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WO2018164295A1 - Composition pharmaceutique contenant de la cystatine a destinée au traitement de maladies colorectales - Google Patents

Composition pharmaceutique contenant de la cystatine a destinée au traitement de maladies colorectales Download PDF

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Publication number
WO2018164295A1
WO2018164295A1 PCT/KR2017/002514 KR2017002514W WO2018164295A1 WO 2018164295 A1 WO2018164295 A1 WO 2018164295A1 KR 2017002514 W KR2017002514 W KR 2017002514W WO 2018164295 A1 WO2018164295 A1 WO 2018164295A1
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WO
WIPO (PCT)
Prior art keywords
colorectal
cystatin
disease
present
pharmaceutical composition
Prior art date
Application number
PCT/KR2017/002514
Other languages
English (en)
Inventor
Myung Jun Chung
Original Assignee
Cell Biotech Co., Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cell Biotech Co., Ltd. filed Critical Cell Biotech Co., Ltd.
Publication of WO2018164295A1 publication Critical patent/WO2018164295A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/005—Enzyme inhibitors
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17—Amino acids, peptides or proteins
    • A23L33/18—Peptides; Protein hydrolysates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/55—Protease inhibitors
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2200/00—Function of food ingredients
    • A23V2200/30—Foods, ingredients or supplements having a functional effect on health
    • A23V2200/308—Foods, ingredients or supplements having a functional effect on health having an effect on cancer prevention
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Definitions

