Patent ID: 8404250

Claim:
A method of treating autoimmune diseases and allergy, the method comprising administering to a patient in need of such treatment, an amount effective to induce modulation of an immune response against a self antigen or an allergen of at least one of a bacterial preparation consisting of killed non-denatured Mycobacterium bovis BCG cells and less than 1.5% of residual water; a pharmaceutical composition, comprising (1) a bacterial preparation consisting of killed non-denatured Mycobacterium bovis BCG cells and less than 1.5% of residual water or at least one fraction thereof with less than 0.5% residual water, and (2) one or more of a pharmaceutically acceptable carrier, an additive, an immunostimulant, an adjuvant and an immunomodulator distinct from the bacterial preparation, wherein the pharmaceutical composition does not comprise any living bacteria and comprises less than 0.5% residual water; and a bacterial preparation comprising killed non-denatured Mycobacterium bovis BCG cells and less than 0.5% residual water, which is prepared by a process comprising harvesting a culture of live bacteria cells, freezing the bacteria cells in water or in an aqueous solution of salt, killing the frozen bacteria cells by drying them in a lyophilise, for a time sufficient to remove at least 99.5% of the water, and collecting the freeze-dried killed bacteria cells, wherein the bacterial preparation does not comprise any living bacteria.