Drug – bio-affecting and body treating compositions – Immunoglobulin – antiserum – antibody – or antibody fragment,...
Reexamination Certificate
1999-05-07
2001-03-13
Witz, Jean C. (Department: 1651)
Drug, bio-affecting and body treating compositions
Immunoglobulin, antiserum, antibody, or antibody fragment,...
C424S171100
Reexamination Certificate
active
06200565
ABSTRACT:
FIELD OF THE INVENTION
This invention relates generally to the treatment of hearing loss, and particularly to the treatment of autoimmune sensorineural hearing loss by oral administration of a preparation of human immunoglobulins.
BACKGROUND OF THE INVENTION
Of the 25 million people who are hearing impaired, 85% suffer from sensorineural hearing loss (SNHL), a loss of hearing due to decreased hearing nerve function. There are various forms of inner ear disorders causing SNHL, including Meniere's disease, viral labyrinthitis, perilymph fistula, otosyphilis, and congenial or hereditary deafness. Sensorineural hearing loss is generally accompanied by ear fullness, tinnitus and disturbance of balance. A number of medical, dietary and surgical treatments are available for SNHL. See, e.g., Hicks and Wright III (1991)
Indiana Medicine
84(8): 450-544.
Autoimmune sensorineural hearing loss (ASNHL) has been considered by some as a separate entity of SNHL and by others as a cause for various forms of SNHL. ASNHL is characterized by progressive unilateral or bilateral deafness that, in its incipient stages, may fluctuate or become sudden and profound. The symptoms of ASNHL are quite similar to other forms of SNHL. ASNHL is believed to occur when the body's immune system attacks and progressively destroys the inner ear. The pathogenesis of ASNHL includes vasculitis of vessels supplying the inner ear, autoantibodies directed against inner ear antigenic epitopes or cross-reacting antibodies. See, e.g., Hicks and Wright III (1991) and U.S. Pat. No. 5,422,282 to Harris.
A traditional line of therapy for ASNHL has been oral or parenteral administration of various immunosuppressants including steroids, cytotoxic drugs (such as cyclophosphamide) or methotrexate. Steroid therapy is associated with various side effects, such as weight gain, facial puffiness and constitutional changes (Sismanis et al.,
Laryngoscope
104: 932-934, 1994). Cyclophosphamide has dramatic adverse effects as well, e.g., severe nausea and vomiting, thrombocytopenia, leukopenia and hemorrhagic cystitis (Sismanis et al., 1994). Methotrexate appears to be less toxic. However, large scale studies are required to confirm the efficacy of methotrexate for treating ASNHL (Sismanis et al., 1994). Plasmapheresis has been suggested as an alternative therapy for patients who are intolerant to steroids and/or cyclophosphamide, but has been considered as impractical (Luetje
Laryngoscope
99: 1137-1146, 1989).
Despite the different therapies currently available, there is a need for more effective methods of treating ASNHL with fewer accompanying side effects. The present invention provides effective methods for treating ASNHL by oral administration of a human immunoglobulin preparation.
SUMMARY OF THE INVENTION
The present invention provides a method of treating autoimmune sensorineural hearing loss in a patient in need thereof which comprises orally administering to the patient an effective amount of a human immunoglobulin preparation. Human immunoglobulin preparations suitable for use in the methods of the present invention can be made by any of the well-known methods used for preparing parenteral immunoglobulin preparations. Suitable IG preparations can also be obtained commercially. The human immunoglobulin preparation may include any of the known IG classes including IgA, IgG, IgM, IgE, and IgD. Preferably, the human immunoglobulin preparation comprises at least one of immunoglobulin G (IgG) or immunoglobulin A (IgA). Preparations of fragments of human immunoglobulins can also be used in accordance with the present invention. The immunoglobulin preparation is preferably provided in a pharmaceutically acceptable carrier and orally administered at about 0.2 to about 5 grams per day. Preferably, the immunoglobulin preparation is administered in two to five separate doses at about 0.15 grams to about 1 grams per dose.
In accordance with the present invention, oral administration of a human IG preparation may be accomplished alone or in combination with other treatment regimes.
REFERENCES:
patent: 5422282 (1995-06-01), Harris
patent: 5562902 (1996-10-01), Shoenfeld et al.
patent: 5674487 (1997-10-01), Smith et al.
patent: 5681571 (1997-10-01), Holmgren et al.
patent: WO 97 32598 (1997-09-01), None
patent: WO 98 05777 (1998-02-01), None
“New and controversial uses of intravenous gamma-globulin” (Pahwa, R. N.);Pediatric Infectious Disease Journal, 7(5) : S34-6, May 5, 1998, XP002112284 abstract.
Dwyer, J. M., (1996) “Immunoglobulins in autoimmunity: history and mechanisms of action”,Clinical and Experimental Rheumatology14 (Suppl.15): S3-S7.
Gardi, A., (1984) “Quality Control in the Production of an Immunoglobulin for Intravenous Use”,Blut, 48:337-344.
Hicks et al., (1991) “Treatment of sensorineural hearing loss”,Indiana Medicine, 84(8):540-544.
Kaveri et al., (1997) “Modulation of autoimmnue responses by intravenous immunoglobulin (IVIg)”,Multiple Sclerosis, 3:121-128.
Leibl et al., (1996) “Method for the isolation of biologically active monomeric immunglobulin A from a plasma fraction”,Journal of Chromatography B: Biomedical Application, 678:173-180.
Luetje, C., (1989) “Theoretical and Practical Implications for Plasmapheresis in Autoimmune Inner Ear Disease”,Laryngoscope, 99:1137-1146.
Plester et al., (1989) “Autoimmune Hearing Loss”,The American Journal of Otology, 10(3):188-192.
Sismanis et al., (1994) “Methotrexate Therapy for Autoimmune Hearing Loss: A Preliminary Report”,Laryngoscope, 104:932-934.
Tjellström et al., (1997) “Oral immunoglobulin treatment in Crohn's disease”,Acta Paediatr, 86:221-223.
Research Corporation Technologies Inc.
Scully Scott Murphy & Presser
Witz Jean C.
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