  • the present invention relates to a pharmaceutical composition for treating colorectal disease, which contains cystatin A.
  • Colorectal diseases refer to a group of various diseases that occur in the colon which include colorectal cancer, colitis, irritable bowel syndrome, Crohn's disease and the like.
  • the number of patients with colorectal diseases is increasing in modern times, due to frequent stress, Westernized eating habits, and drinking.
  • colorectal cancer is the second most common cancer in cancer deaths, accounting for about 13% of all cancers. It was reported that about 50,310 people died of colorectal cancer annually and 136,830 cases of new colorectal cancer occur in the United States. In South Korea, the death rate of colorectal cancer is the fourth highest following lung, liver, and stomach cancer.
  • colorectal cancer The incidence of colorectal cancer is increasing which accounts for 12.9% of all cancers in 2012 compared with 5.8% in 1980, 6.1% in 1985, 8.2% in 1995, and 11.2% in 2002. And despite a decrease in the death rate of gastric cancer, liver cancer and cervical cancer in 2011 compared with 1999, the death rate of colorectal cancer has increased by 5.6%.
  • many chemical anticancer drugs have been developed for the treatment of colorectal cancer, such as fluoropyrimidine-based drugs(fluorouracil, tegafur-uracil, capecitabine and the like), irinotecan, oxaliplatin, and targeted therapeutic agents(bevacizumab, cetuximab and the like).
  • fluoropyrimidine-based drugs fluorouracil, tegafur-uracil, capecitabine and the like
  • irinotecan irinotecan
  • oxaliplatin oxaliplatin
  • targeted therapeutic agents bevacizuma
  • cystatin is a substance that inhibits the activity of intracellular proteases, and is currently classified into family 1 (cystatin-alpha, and cystatin-beta) that is present in cells, secretory family 2 (cystatin C, cystatin S, egg white cystatin, and milk cystatin), family 3 (kininogen), and the like.
  • Cystatin-alpha exists in leukocyte, epithelial tissue of epidermis, digestive tracts, vagina, and etc., and the like, and functions to protect the human body from the invasion of pathogenic microbes. Cystatin-beta is present in most cytosols, and functions to inhibit the activity of proteases to thereby prevent viral infections.
  • Egg white cystatin also helps prevent viral infections, and a substance having the same function as that of egg white cystatin is oryzacystatin that is found in rice seeds.
  • Cystatin C is a functional protein that is produced in certain amounts every moment by all the cells of the human body and functions to prevent the onset of diseases and maintain normal physiology, and particularly, it is known to play an important role in the defense function of the immune system. Elucidation of the secretory mechanism and function of cystatin D is still insufficient.
  • cystatin the effects of cystatin A on prostate cancer (US 2003-0113762 A1), the effects of cystatin C on inflammation (US 2016-0245824 A1), the effects of cystatin SN on colorectal cancer (CN 103740854 B) and the like.
  • cystatin A the effects of cystatin A on prostate cancer
  • cystatin C the effects of cystatin C on inflammation
  • cystatin SN the effects of cystatin SN on colorectal cancer
  • the technology for the treatment of cystatin A in colorectal cancer has not been developed sufficiently.
  • the present invention is directed to a pharmaceutical composition for treating colorectal disease, which contains cystatin A.
  • the composition of the present invention has been demonstrated to have significant effects on the inhibition of colorectal cancer growth, and thus will be effectively used as a therapeutic agent against colorectal cancer in the medical field.
  • the present invention has been made in order to solve the above-described problems occurring in the prior art, and is directed to a pharmaceutical composition for treating colorectal disease, which contains cystatin A.
  • cystatin refers to a substance that inhibits the activity of intracellular proteases. Cystatin is currently classified into family 1 (cystatin-alpha, and cystatin-beta) that is present in cells, secretory family 2 (cystatin C, cystatin D, cystatin S, egg white cystatin, and milk cystatin), family 3 (kininogen), and the like. Cystatin-alpha exists in leukocytes, the epithelial tissue of epidermis, digestive tracts, vagina, and etc., and the like, and functions to protect the human body from the invasion of pathogenic microbes.
  • Cystatin-beta is present in most cytosols, and functions to inhibit the activity of proteases to thereby prevent viral infections.
  • Egg white cystatin also helps prevent viral infections, and a substance having the same function as that of egg white cystatin is oryzacystatin that is found in rice seeds.
  • Cystatin C is a functional protein that is produced in certain amounts every moment by all the cells of the human body and functions to prevent the onset of diseases and maintain normal physiology, and particularly, it plays an important role in the defense function of the immune system.
  • blood cystatin C levels increase in various pathologies. If blood cystatin C levels are 1 mg/L or higher, the incidence rate of heart attack, stroke, sudden cardiac death or chronic renal failure increases as the value increases. Elucidation of the secretory mechanism and function of cystatin D is still insufficient.
  • the term “colorectal disease” refers to a group of various diseases that occur in the colon.
  • the colorectal disease is preferably colorectal cancer, colorectal polyp, colitis, ischemic bowel disease, dysentery, intestinal vascular dysplasia, diverticulosis, irritable bowel syndrome, or Crohn's disease, but is not limited thereto. More preferably, the colorectal disease is colorectal cancer.
