Method for treating infectious diseases using a composition comprising plasma-derived immunoglobulin M (IgM)

Patent metadata

Field	Value
Publication number	US-11208471-B2
Application number	US-202016745563-A
Country	US
Kind code	B2
Filing date	Jan 17, 2020
Priority date	Aug 6, 2015
Publication date	Dec 28, 2021
Grant date	Dec 28, 2021

Abstract

Compositions and methods of the present invention prevent, inhibit or reduce the toxic effects of proteins and toxins secreted from microbes. A method for neutralizing microbial protein products in a subject comprises administering a composition to the subject, said composition comprising plasma-derived IgM and optionally one or more excipients in a pharmaceutical carrier, wherein the composition is administered in an amount effective to neutralize the microbial protein products.

First claim

What is claimed is:

1. A method for treating a microbial infection, the method comprising administering to a subject in need thereof a therapeutically effective amount of a composition consisting essentially of a plasma-derived IgM, and, optionally one or more excipients in a diluent or vehicle, wherein:
the plasma-derived IgM is obtained from a waste stream of a standard blood fractionation process; and
the microbial infection is an infection with a microorganism selected from the group consisting of Aspergillus flavus, Candida albicans, Streptococcus pneumonia, Clostridium difficile, Clostridium tetani, Listeria monocytogenes, Lactobacillus rhamnosus, Escherichia coli, Pseudomonas aeruginosa, Klebsiella pneumoniae, Helicobacter pylori, Legionella pneumophila , and Porphyromonas gingivalis , and
wherein the microbial infection is not an infection with Staphylococcus aureus.

2. The method of claim 1 , wherein the microbial infection is not an infection with Clostridium botulinum.

3. The method of claim 1 , wherein the plasma-derived IgM is administered to a subject in a dose of 75 mg to 1 g per kilogram of the subject.

4. The method of claim 1 , wherein the plasma-derived IgM is administered to a subject in a dose of 75 mg to 600 mg per kilogram of the subject.

5. The method of claim 1 , wherein the plasma-derived IgM is administered to the subject in a dose of 75 mg to 300 mg per kilogram of the subject.

6. The method of claim 1 , wherein the plasma-derived IgM is administered daily, every other day, 3 times per week, or once per week.

7. A method for treating a microbial infection, the method comprising administering to a subject in need thereof a therapeutically effective amount of a composition consisting essentially of:
a therapeutic molecule consisting essentially of plasma-derived IgM, and,
optionally one or more excipients in a diluent or vehicle, wherein the microbial infection is an infection with a microorganism selected from the group consisting of Aspergillus flavus, Candida albicans, Streptococcus pneumoniae, Clostridium difficile, Clostridium botulinum, Clostridium tetani, Listeria monocytogenes , and Lactobacillus rhamnosus ; and
wherein the microbial infection is not an infection with Staphylococcus aureus.

8. The method of claim 7 , wherein:
the microbial infection is a fungal infection; and
the fungal infection is an infection with a fungus selected from the group consisting of Aspergillus flavus and Candida albicans.

9. The method of claim 7 , wherein:
the microbial infection is a bacterial infection; and
the bacterial infection is an infection with bacteria selected from the group consisting of Streptococcus pneumoniae, Clostridium difficile, Clostridium botulinum, Clostridium tetani, Listeria monocytogenes , and Lactobacillus rhamnosus.

10. The method of claim 7 , wherein:
the plasma-derived IgM is obtained from a waste stream of a standard blood fractionation process;
the microbial infection is a bacterial infection;
the bacterial infection is an infection with bacteria selected from the group consisting of Streptococcus pneumoniae, Clostridium difficile, Clostridium tetani, Listeria monocytogenes , and Lactobacillus rhamnosus ; and
the bacterial infection is not an infection with Staphylococcus aureus.

11. The method of claim 7 , wherein:
the plasma-derived IgM is obtained from a waste stream of a standard blood fractionation process;
the microbial infection is a bacterial infection;
the bacterial infection is an infection with bacteria selected from the group consisting of Streptococcus pneumoniae, Clostridium difficile, Clostridium botulinum, Clostridium tetani, Listeria monocytogenes , and Lactobacillus rhamnosus ; and
the plasma-derived IgM is administered at a dosage sufficient to neutralize cytotoxic exotoxins secreted by the bacteria in the subject.

12. The method of claim 8 , wherein the fungus is Aspergillus flavus.

13. The method of claim 8 , wherein the fungus is Candida albicans.

Assignees

• Grifols Worldwide Operations Ltd

Inventors

• Barnett Thomas
• Ross David A

Classifications

• A61K38/1741

  alpha-Glycoproteins · CPC title

• C07K16/1232

  Escherichia (G) · CPC title

• A61K38/14

  Peptides containing saccharide radicals; Derivatives thereof {, e.g. bleomycin, phleomycin, muramylpeptides or vancomycin} · CPC title

• C07K2317/52

  Constant or Fc region; Isotype · CPC title

• C07K16/1214

  Pseudomonadaceae (F) · CPC title