherein said dosing regimen comprises administration of said GLP-2 receptor agonist over a period of at least 21 days.

12. The method according to claim 2, wherein said GLP-2 receptor agonist is a mammalian GLP-2.

13. The method according to claim 12, wherein said GLP-2 receptor agonist is human GLP-2.

14. The method according to claim 2, wherein said GLP-2 receptor agonist is a GLP-2 analog.

15. The method according to claim 14, wherein said GLP-2 receptor agonist is a human GLP-2 analog.

16. The method according to claim 15, wherein said GLP-2 receptor agonist is [Gly2]hGLP-2.

17. The method according to claim 10, wherein said GLP-2 receptor agonist is administered at a daily dose of from 5 to 500 .mu.g/kg/day.

18. The method according to claim 1, wherein the patient's short bowel syndrome is secondary to at least one of: Crohn's disease, vascular ischemic disease, mesenteric infarction, malrotation, volvulous, trauma, injury, a congenital anomaly, or a stricture.

19. The method according to claim 18, wherein the patient's short bowel syndrome is secondary to Crohn's disease.

20. The method according to claim 18, wherein the patient's short bowel syndrome is secondary to a stricture.

21. The method according to claim 18, wherein the patient's short bowel syndrome is secondary to mesenteric infarction.

22. The method according to claim 18, wherein the patient's short bowel syndrome is secondary to volvulous.

23. The method according to claim 20, wherein the patient's short bowel syndrome is secondary to injury.

24. The method according to claim 1, wherein the patient produces at least about 20%, 30%, 40%, or 50% of the endogenous GLP-2 plasma levels produced by a healthy individual in the fed state.

25. The method according to claim 1, wherein the patient produces about 100% of the endogenous GLP-2 plasma levels produced by a healthy individual in the fed state.

26. A method according to claim 1, wherein the patient produces at least about 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, or 70 pmol/L endogenous GLP-2 plasma levels in the fed state.
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