Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Patent
1996-09-09
1998-09-01
Stanton, Brian R.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
4242781, 536 231, A61K 4500, A61K 4744, A61K 4800, C07H 2102
Patent
active
058011579
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a new composition comprising a recombinant plasmid, as well as to vaccines or curative medicaments comprising such a composition.
2. Description of the Related Art
Vaccination with live viruses or microorganisms has numerous well-known advantages compared to vaccination with non-live vaccines consisting of killed microorganisms or of isolated proteins or peptides.
Live vaccines consist of a live microorganism or a live virus. These latter are generally attenuated so as to decrease the pathogenic risks. However, this risk is never completely eliminated inasmuch as, in particular, a reversion of the microorganism or virus to a virulent form may occur.
Moreover, the mutations or deletions employed in order to bring about an attenuation of the virulence of the strains sometimes cause a decrease in the immune response, necessitating the injection of large doses of vaccines. Recently, new vaccines whose preparation has been made possible by the advances in genetic engineering have been developed. Among these new vaccines, there may be mentioned those consisting of a recombinant plasmid formed from a nucleotide sequence into which is inserted an exogenous nucleotide sequence originating from a microorganism or from a pathogenic virus. The purpose of the latter nucleotide sequence is to permit the expression of a compound comprising an amino acid sequence, the purpose of this compound itself being to trigger an immune reaction in a host body.
The first injection of such a plasmid, as well as its expression in a muscle, was performed and demonstrated in 1990 by Lin et al. (Circulation 82:2217-2221). The object of this experiment was to demonstrate that a recombinant plasmid injected into a living organism was capable of expressing the exogenous sequence in the tissues into which had been injected. It was demonstrated in this way that the administration of a recombinant plasmid to a living organism could be used in gene therapy. This therapeutic method is well known and consists, in particular, in administering to a host body genetically modified cells or, as demonstrated by Lin et al., recombinant plasmids capable of expressing compounds synthesized by living organisms, such as peptides, proteins or glycoproteins. The purpose of the in vivo synthesis of these compounds can be either to compensate for a deficiency of a genetic nature in the host body to which the genetically modified cells of the recombinant plasmids have been administered, or to have a curative action against a disease, such as a cancer, triggered in this same host body.
As an example, such a curative action may consist of a synthesis, by recombinant cells or recombinant plasmids, of cytokines such as interleukins, in particular interleukin-2. These cytokines enable an immune reaction directed towards the selective elimination of cancer cells to be triggered or enhanced.
Subsequently, it was shown that recombinant plasmids carrying a specific gene, coding for the glycoprotein of bovine herpesvirus I (BHV-1), were capable of inducing an immune response, consisting of the synthesis of antibody, in different animal species, namely mice and cattle (Cox et al., J. Virol. September 1993, 67, 9, 5664, 5667). However, this study also shows clearly a heterogeneity of the immune responses obtained. In other words, all other conditions being equal, the immune response is highly variable for each animal tested and each injection performed. It emerges from this that a few animals display a low level of antibodies, though sometimes sufficient to induce some degree of protection, whereas most of the other animals do not display an antibody level of this kind. In the latter case, no protection is induced.
SUMMARY OF THE INVENTION
The present invention thus consists of a composition comprising a recombinant plasmid capable of expressing, in a host body to which said recombinant plasmid has been administered, a larger amount of compounds of the peptide, protein or glycoprotein
REFERENCES:
Liu, F. et al (1996). Pharmaceutical Research 13, 1642-46.
Orkin, S. et al (1995). Report and Recommendations of the Panel to Assess e NIH Investment in Research in Gene Therapy.
Mulligan, R. (1993). Science 260, 926-930.
Ganne, V. (1994). Vaccine 12, 1190-6.
Haddada, H. et al. (1993). Biochemical and Biophysical Research Communications 195, 1174-83.
Roitt, I. (1994). Essential Immunology, Blackwell Scientific Publications, pp. 288-289.
by Lin, Hua et al., "Expression of Recombinant Genes in Myocardium In Vivo After Direct Injection of DNA", Circulation, vol. 82, No. 6, Dec. 1990, pp. 2217-2221.
by Cox, Graham J.M. et al., "Bovine Herpesvirus 1: Immune Responses in Mice and Cattle Injected with Plasmid DNA", Journal of Virology, vol. 67, No. 9, Sep. 1993, pp. 5664-5667.
Societe D'Exploitation de Produits Pour L'Industrie Chimique S.E
Stanton Brian R.
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