Methods for Enhanced Somatostatin Immunogenicity in the Treatment of Obesity

• US 20130149332A1
• Filed: 02/19/2013
• Published: 06/13/2013
• Est. Priority Date: 06/25/2008
• Status: Abandoned Application

• Current Assignee: Braasch Biotech LLC
• Original Assignee: Braasch Biotech LLC
• Inventors: Haffer, Keith N., Larrick, James, Mendelsohn, Andrew R.
• Application Number:
  US13/770,118
• Publication Number:
  US 20130149332A1
• Time in Patent Office: Days
• US Class Current: 424/195.11
• CPC Class Codes: A61K 2039/55555 Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers
• CPC Class Codes: A61K 2039/55566 Emulsions, e.g. Freund's adjuvant, MF59
• CPC Class Codes: A61K 39/0005 Vertebrate antigens from snakes A61K39/38
• CPC Class Codes: A61K 39/0008 Antigens related to auto-immune diseases; Preparations to induce self-tolerance
• CPC Class Codes: A61K 39/39 characterised by the immunostimulating additives, e.g. chemical adjuvants
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• CPC Class Codes: A61P 3/04 Anorexiants; Antiobesity agents
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 37/00 Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 37/04 Immunostimulants
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 5/02 of the hypothalamic hormones, e.g. TRH, GnRH, CRH, GRH, somatostatin
• CPC Class Codes: A61P 5/04 for decreasing, blocking or antagonising the activity of the hypothalamic hormones
• CPC Class Codes: A61P 5/06 of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: C07K 14/655 Somatostatins
• CPC Class Codes: C07K 2319/00 Fusion polypeptide
• CPC Class Codes: C07K 2319/31 fusions, other than Fc, for prolonged plasma life, e.g. albumin
• CPC Class Codes: C12N 9/1033 Chloramphenicol O-acetyltransferase (2.3.1.28)

Abstract

Compositions and methods are provided for treatment growth hormone and/or insulin-like growth factor 1 deficiency in a patient in need of such treatment. Compositions and methods include novel vaccines that provide immunogenicity for somatostatin and result in the increased release of endogenously produced growth hormone and/or insulin-like growth factor 1.

Claims

1. A method for treating a growth hormone deficiency in a patient, the method comprising:

administering an immunogenic amount of a vaccine to the patient, the vaccine comprising (a) a chimeric polypeptide of somatostatin-14 attached to an inactivated chloramphenicol acetyl transferase (CAT) enzyme and (b) an adjuvant, wherein the administered vaccine results in an increase in growth hormone levels in the patient having the growth hormone deficiency.

2. The method of claim 1 wherein the vaccine comprises a chimeric polypeptide of somatostatin-14 functionally attached to a substantially inactivated CAT enzyme.

3. The method of claim 2 wherein the adjuvant comprises an effective amount of Carbopol 974P.

4. The method of claim 3 wherein the adjuvant further comprises squalene and non-animal origin Tween 80.

5. The method of claim 1 wherein the patient is an adult having growth deficiency.

6. The method of claim 1 wherein the patient is a child having growth deficiency.

7. The method of claim 1 wherein the patient being treated for a growth hormone deficiency has a mucosal disease.

8. The method of claim 1 wherein the patient being treated for a growth hormone deficiency has a cardiac disease.

9. The method of claim 1 wherein the patient being treated for a growth hormone deficiency is obese.

10. The method of claim 1 wherein the patient is an obese dog.

11. The method of claim 1 wherein the patient is an obese cat.

12. The method of claim 1 wherein the patient is a horse in need of cartilage repair.

13. A method for treating an insulin-like growth factor 1 deficiency in a patient, the method comprising:

administering an immunogenic amount of a vaccine to the patient, the vaccine comprising a somatostatin-based antigen and an adjuvant, wherein the administered vaccine results in an increase in insulin-like growth factor 1 levels in the patient having the insulin-like growth factor 1 deficiency.

14. The method of claim 13 wherein the patient being treated for insulin-like growth factor 1 deficiency has type 1 or type 2 diabetes.

15. The method of claim 13 wherein the patient being treated for insulin-like growth factor 1 deficiency has a stress disorder.

16. The method of claim 13 wherein the patient being treated for insulin-like growth factor 1 deficiency has cardiac disease.

17. An adjuvant for use in a vaccine for treating a vertebrate, the adjuvant comprising:

a Carbopol 974P base;

a squalene base; and

an arabinogalactan solution;

wherein the adjuvant acts as a carrier for a somatostatin-based antigen for treatment of human growth hormone or insulin-like growth factor 1 deficiency in the vertebrate.

18. The adjuvant of claim 17 wherein the squalene base is a combination of squalene, non-animal origin Tween 80 and Span 85.

19. The adjuvant of claim 17 wherein the somatostatin-based antigen is somatostatin-14 linked to a substantially inactivated CAT enzyme.

20. The adjuvant of claim 17 wherein the inactivated CAT enzyme has one or more wild type histidine residues replaced with alanine, glycine or other like amino acid.

21. A vaccine for treatment of a patient having a growth hormone and/or insulin-like growth factor 1 deficiency, the vaccine comprising:

an immunogenic amount of somatostatin-based antigen; and

an adjuvant comprising at least Carbopol 974P, squalene and arabinogalactan.

22. The vaccine of claim 21 wherein the somatostatin-based antigen is somatostatin-14 attached to an inactivated CAT enzyme.

23. The vaccine of claim 22 wherein the inactivated CAT enzyme has one or more wild type histidine residues replaced with alanine, glycine or other like amino acid.