Nebulization of monoclonal antibodies for treating pulmonary diseases

• US 20050271660A1
• Filed: 05/11/2005
• Published: 12/08/2005
• Est. Priority Date: 09/06/2002
• Status: Abandoned Application

• Current Assignee: Alexion Pharmaceuticals Incorporated (Astrazeneca PLC)
• Original Assignee: Alexion Pharmaceuticals Incorporated (Astrazeneca PLC)
• Inventors: Wang, Yi
• Application Number:
  US11/127,438
• Publication Number:
  US 20050271660A1
• Time in Patent Office: Days
• US Class Current: 424/144.100
• CPC Class Codes: A61K 2039/505 comprising antibodies
• CPC Class Codes: A61K 2039/54 characterised by the route of administration
• CPC Class Codes: A61K 2039/543 intranasal
• CPC Class Codes: A61K 2039/544 to the airways
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 11/06 Antiasthmatics
• CPC Class Codes: A61P 11/08 Bronchodilators
• 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 35/00 Antineoplastic agents
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 9/14 Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
• CPC Class Codes: C07K 16/18 against material from animals or humans
• CPC Class Codes: C07K 2317/55 Fab or Fab'
• CPC Class Codes: C07K 2317/56 variable (Fv) region, i.e. VH and/or VL
• CPC Class Codes: C07K 2317/565 Complementarity determining region [CDR]

Abstract

The present application relates to methods and compositions employing an antibody that inhibits activation of the complement system and can be used to prevent or treat a pulmonary disease or condition.

Claims

1. A method for preventing or treating a pulmonary condition in a subject comprising administering to the subject a therapeutically effective amount of an antibody that inhibits activation of the complement cascade and an additional active agent.

2. The method of claim 1, wherein the pulmonary condition is selected from the group consisting of:

asthma, bronchitis, a chronic obstructive pulmonary disease (COPD) interstitial lung diseases, lung malignancies, α

-1 anti-trypsin deficiency, emphysema, bronchiectasis, bronchiolitis obliterans, sarcoidosis, pulmonary fibrosis, and collagen vascular disorders.

3. The method of claim 1, wherein the subject is a human.

4. The method of claim 1, wherein the antibody is specific to C5.

5. The method of claim 1, wherein the antibody is specific to C5 convertase.

6. The method of claim 1, wherein the antibody is specific to C5a or C5b-9.

7. The method of claim 1, wherein the antibody is eculizumab or pexelizumab.

8. The method of claim 1, wherein the antibody is selected from the group consisting of:

a full length immunoglobulin, a single chain antibody, a domain antibody, a Fab fragment, and an antibody having a Fab fragment and a mutated Fc portion.

9. The method of claim 7, wherein the mutated Fc portion does not activate complement.

10. The method of claim 1, wherein the antibody is administered prior to manifestation of the pulmonary condition, during manifestation of the pulmonary condition, or after manifestation of the pulmonary condition.

11. The method of claim 1, wherein the additional active agent is a corticosteroid.

12. The method of claim 1, wherein the corticosteroid is dexamethasone.

13. The method of claim 1, wherein the antibody and the additional active agent may be administered to the subject by the same delivery method or route.

14. The method of claim 1, wherein the antibody and the additional active agent may be administered to the subject by different delivery methods or routes.

15. An aerosol composition comprising an antibody that inhibits activation of the complement cascade, wherein the composition is suitable for preventing or treating a pulmonary condition in a subject.

16. The aerosol composition of claim 15, wherein the antibody is formulated in a composition suitable for aerosolization.

17. The aerosol composition of claim 15 further comprising an additional active agent.

18. A biopharmaceutical package comprising:

a) an antibody that inhibits activation of the complement cascade; and

b) a nebulizer, wherein the package is suitable for preventing or treating a pulmonary condition in a subject.

19. The biopharmaceutical package of claim 18, wherein the nebulizer is selected from the group consisting of a jet air nebulizer, an ultrasonic nebulizer, a vibrating mesh nebulizer and a shockwave nebulizer.

20. The biopharmaceutical package of claim 19 further comprising instructions for use.

21. The biopharmaceutical package of claim 19 further comprising an additional active agent.

22. A pulmonary drug delivery kit comprising:

a) an inhaler; and

b) an antibody formulated for inhalation delivery.

23. The kit of claim 22, wherein said inhaler is a metered dose inhaler.

24. The kit of claim 23, whereon the metered dose inhaler is a pressurized metered dose inhaler.

25. The kit of any one of claims 22 or 23, wherein said inhaler further comprises a holding chamber.

26. The kit of claim 22, wherein said inhaler is a nebulizer.

27. The kit of claim 26, wherein said nebulizer is an ultrasonic nebulizer.

28. The kit of claim 26, wherein said nebulizer is a jet air nebulizer.

29. The kit of claim 22, wherein said inhaler is a dry powder inhaler.

30. A pulmonary drug delivery kit comprising a) an anti C5 antibody composition comprising 1 mg/ml to 200 mg/ml;

and b) a label indicating administration by nebulization.