Drug – bio-affecting and body treating compositions – Whole live micro-organism – cell – or virus containing – Bacteria or actinomycetales
Reexamination Certificate
1997-11-12
2001-05-29
Prats, Francisco (Department: 1651)
Drug, bio-affecting and body treating compositions
Whole live micro-organism, cell, or virus containing
Bacteria or actinomycetales
C424S244100, C424S093440, C424S093500, C424S274100, C424S548000, C435S254100, C435S253400, C514S054000, C514S777000, C514S059000, C514S060000
Reexamination Certificate
active
06238660
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a substance that can induce interleukin-12 in vivo, and to a medical composition containing the same.
2. Description of the Related Art
Interleukin-12 (IL-12) was originally found as one of cytokinins that can activate NK cells. Subsequent studies revealed that it also promoted growth of and activated T cells that had cytotoxicity specific to tumor cells (Killer T cells), and further it promoted the production of interferon &ggr; (IFN &ggr;) that stimulated activation of killer T cells. Thus IL-12 has attracted attention as a substance effective in treating human cancer patients.
Recently, large-scale production of IL-12 by using a gene manipulation technique was realized in the U.S. (Recombinant IL-12 (rt-IL-12)). Following that, in order to directly deliver IL-12 to cancer cells, a method for directly introducing the IL-12 producing gene into tumor cells, by using gene introduction techniques, has been investigated.
However, sensitivity of rt-IL-12 used in the method is low and administration of a large-amount is needed, for example, to treat human cancer. Such large-amount dosage causes various side effects including fever and inappetence. Besides these serious side effects, several problems regarding this method are pointed out, that is, the gene manipulation procedure is so complicated that it is labor intensive and lacks economical feasibility.
For using IL-12 to prevent tumor growth or cause regression, there are two methods; one is to externally administrate IL-12, and the other is to induce in vivo production of IL-12. Such induced IL-12 does not raise abnormal immune response, thereby resolving intrinsic problems of rt-IL-12. At the same time, such IL-12 is highly effective, thus extensive tumor loss regression effect can be expected. However, before the instant invention an effective substance that could induce IL-12 of its own in vivo had not been found.
SUMMARY OF THE INVENTION
In view of the above circumstances, it is an object of the present invention to provide a method for inducing IL-12 in vivo in a tumor bearing patient and a substance having such an induction effect, and further to provide a medical composition obtained by utilizing the same.
According to the present invention, there is provided an interleukin-12 inducer containing activated hemicellulose (AHCC) and a medical composition containing the same.
DETAILED DESCRIPTION OF THE INVENTION
Hereunder, the detailed description is made of the present invention.
Activated HemiCellulose Compound (AHCC) of the present invention is a known compound as a biologically active substance which is obtained by enzyme treatment of plant fiber existing in the cell wall of fungal mycelia. Preferable AHCCs for use in the present invention are selected from (1) &bgr;-D-glucan, (2) &agr;-D-glucan, and (3) a mixture of &bgr;-D-glucan and &agr;-D-glucan. AHCC contains in addition to heteroglucan such as &bgr;-(1-3)D-glucan, &bgr;-(1-6)D-glucan and &agr;-(1-4)D-glucan; peptidoglycan, proteoglucan, lectin, nucleic acid and indigestive polysaccharide. Dojin News, No. 34, pages 2-4 (1985); the entire content of which is hereby incorporated by reference.
However, it had not been previously known that AHCC could induce IL-12, until the fact was newly found by the present inventor.
The IL-12 inducer of the present invention may consist only of the above described AHCC, but preferably further contains components of fungal mycelium (
Eubasido
-
mycetes
). Examples of such components of mushroom's mycelium include PSK that is a component of a polypore's mycelium (Polyporacede) and used as a known anti-cancer agent, SPG that is a component of
Schizophyllum commune mycelium's mycelium,
and lentinan that is a component of a shiitake's mycelium (
Lentinula edodes
), but are not limited thereto.
Further, such components of fungal mycelium include, for example, that of agaricus,
Ganoderma lucidum,
ningyotake, kawariharatake, niousimeji, kabenoanatake,
Griforia frondosa, Hericium erinaceum,
an oyster fungal (
Pleurotus ostreatus
), mannnenntake (
Ganoderma lucidum
),
Panellus serotinus,
kobutake,
Lenzites betulina,
a matsu-take (
Tricholoma matsutake
), bekkoutake, nametake and
Frammulina velutipes.
The IL-12 inducer of the present invention may be composed of only above described AHCC and components of fungal mycelium, but preferably contains bacterial components of hemolytic streptococci in addition to the above. Examples of such bacterial components of hemolytic streptococci include, OK-432 that is a known anti-cancer agent, but are not limited thereto.
These are known substances as biological response modifiers (BRMs).
It has been revealed that in progressed cancer or end-stage cancer, tumor regression or disappearance could not be obtained by established conventional treatments of modern medicine such as surgery, administration of an anti-cancer agent, radiotherapy and hormonotherapy. On the other hand, the IL-12 inducer of the present invention is effective for tumor regression and disappearance in progressed or end-stage cancer. Effectiveness can be determined by, for example, assay of body fluid or parts, NMR, surgery or palpitation. This fact was newly discovered by the present inventor. This is the first unique effect of the present invention.
No side effects were found in the administration of the IL-12 inducer of the present invention. Rt-IL-12 produced by the conventional gene manipulation method has low sensitivity and therefore requires administration in a large volume, which often induces various side effects and exerts upon patients serious damage. On the other hand, the reason why there is no concern for side effects, is because the IL-12 inducer of the present invention can activate the IL-12 production ability naturally existing in a living body as its basic action mechanisms, it is not necessary to externally administer a substance causing side effects.
This fact is newly found by the present inventor and is the second unique effect of the present invention.
The medical composition of the present invention contains the above described IL-12 inducer as the main component. The medical composition of the present invention can be used, for example, as an anti-cancer agent but not limited thereto.
The formulation of the medical composition of the present invention to be administered to a human or animal is not specifically limited. The medical composition of the present invention may be, for example, retained on carriers and suitably prepared into various formulations commonly used in medicine.
As such carriers, at least one selected from solid, semi-solid or liquid diluent, filler and other support for formulation may be used at a ratio of for example, 0.1% to 99.5%, preferably 0.5% to 90%. The medical composition of the present invention may be safely administered perorally or parenterally. The route of parenteral administration includes local administration such as intratissue administration, subcutaneous administration, intramuscular administration, intra arterial/intravenous administration and per rectum administration. Formulations suitable for the above administration routes may be prepared using known practical means.
For example, when used as an anti-cancer agent, the dosage is preferably determined according to age, body weight, administration route used, type of disease and severity. In the case of administration for human patients, it is, for example, generally administered perorally at a dosage of 100 to 20,000 mg/day as the active compound, preferably 1,000 to 10,000 mg/day as the active compound. For parenteral administration, the dosage largely differs according to the administration route, but in general, 100 to 1,000 mg/day, preferably 200 to 500 mg/day may be used. According to each case, a lower dosage may be enough, or a larger dosage may be required. Dosage can be divided into two to four doses per day. Depending on the patient and specific constituents of the anticancer formulation,
Prats Francisco
Sughrue Mion Zinn Macpeak & Seas, PLLC
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