Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Bacterium or component thereof or substance produced by said...
Patent
1996-08-07
1998-03-10
Witz, Jean C.
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Bacterium or component thereof or substance produced by said...
514 2, 514 21, A61K 3828, A61K 3910
Patent
active
057258600
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
This invention relates to the field of prevention of diabetes in humans and other mammals by vaccination, more particularly to prevention of type I or juvenile diabetes but also to prevention of at least some cases of adult diabetes and also to prevention of certain other autoimmune diseases.
BACKGROUND
Diabetes mellitus of the juvenile onset type is a relatively common and incurable disease believed to be caused by an autoimmune reaction against the beta cells of the islets of Langerhans in the pancreas. The beta cells, which are the only source of insulin, become the selected subjects of attack by components of the immune system as a result of sensitisation and are usually totally destroyed.
Diabetes is a nasty disease in that it is substantially incurable and typically requires daily injections of insulin for life in order to control the symptoms by replacing the secretions of the destroyed cells. Injections may not be available in poorer countries which often lack the means for such a treatment. Diabetes has an incidence (in its juvenile form, also known as Type I) of about 200 cases per year in New Zealand (population 3.2 million). Apart from the suffering as a result of the disease and as a result of the necessary dietary restrictions and the treatment itself (which is not without hazards) it is estimated that lifetime treatment of a juvenile diabetes case costs around NZ $1 million. A second form of diabetes--maturity onset diabetes--has an incidence of over 1 in 100 and some (perhaps 20%) of these cases are believed to be a late-onset type I diabetes of autoimmune origin.
Baeder et al (U.S. Pat. No. 5,321,009) advocates medication with rapamycin to modify the autoimmune response in patients with diabetes--this at least partially can reduce the dose of insulin required. Nevertheless it is a pragmatic and fundamental principle of medicine that immunisation is almost always preferable to medication. A method of protecting an individual from the appearance of diabetes could therefore be worth several hundred million dollars annually to a country having the population size of New Zealand.
OBJECT
It is an object of the present invention to provide an improved procedure for the prevention or alleviation of diabetes mellitus or one which will at least provide the public with a useful choice.
STATEMENT OF THE INVENTION
In one aspect the invention provides a composition for use in treatment of mammals, the composition comprising a mixture of an effective amount of an adjuvant and an effective amount of an antigen in a pharmaceutically acceptable carrier, wherein the adjuvant includes killed cells of Haemophilus pertussis or components thereof.
In a broad aspect the invention provides a composition for use in treatment of mammals affected by, or liable to be affected by, an auto-immune disease, the composition comprising a mixture of an effective amount of an adjuvant and an effective amount of an antigen in a pharmaceutically acceptable carrier, wherein the adjuvant includes killed cells of Haemophilus pertussis or components thereof.
In a related aspect the invention provides a composition for use in treatment of mammals affected by, or liable to be affected by the disease known as diabetes, the composition comprising a mixture of an effective amount of an adjuvant and a portion of an insulin molecule in an effective amount, in a pharmaceutically acceptable carrier, wherein the adjuvant includes killed cells of Haemophilus pertussis or components thereof.
Preferably the adjuvant also contains tetanus toxoid and diphtheria toxoid.
Preferably the adjuvant also contains antigenic material from Haemophilus influenzae type B.
Preferably the portion of the insulin molecule used comprises at least a portion of the A chain peptide of that molecule.
Preferably the entire A chain is used.
Optionally the portion of the insulin molecule used comprises at least a portion of the "A" chain, and a portion of the "B" chain.
In another broad aspect, the invention provides a method for the adm
REFERENCES:
Huang et al., Pediatric Research 18(2): 221-226 (1984).
Hollins et al., Clin. Exp, Immunol. 38: 127-134 (1979).
Hollins et al., Clin. Exp. Immunol. 31: 464-471 (1978).
Kolb et al., Diabetes Research 6: 21-27 (1987).
Auckland UniServices Limited
Witz Jean C.
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