Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
2001-06-25
2004-03-23
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
C424S184100, C424S190100, C424S434000, C424S275100, C424S193100, C514S002600
Reexamination Certificate
active
06709672
ABSTRACT:
SUBJECT OF THE INVENTION
The present invention relates to a novel pharmaceutical or food composition intended for treating pathologies associated with graft rejection or an allergic or autoimmune reaction.
TECHNOLOGICAL BACKGROUND OF THE INVENTION
In the last twelve years, controlled studies have described desensitization based on the oral administration of allergens (1). This method is based on the fact that the oral administration of an antigen facilitates the acquisition of an immunological tolerance to it. The digestive route constitutes the mode of contact of the body with antigens, of food or microbial origin. However, allergic reactions are rare. Oral administration of sheep red blood cells (SRBC) to rats prevents the rats from later producing anti-SRBC antibodies after a subcutaneous injection, whereas, without the prior oral intake, the allergic response would have been present. This phenomenon constitutes what is referred to immunologically as oral tolerance.
This oral desensitization method has been validated in prospective and controlled studies, and makes it possible to reduce the risks of anaphylaxis, in particular for birch pollen and acari. It is already available on the vaccines market in a presentation in drinkable form (sold by the company Laboratoire des Stallergénes—Paris).
Moreover, it may be considered that the benefit, in terms of protecting infants against allergy to milk, which has been observed since the introduction of new, enzymatically predigested powdered milk formulations, would result from the induction of immunological tolerances by the presentation of antigens in the form of peptides.
Document WO-A-95/24920 describes the use of complexes consisting of the combination of a stress protein and a peptide as a prophylactic or therapeutic vaccine against intracellular pathogens.
That document does not in any way describe the possibility of using such complexes in vivo in the treatment of autoimmune or allergic diseases or graft rejections.
In the third paragraph of page 10, that document describes that said immunogenic and antigenic macromolecular structures can be associated with autoimmune or allergic diseases, and that, in this case, said antigen is administered in combination with said stress proteins in an amount which is sufficient to generate tolerance or to inhibit a pre-existing immune response against said antigen in an individual.
It is indicated that the amount of stress proteins required to inhibit this immune response is assumed to be substantially larger than the amounts required to obtain a stimulation.
However, it is difficult to predict or state the efficacy of the desensitization. Clinical observation makes it possible, after the event, to confirm or deny any improvement in the symptoms.
It is known, from international patent application WO 96/36880, to be able to detect and/or quantify ligands specific to a pathology associated with an allergic or autoimmune response or lung cancer, by means of a test of competition between ligands present in a sample and other discriminable ligands. This test is based on the fact that allergic and symptomatic individuals recognize, by means of their antibodies, epitopes different from those recognized by the antibodies of tolerant individuals on the same specific immunogenic and antigenic macromolecular structure of said pathology. That document also describes the possibility of measuring the evolution of this specificity, in particular in the case of children who are allergic to milk and the change toward the in vivo acquisition of tolerance to milk.
Patent application WO94/29459, “Stress proteins and uses thereof” relates to a stress protein and methods of modulating an “individual” immune response. It also relates to a composition comprising a stress protein joined to another component, such as a fusion protein in which a stress protein is fuse to an antigen. According to the invention, it is possible to modulate the immune response in an individual, such as a human, other mammals or other vertebrates by altering the individual's response to stress protein. By altering the individual's immune response to the stress protein, it is possible to enhance or induce an individual's response to a pathogen or to cancer cells or enhance or induce an up-regulation of an individual's immune status and to decrease an individual's autoimmune response, such as it occurs in some forms of arthritis.
U.S. Pat. No. 6,048,530 “Stress protein-peptide complexes as prophylactic and therapeutic vaccines against intracellular pathogens” describes a family of vaccines that contain stress protein-peptide complexes which, when they are administered to a mammal, are operative to initiate in the mammal a cytotoxic T cell response against cells infected with a pre-selected intracellular pathogen. The patent also discloses the preparation of stress protein and immunogenic stress protein-peptide complexes from infected cells or tissues, the isolation of potentially immunogenic peptides from stress protein-peptide complexes from infected cells or from MHC-peptides complexes. The synthesis of those peptides and the reconstitution of heat shock protein-peptide complexes with synthetic peptides or peptides isolated from heat shock protein-peptide complexes isolated from infected cells is also described. According to said document, the peptides-heat shock protein complexes, when isolated from a eukaryotic cell infected with a pre-selected intracellular pathogen, and then administered to a mammal can stimulate a cytotoxic T cell response against cells infected with the same pathogen.
Patent application WO97/06821 “Heat shock protein-based vaccines and immunotherapies” describes a composition for inducing a therapeutic immune response in a subject, comprising: a) a target antigen; and b) a heat shock protein; wherein the target antigen and the heat shock protein are combined in vitro under conditions wherein binding of target antigen to the heat shock protein occurs to form a target antigen-heat shock protein complex; wherein the administration of the target antigen/heat shock protein complex to the subject induces an immune response comprising a cytotoxic cellular component.
Patent application WO98/23735 “Immune responses using compositions containing stress proteins” describes a vaccine for inducing a cell-mediated cytolytic immune response in a mammal against an antigen. The vaccine is comprising the antigen and all or a portion of stress protein or all or a portion of a protein having an amino acid sequence sufficiently homologous to the amino acid sequence of the stress protein to induce the immune response against the antigen. In one embodiment, the antigen is an antigen of the influenza virus. In another embodiment, the antigen is a tumor-associated antigen. The patent also describes a mixture of known allergenic antigens (allergens) and stress proteins or compositions containing allergens chemically linked or fused to the stress protein. Allergens used in allergen-stress protein fusion proteins are necessarily of a peptidic nature; non peptidic allergens can be used in conjugates containing an allergen and a stress protein or a mixture of allergens and stress proteins. Non limiting examples for allergens include Fel d1 (cat), . . .
Epitope mapping technology is the identification and localization of the specific regions of macromolecules that are recognized by the immune system. An epitope is a small region of a macro molecule that the immune system recognizes and responds to. T cell epitopes are linear fragments of the original protein molecule whereas B cell epitopes can be either linear fragments or folded three-dimensional regions of the intact macro molecule.
Several methods for epitopes mapping have been previously described:
Classical Epitope Mapping
Defined fragments of the cDNA for the antigens of interest are expressed as recombinant (fusion)proteins and probed with autoantisera in various assays such as Western blot or ELISA.
Phage Display Technology
Small random fragments of the cDNA f
Duchateau Jean
Hénot Frédéric
Legon Thierry
Servais Genevieve
Biotech Tools S.A.
Di Nola-Baron Liliana
Merchant & Gould P.C.
Page Thurman K.
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