IP Library Granted Patent US 8,058,234
Granted Patent B2
US 8,058,234 · App. 12/542,620 · Granted Nov 15, 2011

Lactoferrin as an agent in the prevention of organ transplant rejection and graft-versus-host-disease

Assignee: Agennix Incorporated
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Quick Facts
Patent No.
US 8,058,234
App. No.
12/542,620
Granted
Nov 15, 2011
Kind
B2
Abstract

The present invention relates to methods of using lactoferrin (LF) to treat, prevent or reduce the incidence of organ transplant rejection and graft-versus-host-disease. More particularly, the present invention relates to methods of reducing an immune response against miss-matched transplanted organs such as kidney, heart, lung, liver, pancreas and stem cells by administering a composition of lactoferrin to the recipient patients. In addition, this invention relates to the treatment of bone marrow transplant (BMT) donors with lactoferrin to attenuate the development of graft-versus-host-disease in the recipients. Moreover, this invention relates to the treatment of xenograft organ donors with lactoferrin to attenuate the development of graft rejection in the recipients.

Claims (29)

1. A method of treating tissue or organ transplant rejection in a recipient comprising the step of parenterally administering to the recipient an effective amount of a lactoferrin composition to attenuate the tissue or organ transplant rejection.

2. The method of claim 1 , wherein said lactoferrin composition reduces allogeneic immune responses in the recipient.

3. The method of claim 1 , wherein the tissue is bone marrow or peripheral stem cells.

4. The method of claim 1 , wherein the organ is kidney, heart, lung, liver, or pancreas.

5. The method of claim 1 , wherein said lactoferrin composition regulates T cell responses by inducing transplant tolerance in the recipient.

6. The method of claim 1 , wherein said lactoferrin composition is dispersed in a pharmaceutically acceptable carrier.

7. The method of claim 1 , wherein said lactoferrin is mammalian lactoferrin.

8. The method of claim 7 , wherein said lactoferrin is human lactoferrin or bovine lactoferrin.

9. The method of claim 1 , wherein said lactoferrin is recombinant lactoferrin.

10. The method of claim 1 , further comprising administering an antacid in conjunction with said lactoferrin composition.

11. The method of claim 1 , further comprising administering the lactoferrin in a delayed release formulation.

12. The method of claim 1 , wherein the amount of the lactoferrin composition that is administered is about 1 mg to about 20 g per day.

13. The method of claim 1 , wherein the amount of the lactoferrin composition that is administered is about 0.1 g to about 5 g per day.

14. The method of claim 1 , wherein said lactoferrin stimulates interleukin-18 or MIP-3-alpha in the gastrointestinal tract.

15. The method of claim 1 , wherein said lactoferrin regulates the activity of immune cells.

16. The method of claim 15 , wherein the immune cells are B and T lymphocytes, antigen-presenting cells, natural killer cells, macrophages and granulocytes.

17. The method of claim 16 , wherein the T lymphocytes are selected from the group consisting of CD4+/CD3+, CD8+/CD3+ cells and NK-T cells.

18. The method of claim 1 , wherein said lactoferrin regulates the production or activity of pro-inflammatory cytokines.

19. The method of claim 1 , further comprising administering a metal chelator dispersed in a pharmaceutically acceptable carrier.

20. The method of claim 19 , wherein the metal chelator is ethylenediaminoetetracacetic acid (EDTA) or [etheylenebis(oxyethylenenitrilo)] tetraacetic acid (EGTA).

21. The method of claim 20 , wherein the metal chelator is EDTA.

22. The method of claim 21 , wherein the amount of EDTA that is administered is about 1 ng to about 1 g per day.

23. The method of claim 1 , further comprising administering an immunosuppressive agent, anti-rejection agent or anti-GVHD therapy in combination with the lactoferrin composition.

24. The method of claim 23 , wherein the immunosupressive agent is selected from the group consisting of cyclosporine, prednisone, azathioprine, tacrolimus and mycophenolate mofetil.

25. A method of modulating the immune response against an organ or tissue transplant in a recipient comprising the step of parenterally administering to the recipient an effective amount of a lactoferrin composition to modulate the response against the organ or tissue transplant.

26. A method of treating graft-versus-host-disease in a recipient comprising the step of parenterally administering to the recipient an effective amount of a lactoferrin composition to attenuate the graft-versus-host-disease in the recipient.

27. The method of claim 26 further comprising treating ex vivo the donor organ or tissue with the lactoferrin composition.

28. The method of claim 27 , wherein the tissue is a stem cell.

29. The method of claim 27 , wherein the tissue is bone marrow or peripheral stem cells.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 5, 2011
From: VARADHACHARY, ATUL; PERICLE, FEDERICA
To: AGENNIX INCORPORATED
Reel/Frame 027018/0070 →
Continuity (4)
Division 10732429 · Dec 10, 2003
Provisional Application 60432113 · Dec 10, 2002
Provisional Application 60498338 · Aug 27, 2003
Related Publication 20090318334A1 · Dec 24, 2009