Method for the treatment or prevention of infection-related immune conditions using a composition comprising IgM

Patent metadata

Field	Value
Publication number	US-9913903-B2
Application number	US-201615147226-A
Country	US
Kind code	B2
Filing date	May 5, 2016
Priority date	Aug 6, 2015
Publication date	Mar 13, 2018
Grant date	Mar 13, 2018

Abstract

Embodiments of the present invention provide methods for the treatment or prevention of infection-related immune conditions using compositions comprising IgM.

First claim

What is claimed is:

1. A method for the treatment of immune complications produced by infections in patients in need thereof, characterized in that the treatment comprises the administration of a composition comprising IgM and the purity of the IgM is at least 90%.

2. The method according to claim 1 , characterized in that the infection is produced by Escherichia coli, Pseudomonas aeruginosa, Staphyloccus aureus, Klebsiella pneumoniae, Streptococcus pneumoniae, Clostridium difficile, Clostridium botulinum , or combinations thereof.

3. The method according to claim 1 , characterized in that treatment of immune complications is performed through immunomodulation.

4. The method according to claim 3 , characterized in that immunomodulation is performed through the inhibition of NF-κB induction, through the inhibition of the proliferation of peripheral blood mononuclear cells, or a combination thereof.

5. The method according to claim 1 , characterized in that the IgM purity is at least 95%.

6. The method according to claim 1 , characterized in that the dose to be administered of the composition is from 75 mg IgM/kg patient to 1 g IgM/kg patient.

7. The method according to claim 6 , characterized in that the composition is administered at least once a week.

8. The method according to claim 1 , characterized in that the IgM is recombinant, cell culture-derived, transgenic or chemically synthesized.

9. The method according to claim 1 , wherein the IgM is plasma-derived IgM isolated from a suitable fraction of plasma.

10. The method according to claim 1 , characterized in that the composition comprising IgM is administered alone.

11. The method according to claim 1 , characterized in that the composition comprising IgM is administered together with one or more other compositions or molecules selected from anti-inflammatory molecules, small molecule antibiotics, molecules that are antimicrobial in nature, natural or synthetic peptide antimicrobials, proteins with antimicrobial properties, other immunomodulators or combinations thereof.

12. The method according to claim 11 , characterized in that said other compositions or molecules are vancomycin, meropenem, lactoferrin or combinations thereof.

13. A method for the immunomodulation of an infection in a patient in need thereof, characterized in that the method comprises the administration of a composition comprising IgM and the purity of the IgM is at least 90%.

14. The method according to claim 13 , characterized in that immunomodulation is used for the treatment of infections or infection-related symptoms or conditions.

15. The method according to claim 13 , characterized in that the infection is produced by Escherichia coli, Pseudomonas aeruginosa, Staphyloccus aureus, Klebsiella pneumoniae, Streptococcus pneumoniae, Clostridium difficile, Clostridium botulinum , or combinations thereof.

16. The method according to claim 13 , characterized in that immunomodulation is performed through the inhibition of NF-κB induction, through the inhibition of the proliferation of peripheral blood mononuclear cells, or a combination thereof.

17. The method according to claim 13 , characterized in that the IgM purity is at least 95%.

18. The method according to claim 13 , characterized in that the dose to be administered of the composition is from 75 mg IgM/kg patient to 1 g IgM/kg patient.

19. The method according to claim 18 , characterized in that the composition is administered at least once a week.

20. The method according to claim 13 , characterized in that IgM is recombinant, cell culture-derived, transgenic or chemically synthesized.

21. The method according to claim 13 , wherein the IgM is plasma-derived IgM isolated from a suitable fraction of plasma.

22. The method according to claim 13 , characterized in that the composition comprising IgM is administered alone.

23. The method according to claim 13 , characterized in that the composition comprising IgM is administered together with one or more other compositions or molecules selected from anti-inflammatory molecules, small molecule antibiotics, molecules that are antimicrobial in nature, natural or synthetic peptide antimicrobials, proteins with antimicrobial properties, other immunomodulators or combinations thereof.

24. The method according to claim 23 , characterized in that said other compositions or molecules are vancomycin, meropenem, lactoferrin or combinations thereof.

25. The method according to claim 1 , wherein the immune complications are associated with sepsis.

26. The method according to claim 25 , characterized in that sepsis is produced by Escherichia coli, Pseudomonas aeruginosa, Staphyloccus aureus, Klebsiella pneumoniae, Streptococcus pneumoniae, Clostridium difficile, Clostridium botulinum , or combinations thereof.

27. The method according to claim 25 , characterized in that treatment of sepsis is performed through immunomodulation.

28. The method according to claim 27 , characterized in that immunomodulation is performed through the inhibition of NF-κB induction, through the inhibition of the proliferation of peripheral blood mononuclear cells, or a combination thereof.

29. The method according to claim 25 , characterized in that the IgM purity is at least 95%.

30. The method according to claim 29 , characterized in that the IgM purity is 95%.

31. The method according to claim 25 , characterized in that the dose to be administered of the composition is from 75 mg IgM/kg patient to 1 g IgM/kg patient.

32. The method according to claim 31 , characterized in that the composition is administered at least once a week.

33. The method according to claim 25 , characterized in that IgM is recombinant, cell culture-derived, transgenic or chemically synthesized.

34. The method according to claim 25 , wherein the IgM is plasma-derived IgM isolated from a suitable fraction of plasma.

35. The method according to claim 25 , characterized in that the composition comprising IgM is administered alone.

36. The method according to claim 25 , characterized in that the composition comprising IgM is administered together with one or more other compositions or molecules selected from anti-inflammatory molecules, small molecule antibiotics, molecules that are antimicrobial in nature, natural or synthetic peptide antimicrobials, proteins with antimicrobial properties, other immunomodulators or combinations thereof.

37. The method according to claim 36 , characterized in that said other compositions or molecules are vancomycin, meropenem, lactoferrin or combinations thereof.

38. The method of claim 1 , wherein the composition is essentially free of IgG and IgA.

39. The method of claim 1 , wherein the composition lacks IgG and IgA.

Assignees

• Grifols Worldwide Operations Ltd

Inventors

• Barnett Thomas
• Ross David A

Classifications

• A61P43/00

  Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 · CPC title

• A61P31/04

  Antibacterial agents · CPC title

• A61P37/06

  Immunosuppressants, e.g. drugs for graft rejection · CPC title

• A61P37/02

  Immunomodulators · CPC title

• A61K39/40 Primary

  bacterial · CPC title