IP Library Granted Patent US 9,913,903
Granted Patent B2
US 9,913,903 · App. 15/147,226 · Granted Mar 13, 2018

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

Inventors: Thomas Barnett (Chapel Hill, NC); David A. Ross (Cary, NC)
Assignee: Grifols Worldwide Operations Limited
A61K39/40A01K67/0275C07K16/00C07K2317/52C07K2317/70C07K2317/73C07K2317/76
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Quick Facts
Patent No.
US 9,913,903
App. No.
15/147,226
Granted
Mar 13, 2018
Kind
B2
Abstract

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

Claims (39)

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.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 19, 2018
From: BARNETT, THOMAS; ROSS, DAVID A
To: GRIFOLS WORLDWIDE OPERATIONS LIMITED
Reel/Frame 044666/0013 →
Continuity (2)
Provisional Application 62201917 · Aug 6, 2015
Related Publication 20170035882A1 · Feb 9, 2017