Alkaloid glycoside for use as a medicament

Drug – bio-affecting and body treating compositions – Nonspecific immunoeffector – per se ; or nonspecific... – Lipid or oil

Reexamination Certificate

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C424S279100, C424S185100, C514S024000, C514S025000, C536S004100

Reexamination Certificate

active

06673357

ABSTRACT:

The present invention relates to a compound. More especially, the present invention relates to an adjuvant for use in a vaccine. In a more particular embodiment, the present invention relates to a glycoside adjuvant.
In the majority of vaccines used to date antibodies are raised against proteins that are present on the surfaces of disease-causing (pathogenic) organisms (e.g. viruses, bacteria). Vaccine formulations typically contain inactivated or killed pathogens. In many situations it is desirable to elicit an antibody response against a particular set of proteins, peptides or carbohydrates that are present in the pathogen. This leads to a well-defined response which can be targeted against proteins that are highly conserved between different strains of the pathogen, thereby achieving a broader-based immunity.
Furthermore, the ability to stimulate both class I- and class II-restricted immune responses is deemed to be important because it leads to a more comprehensive level of immunity than is currently achieved with existing vaccines.
Briefly, class II-restricted responses involve the production of antibodies that are specific to the proteins or peptides used in the vaccine—this is often referred to as the humoral immune response.
Class I-restricted immune responses are cell-mediated responses that are responsible for detecting and dealing with viral infections. In contrast to the class II-restricted responses, class I responses involve the activation of CD8+ cytotoxic T lymphocytes (CTLs). These CTLs are activated by oligomeric peptides that are derived from non-self proteins. These peptides are presented at the surface of cells in conjunction with the products of the major histocompatibility complex I (MHC-1). Activated CTLs are able to recognise and destroy virus-infected cells that have non-self oligopeptides on their surfaces.
The use of adjuvants in vaccine formulations leads to enhanced immune responses, particularly against soluble proteins and peptides which are only weakly immunogenic.
Several adjuvants have been described in the literature (e.g. complete or incomplete Freund's adjuvant) but most are only of experimental interest because of their severe inflammatory side-effects. So far, saponin-based adjuvants are believed by some to be amongst the most promising because of their activity and their relatively low toxicity and inflammatory side-effects.
By way of example, EP-A-0231039 discloses the use of a saponin glycoside as an adjuvant for vaccines. These particular adjuvants, which are in the form of nanoparticles, are characterised by their unique architectures and are often referred to as immunostimulatory complexes (ISCOMS). These are produced by mixing a saponin glycoside and cholesterol in aqueous solutions, often in the presence of a lipid and detergent, followed by one or more purification steps. The saponin is present in at least its critical micellar concentration (CMC). The ability of ISCOMS to elicit high antibody titres against a wide range of antigenic proteins and peptides has been demonstrated as has their ability to induce CTL activity (i.e. the ISCOM nanoparticles can stimulate both class I- and class II-restricted immune responses).
However, there is still a continuing need to develop adjuvants for vaccines, in particular adjuvants that can stimulate class I-restricted and/or class II-restricted immune responses to naturally occurring or synthetic proteins and oligopeptides.
According to a first aspect of the present invention there is provided an alkaloid glycoside for use in medicine.
According to a second aspect of the present invention there is provided an alkaloid glycoside for the stimulation of a class I-restricted immune response and/or a class II-restricted immune response.
According to a third aspect of the present invention there is provided an alkaloid glycoside for use as a vaccine adjuvant.
According to a fourth aspect of the present invention there is provided the use of an alkaloid glycoside in the manufacture of a medicament for use as a vaccine.
According to a fifth aspect of the present invention there is provided the use of an alkaloid glycoside as an adjuvant in the manufacture of a medicament for use as a vaccine.
According to a sixth aspect of the present invention there is provided the use of an alkaloid glycoside in the manufacture of a medicament to stimulate a class I-restricted immune response and/or a class II-restricted immune response.
According to a seventh aspect of the present invention there is provided a process of preparing a composition comprising admixing an agent capable of inducing an immune response with an alkaloid glycoside, wherein the agent is in an amount to cause an induction of an immune response and wherein the alkaloid glycoside is in an amount for use as an adjuvant.
According to an eighth aspect of the present invention there is provided a process of preparing a composition comprising admixing an agent capable of inducing an immune response with an alkaloid glycoside, wherein the agent is in an amount to cause an induction of an immune response and wherein the alkaloid glycoside is in an amount to cause stimulation of a class I-restricted immune response and/or a class II-restricted immune response.
According to a ninth aspect of the present invention there is provided a method of treatment, the method comprising administering to a subject a composition wherein the composition comprises an agent capable of inducing an immune response within the subject and wherein the composition also comprises an alkaloid glycoside, wherein the agent is in an amount to cause an induction of an immune response and wherein the alkaloid glycoside is in an amount for use as an adjuvant.
According to a tenth aspect of the present invention there is provided a method of treatment, the method comprising administering to a subject an alkaloid glycoside, wherein the alkaloid glycoside is in an amount to cause stimulation of a class I-restricted immune response and/or a class II-restricted immune response.
According to an eleventh aspect of the present invention there is provided a method of treatment, the method comprising administering to a subject in need of treatment a composition wherein the composition comprises an agent capable of inducing an immune response within the subject and wherein the composition also comprises an alkaloid glycoside, wherein the agent is in an amount to cause an induction an immune response and wherein the alkaloid glycoside is in an amount to cause stimulation of a class I-restricted immune response and/or a class II-restricted immune response.
According to a twelfth aspect of the present invention there is provided the combination of an alkaloid glycoside and an agent capable of inducing an immune response.
According to a thirteenth aspect of the present invention there is provided the combination of two or more compositions for sequential or consecutive administration to a subject, wherein at least one composition comprises an alkaloid glycoside and at least one other composition comprises an agent capable of inducing an immune response.
Thus, the present invention is based on the surprising finding that it is possible to use an alkaloid glycoside for a medical usuage, in particular for the stimulation of a class I-restricted immune response and/or a class II-restricted immune response. This finding is highly surprising as R. Bomford, M. Stapleton, J. E. Beesley, E. A Jessup, K. R. Price, G. R. Fenwick (in “Adjuvanticity and ISCOM formation by structurally divests saponins”;
Vaccine
, vol.10, (1992), 572-577.) state that glycoalkaloids (i.e. alkaloid glycosides) lack adjuvant activity.
The term “subject” includes any one or more different types of animal, including humans. Preferably, the term means a human.
The term “glycoside” as used herein means a derivative of a sugar (which may be a simple sugar or a complex sugar) in which the hydroxyl group attached to carbon 1 of the sugar is substituted by an alcoholic, or other, aglycone group.
In a preferred embodiment, the

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