Drug – bio-affecting and body treating compositions – Lymphokine
Patent
1985-03-28
1987-04-28
Schain, Howard E.
Drug, bio-affecting and body treating compositions
Lymphokine
424 86, 424 88, 424 89, 514 6, 530387, 530399, 530403, 530806, 530856, A61K 3939
Patent
active
046613463
DESCRIPTION:
BRIEF SUMMARY
This invention relates to immunological compositions and the use thereof.
Antigenic materials are widely used in both a human and a veterinary context in prophylactic therapy against, or in the treatment of, infectious diseases and of other types of undesirable biological reactions such as those induced through the bite of a snake or other venomous creature. The antigenic material may be used either in an active immunisation schedule through direct administration of the material to the intended recipient or in a passive inmunisation schedule where it is used to produce antibodies which are then administered to the recipient. It is often the case, however, that an antigenic material may not be as immunogenic as could be desired, thereby necessitating the use of a plurality of injections. As an alternative, or in addition to the use of repeated injections, an adjuvant may be used in order to increase the immune response provoked by the antigenic material. However, the effective adjuvants at present available, for example Freund's incomplete and complete adjuvants, have disadvantages, particularly for human use. For some time, therefore, attempts have been made to discover new forms of adjuvant which would simplify immunisation procedures and reduce the amounts of antigenic material required or amplify the response to a given quantity of antigenic material.
The quite unexpected finding has now been made that the members of a small group of oxides comprising osmium tetroxide, potassium permanganate and ruthenium tetroxide are able to enhance the immune response provoked by antigenic materials of certain types, both in terms of the level of the initial response and the duration of the response.
Osmium tetroxide, in particular, has previously been widely used as a fixing agent in electron microscopic studies of biological samples and in this context its reaction with the proteins lysozyme and ovalbumin has been studied. It has also received some use in the treatment of rheumatoid synovitis through direct administration into the knee. However, these uses are quite unrelated to the context of the present invention which involves the first use in therapy of an immunogenic composition (i.e. a composition producing an immunological reaction) comprising a peptide or protein material and osmium tetroxide, potassium permanganate or ruthenium tetroxide, specifically in the production of immunological reactions.
According to the present invention a composition for use in the production of an immunological reaction to a peptide or protein material comprises said peptide or protein material together with an oxide selected from the group consisting of osmium tetroxide, potassium permanganate and ruthenium tetroxide.
Without imposing any limitation upon the present invention with respect to the nature of such binding, which is however believed to be of a covalent nature, it may be stated that the peptide or protein material and the oxide are in general believed to be associated in some form of binding. Indeed, it is preferred, in order to produce a suitable form of composition lacking toxic side effects, to employ in the preparation of the composition a specific step, usually involving dialysis, which substantially removes low molecular weight products which are derived from the oxide, particularly the metal and the oxide itself, which are not either peptide- or protein-bound or lipid bound (when the composition is a microvesicle preparation as described hereinafter). The oxide of particular interest for use in the present invention is osmium tetroxide and for the sake of simplicity only therefore, the invention is further described by reference to that oxide, although it will be appreciated that potassium permanganate and ruthenium oxide may in general be used in an exactly analogous manner.
A wide variety of peptide and protein antigenic materials (the term "peptide or protein material" as used herein includes materials which consist of a compound comprising a peptide or protein portion as well as a portion having a differe
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New Roger R. C.
Theakston Robert D. G.
National Research Development Corporation
Schain Howard E.
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