  • “pharmaceutical composition” refers to a composition to be administered for a specific purpose.
  • the pharmaceutical composition of the present invention contains, as active ingredients, cystatin A.
  • the pharmaceutical composition of the present invention may contain protein and a pharmaceutically acceptable carrier, excipient or diluent, which are involved therein.
  • the "pharmaceutically acceptable" carrier or excipient means one approved by a regulatory agency of the Federal or a state government, or one listed in the pharmacopoeia or other generally recognized pharmacopoeia for use in vertebral animals, and more particularly in humans.
  • the pharmaceutical composition of the present invention can be in the form of suspensions, solutions, or emulsions, in oily or aqueous vehicles, and can be in the form of solid or semi-solid, preferably liquid.
  • the pharmaceutical composition of the present invention can contain formulatory agents such as suspending, stabilizing, solubilizing, and/or dispersing agents, and can be sterilized.
  • the pharmaceutical composition can be stable under the conditions of manufacture and storage and can be preserved against the contaminating action of microorganisms such as bacteria and fungi.
  • the pharmaceutical composition of the present invention can be in sterile powder form for reconstitution with a suitable vehicle before use.
  • the pharmaceutical composition can be presented in unit dose form, in microneedle patch, in ampoules, or other unit-dose containers, or in multi-dose containers.
  • the pharmaceutical composition can be stored in a freeze-dried (lyophilized) condition requiring only the addition of sterile liquid carrier, for example, water for injection immediately prior to use.
  • sterile liquid carrier for example, water for injection immediately prior to use.
  • Extemporaneous injection solutions and suspensions can be prepared from sterile powders, granules or tablets.
  • the pharmaceutical composition of the present invention may be formulated as liquid or contained as microspheres in liquids.
  • excipients that are suitable for the pharmaceutical composition of the present invention may include preservatives, suspending agents, stabilizers, dyes, buffers, antibacterial agents, antifungal agents, and isotonic agents, for example, sugars or sodium chloride.
  • stabilizer refers to a compound optionally used in the pharmaceutical composition of the present invention in order to increase storage life.
  • additional stabilizers may be sugars, amino acids or polymers.
  • the pharmaceutical composition of the present invention can comprise one or more pharmaceutically acceptable carriers.
  • the carrier can be a solvent or dispersion medium.
  • Non-limiting examples of pharmaceutically acceptable carriers include water, saline, ethanol, polyol (e.g., glycerol, propylene glycol and liquid polyethylene glycol), oils, and suitable mixtures thereof.
  • Non-limiting examples of sterilization techniques that are applied to the pharmaceutical composition of the present invention include filtration through a bacterial-restraining filter, terminal sterilization, incorporation of sterilizing agents, irradiation, sterilization gas irradiation, heating, vacuum drying, and freeze drying.
  • “food composition” can be used in various foods, for example, beverages, gums, teas, vitamin complexes, health supplement foods or the like, and may be used as pills, powders, granules, infusions, tablets, capsules or beverages, and the content (wt%) of the food composition in foods is not limited.
  • the food composition of the present invention may contain conventional food additives known in the art, for example, flavorings, colorants, fillers, stabilizers and the like.
  • the food composition according to the present invention is not particularly limited, as long as it is a composition containing, as essential ingredients, cystatin A.
  • the food composition of the present invention may additionally contain various flavorings or natural carbohydrates as in conventional beverages.
  • the natural carbohydrates include conventional sugars, such as monosaccharides (e.g., glucose, fructose, etc.), disaccharides (e.g., maltose, sucrose, etc.), polysaccharides (e.g., dextrin, cyclodextrin, etc.), and sugar alcohols such as xylitol, sorbitol, erythritol or the like.
  • sugar alcohols such as xylitol, sorbitol, erythritol or the like.
  • flavorings that may be used in the present invention include natural flavorings (thaumatin, stevia extracts, such as rebaudioside A, glycyrrhizin, etc.) and synthetic flavorings (saccharin, aspartame, etc.).
  • the natural carbohydrate is used in an amount of about 1-20 g, preferably about 5-12 g, based on 100 mL of the composition of the present invention.
  • the food composition of the present invention may contain various nutrients, vitamins, minerals (electrolytes), flavorings such as synthetic flavorings and natural flavorings, colorants, extenders (cheese, chocolate, etc.), pectic acid and its salt, alginic acid and its salt, organic acids, protective colloidal thickeners, pH adjusting agents, stabilizers, preservatives, glycerin, alcohol, carbonizing agents as used in carbonated beverages, etc.
  • Such components may be used individually or in combination. Although the percentage of such additives is not of great importance, it is generally selected in a range of 0 to about 20 parts by weight based on 100 parts by weight of the composition of the present invention.
  • “administration” means introducing the composition of the present invention into a patient by any suitable method.
  • the composition of the present invention may be administered by any general route, as long as it can reach a target tissue.
