Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
1997-11-20
2001-03-27
Wessendorf, T. D. (Department: 1627)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C514S021800, C514S002600, C530S351000, C530S350000, C530S324000
Reexamination Certificate
active
06207641
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to an agent for susceptive diseases which contains as an effective ingredient a novel polypeptide that induces the interferon-&ggr; (hereinafter abbreviated as “IFN-&ggr;”) production by immunocompetent cells.
2. Description of the Prior Art
It is known that IFN-&ggr; is a protein which has antiviral-, antioncotic- and immunoregulatory-activities, and which is produced by immunocompetent cells stimulated with antigens or mitogens. Because of these biological activities, IFN-&ggr; was expected to be used as an antitumor agent since its discovery, and is studied energetically in clinical trials as a therapeutic agent for malignant tumors in general, including brain tumors. Commercially available IFN-&ggr; preparations are roughly classified into two groups, i.e. a group of natural IFN-&ggr;s produced by immunocompetent cells and a group of recombinant IFN-&ggr;s produced by transformants, obtained by introducing into microorganisms of the species
Escherichia coli
DNAs which encode the natural IFN-&ggr;s. In the above clinical trials, one of these two groups of IFN-&ggr;s is administered to patients as an “exogenous IFN-&ggr;”.
Among these IFN-&ggr;s, natural IFN-&ggr;s are usually produced by culturing established immunocompetent cells in nutrient culture media supplemented with IFN-&ggr; inducers to form IFN-&ggr;s, and purifying the formed IFN-&ggr;s. It is known that the type of IFN-&ggr; inducers greatly influences the IFN-&ggr; yield, as well as on the ease of IFN-&ggr; purification and the safety of the final IFN-&ggr; containing products. Generally, mitogens such as concanavalin A (Con A),
Lens culinaris, Phytolacca americana,
endotoxin and lipopolysaccharide can be used as an IFN-&ggr; inducer. However, these mitogens have the problems of molecular varieties and quality changes depending on their origins and purification methods, as well as the difficulties in obtaining preparations having a constant IFN-&ggr; inducibility in a desired amount. In addition, most of these mitogens might induce unfavorable side effects when administered to living bodies, and some of them may even cause toxicity, so that it is substantially difficult to induce the IFN-&ggr; production by directly administering IFN-&ggr; inducers to living bodies.
Recently, some pharmaceuticals, which contain as an effective ingredient cytokines such as interferon-&agr;, interferon-&bgr;, TNF-&agr;, TNF-&bgr;, interleukin 2, and interleukin 12, as well as IFN-&ggr;, were developed or are being explored for actual use. These pharmaceuticals can be used as an antitumor agent, antiviral agent, antiseptic or immunoregulatory agent and, if necessary, they can be used together with other medicaments.
Unlike chemically synthesized pharmaceuticals, the aforesaid pharmaceuticals have as the greatest feature the characteristic that they can be administered to patients for a relatively-long period of time without inducing serious side effects, but they also have the demerits that their therapeutic effects are generally relatively-low, and they could not substantially remit and cure diseases when used alone, with the results varying depending on the types of diseases and symptoms to be treated. Therefore, these pharmaceuticals are now used as a supplemental agent for chemically synthesized agents in the treatment of serious diseases such as malignant tumors or used to prolong the patients' life.
SUMMARY OF THE INVENTION
In view of the foregoing, the object of the present invention is to provide a pharmaceutical which exerts a strong effect and which can be administered to patients for a relatively long period of time without inducing serious side effects.
The object of the present invention is attained by an agent for susceptive diseases which contains as an effective ingredient a polypeptide having either the amino acid sequence of SEQ ID NO:1 (where the symbol “Xaa” represents “isoleucine” or “threonine”) or its homologous amino acid sequence, and inducing the IFN-&ggr; production by immunocompetent cells.
SEQ ID NO:1:
Tyr Phe Gly Lys Leu Glu Ser Lys Leu Ser Val Ile Arg Asn Leu Asn
1 5 10 15
Asp Gln Val Leu Phe Ile Asp Gln Gly Asn Arg Pro Leu Phe Glu Asp
20 25 30
Met Thr Asp Ser Asp Cys Arg Asp Asn Ala Pro Arg Thr Ile Phe Ile
35 40 45
Ile Ser Met Tyr Lys Asp Ser Gln Pro Arg Gly Met Ala Val Thr Ile
50 55 60
Ser Val Lys Cys Glu Lys Ile Ser Xaa Leu Ser Cys Glu Asn Lys Ile
65 70 75 80
Ile Ser Phe Lys Glu Met Asn Pro Pro Asp Asn Ile Lys Asp Thr Lys
85 90 95
Ser Asp Ile Ile Phe Phe Gln Arg Ser Val Pro Gly His Asp Asn Lys
100 105 110
Met Gln Phe Glu Ser Ser Ser Tyr Glu Gly Tyr Phe Leu Ala Cys Glu
115 120 125
Lys Glu Arg Asp Leu Phe Lys Leu Ile Leu Lys Lys Glu Asp Glu Leu
130 135 140
Gly Asp Arg Ser Ile Met Phe Thr Val Gln Asn Glu Asp
145 150 155
The present invention was made based on the finding of a novel polypeptide which induces the IFN-&ggr; production by immunocompetent cells. The present inventors studied cytokines produced from mammalian cells and have found that there exists an IFN-&ggr; production inducing substance in mouse liver which was previously treated with a lipopolysaccharide and inactivated whole cells of Corynebacterium. They isolated the substance by a variety of purification methods using column chromatography as a main technique, studied the properties and
Fukuda Shigeharu
Kurimoto Masashi
Tanimoto Tadao
Torigoe Kakuji
Browdy and Neimark
Kabushiki Kaisha Hayashibara Seibutsu Kagaku Kenkyujo
Wessendorf T. D.
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