Pharmaceutical Composition for Protection from Allergies and Inflammatory Disorders

• US 20080305089A1
• Filed: 03/03/2008
• Published: 12/11/2008
• Est. Priority Date: 03/02/2007
• Status: Active Grant

• Current Assignee: Borstel Forschungszentrum, Ruhr-Universitã¤T Bochum
• Original Assignee: Protectimmun GmbH
• Inventors: Renz, Harald, Garn, Holger, Holst, Otto, Bufe, Albrecht, Bauer, Johann, Wegmann, Michael, Gatermann, Soren, Friedrich, Susanne, Blumer, Nicole, Hanuszkiewicz, Anna, von Mutius, Erika, Ege, Markus, Heine, Holger, Debarry, Jennifer
• Granted Patent: US 9,950,017 B2
• Time in Patent Office: Days
• US Class Current: 424/93.41
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 35/74 Bacteria therapeutic use of a bacterial protein A61K38/00
• CPC Class Codes: A61K 35/744 Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• 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 37/08 Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14

Abstract

The present invention relates to a pharmaceutical composition which includes naturally occurring, non-transgenic isolated bacteria from the group of Lactococcus and Acinetobacter or fragments thereof or mixtures thereof, to such a bacterium as a medicament for the prevention and/or treatment of allergic or chronic inflammatory disorders and to a process for producing this composition.

Claims

1. A pharmaceutical composition comprising naturally occurring, non-transgenic, isolated bacteria selected from the group consisting of Lactococcus and Acinetobacter or fragments thereof or a mixture thereof and, where appropriate, a pharmaceutically acceptable carrier for the prevention and/or treatment of allergic or chronic inflammatory disorders selected from IgE-dependent type I allergies or type IV allergies, and chronic inflammatory cutaneous disorders or autoimmune diseases.

2. The pharmaceutical composition as claimed in claim 1, which is in the form of an aerosol, aqueous solution, suspension, lyophilizate or powder.

3. The composition of claim 1, comprising a combination of Lactococcus and Acinetobacter in a mixing ratio of from 5:

95 to 95;

5.

4. The composition as claimed in claim 1, wherein the bacteria are selected from Lactococcus lactis and Acinetobacter lwoffii.

5. The composition as claimed in claim 1, wherein the bacteria are in the vital or killed state.

6. The composition as claimed in claim 1 for oral, nasal, conjunctival, inhalational, subcutaneous, intra-articular, intraperitoneal, rectal or vaginal administration.

7. The composition as claimed in claim 1, wherein said composition has effects for the prevention and/or treatment of hay fever, food allergies, asthma, neurodermatitis, atopic dermatitis, contact eczema, psoriasis, type 1 or 2 diabetes, multiple sclerosis, rheumatoid arthritis, thyroid disorders such as Hashimoto'"'"'s thyroiditis and Graves'"'"' disease.

8. The composition as claimed in claim 1, which is suitable for the prevention of allergic or chronic inflammatory disorders in babies or pregnant women who, owing to a positive family history, have a distinctly increased risk of developing such a disorder, and/or is suitable for the prevention or treatment of allergic or chronic inflammatory disorders in babies or pregnant women who show the first manifestations of such a disorder.

9. The composition as claimed in claims 1, further comprising at least one bacterium selected from the group consisting of Micrococcus spp., Planococcus spp., Staphylococcus spp., Streptococcus spp., Lactococcus spp., Aerococcus spp., Gemella spp., Enterococcus spp., Bacillus spp., Clostridium spp., Micromonospora spp., Lactobacillus spp., Listeria spp., Erysipelothrix spp., Acinetobacter spp., Leuconostoc spp., Corynebacterium spp., Clavibacter spp., Brevibacterium spp., Propionibacterium spp., Arthrobacter spp., Curtobacterium spp., Microbacterium spp., Aureobacterium spp., Cellulomonas spp., Agromyces spp., Eubacterium spp., Pseudomonas spp., Xantomonas spp., Frateuria spp., Zoogloea spp., Escherichia spp., Enterobacter spp., Pantoea spp., Erwinia spp., Citrobacter spp., Klebsiella spp., Proteus spp., Serratia spp., Actinomyces spp., Streptomyces spp., Nocardia spp., Mycobacterium spp., Absidia spp., Wallemia spp., Eurotium spp., Acremonium spp., Aspergillus spp., Penicillium spp., Cladosporium spp., Cephalosporium spp., Fusarium spp., Mucor spp., and Trichoderma spp., or in combination with trichothecenes, fumonisins, gliotoxin, ochratoxins, patulin, aflatoxins or fragments thereof or mixtures thereof.

