Use of GLP-2 and related compounds for the treatment, prevention, diagnosis, and prognosis of bone-related disorders and calcium homeostasis related syndromes

• US 7,371,721 B2
• Filed: 01/14/2005
• Issued: 05/13/2008
• Est. Priority Date: 09/18/2000
• Status: Expired due to Fees

• Current Assignee: Sanos Bioscience A/S (C.C. Consulting A/S)
• Original Assignee: Sanos Bioscience A/S (C.C. Consulting A/S)
• Inventors: Holst, Jens Juul, Henriksen, Dennis Bang
• Primary Examiner(s): Gupta; Anish
• Application Number:
  US11/035,826
• Publication Number:
  US 20050282749A1
• Time in Patent Office: 1,215 Days
• Field of Search: None
• US Class Current: 514/11.7
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 38/26 Glucagons
• CPC Class Codes: A61K 38/29 Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides

Abstract

The present invention relates to methods for prevention and treatment of bone-related disorders and calcium homeostasis related syndromes using a GLP-2 molecule or GLP-2 activator either alone or in combination with another therapeutic. The present invention also encompasses methods of diagnosing or monitoring the progression of a disorder. The invention also encompasses methods of monitoring the effectiveness of treatment of the invention.

Claims

1. A therapeutic composition comprising

a) a first active component which promotes bone formation and promotes bone resorption;

and

b) a second active component which is a GLP-2, or an analogue or derivative or mimic of GLP-2 having the ability to bind and activate a GLP-2 receptor, or is a GLP-2 receptor agonist.

2. A composition as claimed in claim 1, comprising as component (a) a PTH receptor binding ligand.

3. A composition as claimed in claim 2, wherein the PTH receptor binding ligand is a PTH, an active fragment of PTH, PTHrP, an active fragment of PTHrP, or is an analogue or derivative of any one of said ligands having the ability to bind and activate a PTH receptor.

4. A composition as claimed in claim 2, wherein component (a) is a PTH-1 receptor binding ligand.

5. A composition as claimed in claim 2, wherein said component (a) is also a PTH -2 receptor activating ligand.

6. A composition as claimed in claim 2, wherein said component (a) is not an activator for the PTH-2 receptor.

7. A composition as claimed in claim 2, wherein component (a) is a full length PTH or is a C-terminal truncated PTH, optionally modified from a natural sequence by substitution of one or more amino acids.

8. A composition as claimed in claim 7, wherein component (a) is a full length PTH or an N-terminal fragment containing at least the first 31 amino acid residues of PTH, optionally modified from a natural sequence by substitution of one or more amino acids.

9. A composition as claimed in claim 8, wherein component (a) is [Leu(27)]-cyclo(Glu(22)-Lys(26))-hPTH-(1-31)NH(2).

10. A composition as claimed in claim 7, wherein said component (a) is hPTH (1-84), hPTH (1-37), hPTH (1-36), hPTH (1-34), hPTH (1-31), or a cyclic derivative of any of the foregoing.

11. A composition as claimed in claim 2, wherein said component (a) is a PTH (1-9) fragment, optionally containing substitutions of natural or unnatural amino acids whilst maintaining PTH1 receptor signal activation activity and conjugated to an effective PTH1 receptor binding moiety.

12. A composition as claimed in claim 2, wherein said component (a) is full length PTHrP or is a C-terminal truncated PTHrP, optionally modified from a natural sequence by substitution of one or more amino acids.

13. A composition as claimed in claim 12, wherein said component (a) is a PTHrP (1-40), optionally modified from a natural sequence by substitution of one or more amino acids.

14. A composition as claimed in claim 1, wherein said component (b) is GLP-2 (1-34).

15. A composition as claimed in claim 8, wherein said component (b) is GLP-2 (1-34).

16. A composition as claimed in claim 1, wherein said composition is formulated for administration by injection.