PROBIOTIC BIFIDOBACTERIUM STRAIN

• US 20120276143A1
• Filed: 05/10/2012
• Published: 11/01/2012
• Est. Priority Date: 11/11/2009
• Status: Active Grant

• Current Assignee: Barry Kiely, Eileen Frances Murphy, John Francis Cryan, Liam O'Mahony, Timothy Dinan
• Original Assignee: Alimentary Health Limited
• Inventors: Dinan, Timothy, O'MAHONY, Liam, Kiely, Barry, Cryan, John Francis, Murphy, Eileen Frances
• Granted Patent: US 10,144,978 B2
• Time in Patent Office: Days
• US Class Current: 424/234.1
• CPC Class Codes: A23C 9/1234 characterised by using a Lactobacillus sp. other than Lactobacillus Bulgaricus, including Bificlobacterium sp.
• CPC Class Codes: A23G 9/363 containing microorganisms, enzymes
• CPC Class Codes: A23L 33/135 Bacteria or derivatives thereof, e.g. probiotics
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A23V 2200/3204 Probiotics, living bacteria to be ingested for action in the digestive tract
• CPC Class Codes: A23V 2200/324 having an effect on the immune system
• CPC Class Codes: A23V 2400/533 Longum
• CPC Class Codes: A61K 35/745 Bifidobacteria
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/02 Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 1/12 Antidiarrhoeals
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 11/06 Antiasthmatics
• CPC Class Codes: A61P 13/12 of the kidneys
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 17/06 Antipsoriatics
• CPC Class Codes: A61P 17/10 : Anti-acne agents
• CPC Class Codes: A61P 19/02 : for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 19/10 : for osteoporosis
• CPC Class Codes: A61P 25/00 : Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/28 : for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
• 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 3/00 : Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• CPC Class Codes: A61P 3/04 : Anorexiants; Antiobesity agents
• CPC Class Codes: A61P 3/10 : for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 31/00 : Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 31/04 : Antibacterial agents
• CPC Class Codes: A61P 31/10 : Antimycotics
• CPC Class Codes: A61P 31/12 : Antivirals
• CPC Class Codes: A61P 31/18 : for HIV
• CPC Class Codes: A61P 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 35/04 : specific for metastasis
• CPC Class Codes: A61P 37/00 : Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 37/02 : Immunomodulators
• CPC Class Codes: A61P 37/06 : Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 37/08 : Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14
• CPC Class Codes: A61P 5/00 : Drugs for disorders of the endocrine system
• CPC Class Codes: A61P 7/02 : Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• CPC Class Codes: A61P 7/06 : Antianaemics
• CPC Class Codes: A61P 9/00 : Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/10 : for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: C12N 1/20 : Bacteria; Culture media therefor
• CPC Class Codes: C12N 1/205 : Bacterial isolates
• CPC Class Codes: C12R 2001/01 : Bacteria or Actinomycetales ; using bacteria or Actinomycetales
• CPC Class Codes: Y02A 50/30 : Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

Probiotic Bifidobacterium strain AH1714 is significantly immunomodulatory following oral consumption. The strain is useful as an immunomodulatory biotherapeutic agent.

Claims

1. An isolated strain of Bifidobacterium NCIMB 41676.

2. A Bifidobacterium strain as claimed in claim 1 in the form of viable cells.

3. A Bifidobacterium strain as claimed in claim 1 in the form of non-viable cells.

4. A Bifidobacterium strain as claimed in any of claims 1 to 3 wherein the Bifidobacterium is isolated from colonic biopsy tissue from a healthy human subject.

5. A Bifidobacterium strain as claimed in any of claims 1 to 4 wherein the strain is significantly immunomodulatory following oral consumption in humans.

6. A formulation which comprises a Bifidobacterium strain as claimed in any of claims 1 to 5.

7. A formulation as claimed in claim 6 which further comprises a probiotic material.

8. A formulation as claimed in claim 6 or 7 which further comprises a prebiotic material.

9. A formulation as claimed in any one of claims 6 to 8 further comprising an ingestable carrier.

10. A formulation as claimed in claim 9 wherein the ingestable carrier is a pharmaceutically acceptable carrier such as a capsule, tablet or powder.

11. A formulation as claimed in claim 9 wherein the ingestable carrier is a food product such as acidified milk, yoghurt, frozen yoghurt, milk powder, milk concentrate, cheese spreads, dressings or beverages.

12. A formulation as claimed in any one of claims 6 to 11 which further comprises a protein and/or peptide, in particular proteins and/or peptides that are rich in glutamine/glutamate, a lipid, a carbohydrate, a vitamin, mineral and/or trace element.

13. A formulation as claimed in any one of claims 6 to 12 wherein the Bifidobacterium strain is present in an amount of more than 10⁶ cfu per gram of the formulation.

14. A formulation as claimed in any one of claims 6 to 13 which further comprises an adjuvant.

15. A formulation as claimed in any one of claims 6 to 14 which further comprises a bacterial component.

16. A formulation as claimed in any one of claims 6 to 15 which further comprises a drug entity.

17. A formulation as claimed in any one of claims 6 to 16 which further comprises a biological compound.

18. A formulation as claimed in any one of claims 6 to 17 for immunisation and vaccination protocols.

19. A Bifidobacterium strain as claimed in any one of claims 1 to 5 or a formulation as claimed in any one of claims 6 to 18 for use in foodstuffs.

