Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...
Reexamination Certificate
1999-03-04
2001-12-25
Smith, Lynette R. F. (Department: 1645)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving antigen-antibody binding, specific binding protein...
C435S007200, C435S174000, C435S177000, C435S921000, C435S922000, C424S184100, C424S274100, C530S350000, C530S395000, C530S397000, C530S399000, C530S402000, C530S405000, C530S406000, C530S408000, C530S410000
Reexamination Certificate
active
06333164
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a fungal antigen effective for infectious diseases caused by fungi, which are pathogenic microorganisms, having cell wall, for prevention or treatment of allergoses, and for diagnosis of diseases caused by fungi, and a process for producing the same.
2. Discussion of the Related Art
It has been known that fungi infect vertebrates such as humans and animals to cause all kinds of diseases. For example, superficial mycosis is caused in human skin, oral, or the like; systemic mycosis is caused in internal organs, brain, or the like, and similar infectious diseases are also caused to animals such as pets and domestic animals. Among them, Candida, such as
Candida albicans
, Cryptococcus, such as
Cryptococcus neoformans
, Aspergillus, such as
Aspergillus fumigatus, Pneumocystis carinii
, or the like have been known as major causative fungi which cause systemic mycosis by infecting humans. Candida which infects skin, oral, vagina, or the like, and Dermatophytes such as
Trichophyton mentagrophytes
and
Trichophyton rubrum
which infects skin of hands, feet, or the like have been taken for major causative fungi for superficial mycosis.
A lot of Dermophytes are fungi which cause infectious diseases to domestic animals, and the like, and it has been known that Microsporum such as
Microsporum canis
and
Microsporum gypseum
are such fungi other than Trichophyton, such as
Trichophyton verrucosum
mentioned above. In addition to these fungi, a wide variety of fungi occur in the living environment, and are assumed to infect humans and animals. Furthermore, recently, by the frequent use of a wide range of antibiotics, use of immunosuppressants, use of immunosuppressive anticancer agents, etc., patients administered with these drugs have become immunocompromised hosts, and opportunistic infection with fungi of low pathogenicity have been increased in normal individuals administered therewith. Also, AIDS patients suffer from frequent onset of thrush and complications of various mycoses. Patients on treatment with intravascular catheter indwelling, especially intravenous hyperalimentation (IVH), are likely to develop infectious diseases caused by fungi, especially with Candida owing to catheter.
On the other hand, allergoses, typically including asthma, atopic dermatitis, and allergic rhinitis, have been increasing dramatically, among which a very large number of allergoses are caused by fungi.
As for a lot of allergoses, because of sensitization with a causative antigen of its disease, an IgE antibody (reagin antibody) specific to the antigen as an allergen is produced in serum and tissue, so that the IgE antibody is bound to mast cells and basophil receptors. When re-exposed to the same antigen, the IgE bound to the cells is crosslinked with the antigen on the cell surface, thereby resulting in physiological effects of IgE-antigen interaction. These physiological effects are exhibited via a release of chemical mediators, such as histamine, serotonin, heparin, eosinophilic chemotactic factor, and various leukotrienes. These effects can be systemic or topical, depending on the route of an antigen entering the body and the pattern of IgE sedimentation on the mast cells or basophils.
The systemic symptoms include anaphylactic shock, which causes intravascular IgE-basophil response to the antigen. As a consequence, smooth muscle contraction and capillary dilation take place as major changes, thereby resulting in symptoms such as eruption, vomiting, diarrhea, and dyspnea. In more severe cases, it may lead to death. In addition, the topical symptoms generally develop on the epithelium surface at the site of an antigen entering the body as shown by reddening and papules. When bronchiolar smooth muscle contraction develops as a topical symptom, it is manifested as bronchial asthma.
As the causative strains for causing allergoses, there have been known Penicillium, Candida, Aspergillus, Alternaria, Cladosporium, Malassezia, Botrytis, Mucor, Rhizopus, Aureobasidium, Fusarium, Trichoderma, Helminthosporium, Neurospora, Wallemia, Rhodotorula, and Trichophyton.
As the therapy for fungal infections, a treatment with an antifungal agent is generally employed. A large number of drugs for superficial mycoses have been developed, and some excellent drugs for systemic infections are available. In terms of efficacy, toxicity, adverse reactions, etc., however, their effects are unsatisfactory. For example, amphotericin B that has long been used, causes various adverse reactions, including serious renal dysfunction. Although various azole antifungal agents, typically including fluconazole, have been developed, infections are highly likely to recur because their action is static. Also, resistant strains are emerging due to frequent use. As the resistant strains emerge, the cross-resistance takes place, because many of the antifungal agents presently in practical use possess similar action mechanisms, which can pose a major problem. In cases of superficial mycoses, various therapeutic drugs have been developed, but none can be said to be satisfactory, because it requires a long-term treatment period and recurrence is repeated. Therefore, a development of a further improved drug has been in demand. Moreover, since a treatment with topical preparations only would be unsatisfactory for some superficial mycoses, e.g., nail tinea, these superficial mycoses would require systemic medication such as griseofulvin. In this case, long-term administration would be necessitated, which can cause various adverse reactions by the drugs. Also, as in superficial mycoses and AIDS-related thrush, since repetitive infection is caused, there is a major problem in terms of costs, even if an effective antifungal agent is developed. As described above, a treatment with an antifungal agent has various problems.
The living body naturally possesses an ability to protect against infection by fighting against such foreign-invading microorganisms. Vaccines utilize this ability. The prevention against infection with pathogenic bacteria has been carried out by vaccines and has been long used with fair efficacy. For such vaccines against bacterial infectious diseases, attenuated bacteria (
Mycobacterium tuberculosis
), killed bacteria (
Vibrio cholerae
), toxoids (
Corynebacterium diphtheriae, Clostridium tetani
), or purified antigens from capsular polysaccharides on cell surface (
Bordetella pertussis, Streptococcus pneumoniae
, influenza virus,
Neisseria meningitidis
) are employed as antigens. The vaccines provide an ability to protect against infection to the host by antibodies against antigenic molecules of the pathogen and by cellular immunity. It is considered that the antibodies serve to neutralize the toxic substances secreted by pathogens, and to prevent pathogens from invading host cells by binding to the cell surface molecules of the pathogen. In the cellular immunity, CD4+ cells and CD8+ T cells play a key role for recognizing the antigenic molecules of the pathogen and activating a protection reaction specific to the pathogen. Immunogenic substances, which are antigenic molecules possessed by the pathogens, have been isolated and identified, and some studies using these immunogens as sensitizing antigens (vaccines) have been made. In such cases, capsular polysaccharides, which are cell surface molecules as described above, are commonly used as immunogens.
An extremely large number and many kinds of fungi are present in the environment, and almost all vertebrates are sensitized with these fungi. Also, a large number of fungi are commonly present in the living bodies. The vertebrates are, therefore, generally provided with various immunological reactions for body protection against these fungi. Immunological reactions which have important roles against fungal infections show the phagocytosis and fungicidal actions of activated macrophages and polymorphonuclear leukocytes (PMN) and play a main role, and are also known to contribute to
Endo Masahiro
Kato Ikunoshin
Mizutani Shigetoshi
Takesako Kazutoh
Baskar Padma
Birch & Stewart Kolasch & Birch, LLP
Smith Lynette R. F.
Takara Shuzo Co. Ltd.
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