10. A process for producing a pharmaceutical composition as claimed in claim 1, comprising the steps:

a isolating a natural, non-transgenic bacterium selected from the group consisting of Lactococcus and Acinetobacter,

b growing of the isolated bacterium in culture,

c where appropriate killing and/or lyophilizing the bacterium,

d where appropriate fragmentating the bacterium, and

e mixing the vital or, where appropriate, killed, lyophilized or fragmented bacterium with a pharmaceutically acceptable carrier.

11. The process as claimed in claim 10, where the pharmaceutically acceptable carrier is selected from the group consisting of water, alcohol, a buffer solution or salt solution, a hydroalcoholic mixture, pharmaceutically acceptable powder, ground silicate, starch, cellulose and cellulose derivatives.

12. A method for prevention and/or treatment of allergic or chronic inflammatory disorders selected from IgE-dependent type I allergies or type IV allergies, and chronic inflammatory cutaneous disorders or autoimmune diseases comprising administering to a subject in need thereof a pharmaceutical composition comprising naturally occurring, non-transgenic, isolated bacteria selected from the group consisting of Lactococcus and Acinetobacter or fragments thereof or a mixture thereof.

13. The method as claimed in claim 12, wherein said pharmaceutical composition is in the form of an aerosol, aqueous solution, suspension, lyophilizate or powder.

14. The method as claimed in claim 12, wherein said pharmaceutical composition comprises a combination of Lactococcus and Acinetobacter in a mixing ratio of from 5:

95 to 95;

5.

15. The method as claimed in claim 12, wherein said bacteria are selected from Lactococcus lactis and Acinetobacter lwoffii.

16. The method as claimed in claim 12, wherein said bacteria are in the vital or killed state.

17. The method as claimed in claim 12, wherein said pharmaceutical composition is for oral, nasal, conjunctival, inhalational, subcutaneous, intra-articular, intraperitoneal, rectal or vaginal administration.

18. The method as claimed in claim 12, wherein said pharmaceutical composition has effects for the prevention and/or treatment of hay fever, food allergies, asthma, neurodermatitis, atopic dermatitis, contact eczema, psoriasis, type 1 or 2 diabetes, multiple sclerosis, rheumatoid arthritis, thyroid disorders such as Hashimoto'"'"'s thyroiditis and Graves'"'"' disease.

19. The method as claimed in claim 12, wherein said pharmaceutical composition is suitable for the prevention of allergic or chronic inflammatory disorders in babies or pregnant women who, owing to a positive family history, have a distinctly increased risk of developing such a disorder, and/or is suitable for the prevention or treatment of allergic or chronic inflammatory disorders in babies or pregnant women who show the first manifestations of such a disorder.

20. The method as claimed in claim 12, wherein said pharmaceutical composition further comprises at least one bacterium selected from the group consisting of Micrococcus spp., Planococcus spp., Staphylococcus spp., Streptococcus spp., Lactococcus spp., Aerococcus spp., Gemella spp., Enterococcus spp., Bacillus spp., Clostridium spp., Micromonospora spp., Lactobacillus spp., Listeria spp., Erysipelothrix spp., Acinetobacter spp., Leuconostoc spp., Corynebacterium spp., Clavibacter spp., Brevibacterium spp., Propionibacterium spp., Arthrobacter spp., Curtobacterium spp., Microbacterium spp., Aureobacterium spp., Cellulomonas spp., Agromyces spp., Eubacterium spp., Pseudomonas spp., Xantomonas spp., Frateuria spp., Zoogloea spp., Escherichia spp., Enterobacter spp., Pantoea spp., Erwinia spp., Citrobacter spp., Klebsiella spp., Proteus spp., Serratia spp., Actinomyces spp., Streptomyces spp., Nocardia spp., Mycobacterium spp., Absidia spp., Wallemia spp., Eurotium spp., Acremonium spp., Aspergillus spp., Penicillium spp., Cladosporium spp., Cephalosporium spp., Fusarium spp., Mucor spp., and Trichoderma spp., or in combination with trichothecenes, fumonisins, gliotoxin, ochratoxins, patulin, aflatoxins or fragments thereof or mixtures thereof.