20. A Bifidobacterium strain as claimed in any one of claims 1 to 5 or a formulation as claimed in any one of claims 6 to 18 for use as a medicament.

21. A Bifidobacterium strain as claimed in any one of claims 1 to 5 or a formulation as claimed in any one of claims 6 to 18 for use in the prophylaxis and/or treatment of undesirable inflammatory activity.

22. A Bifidobacterium strain as claimed in any one of claims 1 to 5 or a formulation as claimed in any of claims 6 to 18 for use in the prophylaxis and/or treatment of undesirable gastrointestinal inflammatory activity such as inflammatory bowel disease eg. Crohns disease or ulcerative colitis, irritable bowel syndrome;

pouchitis;

or post infection colitis.

23. A Bifidobacterium strain as claimed in any one of claims 1 to 5 or a formulation as claimed in any one of claims 6 to 18 for use in the prophylaxis and/or treatment of gastrointestinal cancer(s).

24. A Bifidobacterium strain as claimed in any one of claims 1 to 5 or a formulation as claimed in any one of claims 6 to 18 for use in the prophylaxis and/or treatment of systemic disease such as rheumatoid arthritis.

25. A Bifidobacterium strain as claimed in any one of claims 1 to 5 or a formulation as claimed in any one of claims 6 to 18 for use in the prophylaxis and/or treatment of autoimmune disorders due to undesirable inflammatory activity.

26. A Bifidobacterium strain as claimed in any one of claims 1 to 5 or a formulation as claimed in any one of claims 6 to 18 for use in the prophylaxis and/or treatment of cancer due to undesirable inflammatory activity.

27. A Bifidobacterium strain as claimed in any one of claims 1 to 5 or a formulation as claimed in any one of claims 6 to 18 for use in the prophylaxis of cancer.

28. A Bifidobacterium strain as claimed in any one of claims 1 to 5 or a formulation as claimed in any one of claims 6 to 18 for use in the prophylaxis and/or treatment of diarrhoeal disease due to undesirable inflammatory activity, such as Clostridium difficile associated diarrhoea, Rotavirus associated diarrhoea or post infective diarrhoea or diarrhoeal disease due to an infectious agent, such as E. coli.

29. A Bifidobacterium strain as claimed in any one of claims 1 to 5 or a formulation as claimed in any one of claims 6 to 18 for use in the preparation of anti-inflammatory biotherapeutic agents for the prophylaxis and/or treatment of undesirable inflammatory activity.

30. Bifidobacterium strains as claimed in claim 29 for use in the preparation of a panel of biotherapeutic agents for modifying the levels of IL-10.

31. A Bifidobacterium strain as claimed in any one of claims 1 to 5 or a formulation as claimed in any one of claims 6 to 18 for use in the prevention and/or treatment of inflammatory disorders, immunodeficiency, inflammatory bowel disease, irritable bowel syndrome, cancer (particularly of the gastrointestinal and immune systems), diarrhoeal disease, antibiotic associated diarrhoea, paediatric diarrhoea, appendicitis, autoimmune disorders, multiple sclerosis, Alzheimer'"'"'s disease, rheumatoid arthritis, coeliac disease, diabetes mellitus, organ transplantation, bacterial infections, viral infections, fungal infections, periodontal disease, urogenital disease, sexually transmitted disease, HIV infection, HIV replication, HIV associated diarrhoea, surgical associated trauma, surgical-induced metastatic disease, sepsis, weight loss, anorexia, fever control, cachexia, wound healing, ulcers, gut barrier function, allergy, asthma, respiratory disorders, circulatory disorders, coronary heart disease, anaemia, disorders of the blood coagulation system, renal disease, disorders of the central nervous system, hepatic disease, ischaemia, nutritional disorders, osteoporosis, endocrine disorders, epidermal disorders, psoriasis, acne vulgaris, panic disorder, behavioral disorder and/or post traumatic stress disorders.

32. A Bifidobacterium strain as claimed in any one of claims 1 to 5 wherein the strain acts by antagonising and excluding proinflammatory micro-organisms from the gastrointestinal tract.

33. A Bifidobacterium strain as claimed in any one of claims 1 to 5 or a formulation as claimed in any one of claims 6 to 18 for use in the preparation of anti-inflammatory biotherapeutic agents for reducing the levels of pro inflammatory cytokines.

34. Use of a Bifidobacterium strain as claimed in any one of claims 1 to 5 as an anti-infective probiotic strain.

35. A Bifidobacterium strain as claimed in any one of claims 1 to 5 or a formulation as claimed in any one of claims 6 to 18 for use in the prophylaxis and/or treatment of bipolar illness, depression, mood disorders, and/or anxiety disorders.

36. Use of a Bifidobacterium strain as claimed in any one of claims 1 to 5 or a formulation as claimed in any one of claims 6 to 18 as a cognative enhancer for the prophylaxis and/or treatment of disorders of the central nervous system such as Alzheimer'"'"'s disease, schizophrenia and/or mild cognative disorder.

37. Use of a Bifidobacterium strain as claimed in any one of claims 1 to 5 or a formulation as claimed in any one of claims 6 to 18 for the prophylaxis and/or treatment of obesity related inflammation.

38. Use of a Bifidobacterium strain as claimed in any one of claims 1 to 5 or a formulation as claimed in any one of claims 6 to 18 for the prophylaxis and/or treatment of obesity related metabolic dysregulation.