  • the composition of the present invention may be administered orally, intraperitoneally, intravenously, intramuscularly, subcutaneously, intradermally, intranasally, intrapulmonarily, intrarectally, intracavitally or intrathecally.
  • the pharmaceutical composition of the present invention which contains, as active ingredients, cystatin A, is administered intravenously as a liquid formulation or administered as orally as a powder, tablet, capsule or liquid formulation, but is not limited thereto.
  • a method for treating colorectal disease according to the present invention may comprise administering a pharmaceutically effective amount of the pharmaceutical composition.
  • the effective amount can be determined depending on various factors, including the kind of disease, the severity of the disease, the kinds and contents of active ingredient and other ingredients in the composition, the kind of formulation, the patient’s age, body weight, general health condition, sex and diet, the time of administration, the route of administration, the secretion rate of the composition, the period of treatment, and other drugs that are concurrently used.
  • the present invention provides a method of treating colorectal disease, the method comprising administering to a patient in need thereof a pharmaceutical composition containing an effective amount of cystatin A.
  • the colorectal disease is any one or more selected from the group consisting of colorectal cancer, colorectal polyp, colitis, ischemic bowel disease, dysentery, intestinal vascular dysplasia, diverticulosis, irritable bowel syndrome, or Crohn's disease.
  • the colorectal disease is colorectal cancer.
  • the present invention provides a use of cystatin A thereof, for preparation of a medicament for treatment of colorectal disease.
  • the colorectal disease is any one or more selected from the group consisting of colorectal cancer, colorectal polyp, colitis, ischemic bowel disease, dysentery, intestinal vascular dysplasia, diverticulosis, irritable bowel syndrome, or Crohn's disease.
  • the colorectal disease is colorectal cancer.
  • the present invention provides a pharmaceutical composition for treating colorectal disease, which contains, as active ingredients, cystatin A.
  • the colorectal disease is any one or more selected from the group consisting of colorectal cancer, colorectal polyp, colitis, ischemic bowel disease, dysentery, intestinal vascular dysplasia, diverticulosis, irritable bowel syndrome, or Crohn's disease.
  • the colorectal disease is colorectal cancer.
  • the present invention provides a food composition for alleviating colorectal disease, which contains, as active ingredients, cystatin A.
  • the colorectal disease is any one or more selected from the group consisting of colorectal cancer, colorectal polyp, colitis, ischemic bowel disease, dysentery, intestinal vascular dysplasia, diverticulosis, irritable bowel syndrome, or Crohn's disease.
  • the colorectal disease is colorectal cancer.
  • the number of patients with colorectal diseases is increasing in modern times, due to frequent stress, Westernized eating habits, and drinking.
  • colorectal cancer is the second most common cancer in cancer deaths.
  • the pharmaceutical composition of the present invention which contains cystatin A, exhibits a significantly increased inhibitory effect against colorectal cancer compared to when cystatin is not used.
  • the pharmaceutical composition of the present invention will be effectively used as a therapeutic agent against colorectal cancer in the medical field.
  • FIG. 1 is a schematic view showing culture of cancer cell line and cystatin treatment processes of the present invention.
  • FIG. 2 is a graph showing that the growth of colorectal cancer cells was inhibited by cystatin treatment to the colorectal cancer cell line HCT116 of the present invention.
  • FIG. 3 is a graph showing that the growth of colorectal cancer cells was inhibited by cystatin treatment to the colorectal cancer cell line DLD-1 of the present invention.
  • FIG. 4 is a graph showing that the growth of colorectal cancer cells was inhibited by cystatin treatment to the breast cancer cell line MCF7 of the present invention.
  • cystatin A or cystatin D When the cystatin A or cystatin D was administered, the growth of the cancer cells (HCT116 and DLD-1 cells) was significantly inhibited compared to when the cystatin SN or cystatin SA was administered. However, in the case of breast cancer cell line (MCF7), every types of cystatin used in experiments had no great effect on the inhibition of the growth of cancer cells. From these results, it was found that cystatin A specifically inhibited the growth of colorectal cancer cells.
  • HCT116 and DLD-1 colorectal cancer cell lines
  • MCF7 breast cancer cell line
  • FIG. 1 is schematic views showing the culture of cancer cell line and cystatin treatment processes.
  • cystatin A or cystatin D when the cystatin A or cystatin D was administered, the growth of the cancer cells (HCT116 and DLD-1 cells) was significantly inhibited compared to when the cystatin SN or cystatin SA was administered.
  • MCF7 breast cancer cell line
  • every types of cystatin used in experiments had no great effect on the inhibition of the growth of cancer cells. From these results, it was found that cystatin A or cystatin D specifically inhibited the growth of colorectal cancer cells.
  • the present invention is directed to a pharmaceutical composition for treating colorectal disease, which contains cystatin A.
  • the composition of the present invention has been demonstrated to have significant effects on the inhibition of colorectal cancer growth, and thus will be effectively used as a therapeutic agent against colorectal cancer in the medical field.

