Mycobacterium vaccae for treatment of long term autoimmune condi

Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Bacterium or component thereof or substance produced by said...

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4241841, 42419711, 4352531, A61K 3904

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058855882

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BRIEF SUMMARY
This invention relates to the treatment of mental diseases associated with an autoimmune reaction initiated by an infection, and of the auto-immunologically mediated consequences (other than uveitis) of chronic infections.
British Specification No. 2156673 describes immunotherapeutic agents comprising killed cells of Mycobacterium vaccae. These agents are useful in the immunotherapy of mycobacterial disease, especially tuberculosis and leprosy. It is stated that use of this immunotherapeutic agent facilitates the removal of the persisting bacilli responsible for tuberculosis or leprosy which, as is well known, it is difficult to remove by chemotherapy alone. It is suggested in the specification that the immunotherapeutic agent is believed to act by presenting the "protective " common mycobacterial antigens to advantage and by containing immune suppressor determinants which are active in regulating disadvantageous immune mechanisms. As a consequence, "persister " bacilli are recognised by the immune system by their content of common mycobacterial antigens and effective immune mechanisms are directed against them, in the absence of the tissue necrotic form of immunity usually present in mycobacterial disease.
International Patent Specification PCT/GB5/0013 describes compositions for the alleviation of the symptoms of, and for the treatment or diagnosis of, arthritic diseases which comprise as active ingredient the whole organism of M. vaccae. It is stated that the preparations of M. vaccae are useful for the treatment of various autoimmune diseases and especially arthritic conditions including rheumatoid arthritis, ankylosing spondylitis or Reiter's syndrome.
International Patent Specification PCT/GB90/0131 discloses that compositions which comprise M. vaccae as active ingredient are useful in the treatment of other pathological conditions in which the patient shows an abnormally high proportion of agalactosyl IgG and also in the treatment of chronic inflammatory disorders caused or accompanied by an abnormally high release by macrophages of interleukin-6 and/or tumour necrosis factor. The specification refers in particular to the treatment of Crohn's disease, reactive arthritis, primary biliary cirrhosis, sarcoidosis, ulcerative colitis, psoriasis, systemic lupus erythematosus (especially when accompanied by Sjogren's syndrome), multiple sclerosis, Guillain-Barre syndrome, primary diabetes mellitus, and some aspects of graft rejection.
International Patent Specification PCT/GB90/01169 discloses antigenic and/or immunoregulatory material derived from M. Vaccae for use in delaying or preventing the onset of the AIDS syndrome.
Additionally, our unpublished International Patent Specification PCT/GB91/01970 discloses the use of M. vaccae in the treatment of uveitis, an immunologically mediated late consequence of leprosy, which causes blindness.
The present invention is based on the surprising, observation that M. vaccae is also effective against a number of other conditions which may involve infections such as bacterial or protozoan infections and in particular mycobacterial infections.
It has been suggested that mental diseases such as schizophrenia and manic depression are associated with an autoimmune reaction resulting from past or on-going cryptic infection. Evidence for this is provided by abnormal B and T lymphocyte function such as increased B cells, decreased T cells and altered suppressor cell levels which have been observed in schizophrenia (see for example P. Sirota, Israel J. Med. Sci, 1990, 26, 694-697; J. G. Knight, Meth and Find Exptl Clin; Pharmacol., 1984, 64, 395-403; H. H. Fudenberg et al, Biomedicine & Pharmacotherapy, 1984, 38, 285-290; F. Villemain et al, Annal. N.Y. Acad. Sci., 1987, 496, 669-675; and Ganguli et al, Annal. N.Y. Acad. Sci., 1987, 496, 676-685). Evidence is also provided by the observation that schizophrenia and rheumatoid arthritis almost never occur in the same patient (T. D. Spector, J. Silman, Brit. J. Rheumatology, 1987, 26, 307-310). We believe that schizophrenia and

REFERENCES:
patent: 4716038 (1987-12-01), Standord et al.
patent: 4724144 (1988-02-01), Rook et al.

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