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  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Polymers & Plastics (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Molecular Biology (AREA)
  • Mycology (AREA)
  • Nutrition Science (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)

Abstract

La présente invention concerne une composition pharmaceutique destinée au traitement de maladies colorectales, contenant de la cystatine A. La composition pharmaceutique de la présente invention, qui contient de la cystatine A, présente un effet inhibiteur contre le cancer colorectal significativement augmenté par comparaison avec le cas où il n'y a pas d'utilisation de cystatine. Ainsi, la composition pharmaceutique de la présente invention sera efficacement utilisée dans le domaine médical comme agent thérapeutique contre le cancer colorectal.
PCT/KR2017/002514 2017-03-06 2017-03-08 Composition pharmaceutique contenant de la cystatine a destinée au traitement de maladies colorectales WO2018164295A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR10-2017-0028222 2017-03-06
KR1020170028222A KR101791876B1 (ko) 2017-03-06 2017-03-06 시스타틴 a를 유효성분으로 포함하는 대장질환 치료용 약학조성물

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WO2018164295A1 true WO2018164295A1 (fr) 2018-09-13

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Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101915950B1 (ko) 2018-01-09 2018-11-07 주식회사 쎌바이오텍 시스타틴을 발현 및 분비하는 위장관 질환 치료 약물 전달용 미생물 및 그를 포함하는 위장관 질환 예방 또는 치료용 약제학적 조성물

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080019910A1 (en) * 2004-03-30 2008-01-24 Romer Maria U Cancer Treatment and Cancer Treatment Efficacy Prediction by Blocking and Detecting Protease Inhibitors
WO2008054635A2 (fr) * 2006-11-02 2008-05-08 Viral Genetics, Inc. Proteines destinees a etre utilisees dans le diagnostic et le traitement d'infections et de maladies

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080019910A1 (en) * 2004-03-30 2008-01-24 Romer Maria U Cancer Treatment and Cancer Treatment Efficacy Prediction by Blocking and Detecting Protease Inhibitors
WO2008054635A2 (fr) * 2006-11-02 2008-05-08 Viral Genetics, Inc. Proteines destinees a etre utilisees dans le diagnostic et le traitement d'infections et de maladies

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
BIAN ET AL.: "Cathepsin B promotes colorectal tumorigenesis, cell invasion, and metastasis", MOLECULAR CARCINOGENESIS, vol. 55, no. 5, 2016, pages 671 - 687, XP055549480 *
KOS ET AL.: "Cysteine proteinase inhibitors stefin A, stefin B, and cystatin C in sera from patients with colorectal cancer: relation to prognosis", CLINICAL CANCER RESEARCH, vol. 6, 2000, pages 505 - 511, XP055549488 *
LI ET AL.: "Overexpression of stefin A in human esophageal squamous cell carcinoma cells inhibits tumor cell growth, angiogenesis, invasion, and metastasis", CLINICAL CANCER RESEARCH, vol. 11, no. 24, 2015, pages 8753 - 8762, XP055549472 *

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