CN1708315A - Anti-tumor combinations comprising proteins and chemotherapeutics - Google Patents

Anti-tumor combinations comprising proteins and chemotherapeutics Download PDF

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Publication number
CN1708315A
CN1708315A CNA2003801024658A CN200380102465A CN1708315A CN 1708315 A CN1708315 A CN 1708315A CN A2003801024658 A CNA2003801024658 A CN A2003801024658A CN 200380102465 A CN200380102465 A CN 200380102465A CN 1708315 A CN1708315 A CN 1708315A
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CN
China
Prior art keywords
protein
fluorouracil
cyclophosphamide
doxorubicin
treatment
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
CNA2003801024658A
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Chinese (zh)
Inventor
A·巴尔托雷利
D·孔卡斯
A·阿克艾基拉
C·莫尔
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Zetesis SpA
Original Assignee
Zetesis SpA
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.)
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Publication date
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Publication of CN1708315A publication Critical patent/CN1708315A/en
Pending legal-status Critical Current

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    • 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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • 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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/1703—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • A61K38/1709—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/37—Digestive system
    • A61K35/407—Liver; Hepatocytes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Cell Biology (AREA)
  • Developmental Biology & Embryology (AREA)
  • Physiology (AREA)
  • Virology (AREA)
  • Nutrition Science (AREA)
  • Organic Chemistry (AREA)
  • Marine Sciences & Fisheries (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

Pharmaceutical compositions containing: a. goat liver perchloric extract containing the protein UK 114, b. cyclophosphamide; c. doxorubicin or other anthracyclins; d. 5-fluorouracil, in the form of combination for the simultaneous, separated or sequential use in chemotherapy.

Description

Comprise the antineoplastic combination of protein and chemotherapeutics
The present invention relates to the compositions of combining form, said composition contains:
A. Hepar Caprae seu ovis (goat liver) the perchloric acid extraction thing that contains protein UK 114;
B. cyclophosphamide;
C. doxorubicin or other anthracyclines;
D.5-fluorouracil,
Simultaneously, be used for amic therapy method respectively or successively.
The invention still further relates to protein UK 114 or contain this proteinic Hepar Caprae seu ovis perchloric acid extraction thing is used for making up with standard chemotherapy regimen the medicine of Synergistic treatment cancer in preparation purposes.
Treat cancer with the chemotherapeutics that can get at present and need following standard scheme usually: wherein multiple medicine makes up according to predetermined dosage regimen, and wherein said predetermined dosage regimen is in order to make treatment and to reply optimization and reducing chemical sproof appearance simultaneously and toxic and side effects and formulating.
In these therapeutic schemes some determined for many years, and is the part of technical staff's knowledge of oncology.One of the most frequently used scheme, particularly one of the most frequently used scheme in the breast carcinoma first-line treatment is called FAC, begins to use the chemotherapy of being made up of following three kinds of medicines " mixture (cocktail) " to carry out: fluorouracil, amycin (doxorubicin) and cyclophosphamide.This scheme specifically comprises per one weeks of 4 week treatments, and totally 4 to 6 treatment cycle amount to and continue 4 to 6 months: this dosage regimen gave 500mg/m at the 1st day 2Fluorouracil, 50mg/m 2Doxorubicin and 500mg/m 2Cyclophosphamide gave 500mg/m afterwards at the 5th to 8 day 2Fluorouracil.Even this is a scheme selected in the breast carcinoma first-line treatment, and with regard to response percentages wholly or in part, obtain gratifying result, but still needed the effect and/or the therapeutic index of the antitumor drug that further improvement can get at present.
Protein with anti-tumor activity has open in WO 92/10197, WO 96/02567 and WO97/30154: one of these protein (isolating from Hepar Caprae seu ovis extract) are formed by containing 137 amino acid whose aminoacid sequences, it is at Biochim.Biophys.Acta, among 1442 (1998) 49-59 report is arranged, in the document, also disclose the expression of corresponding cDNA in bacillus coli.This protein described in WO 92/10197 and contain described proteinic Hepar Caprae seu ovis perchloric acid extraction thing and at present just use, study especially for the potential drug of the cancer in the multiple source of treatment as being used for multiple treatment, they have shown the cytotoxic activity of significant anticancer disease, this cytotoxic activity is obviously by antibody-mediated, for example at British J.Cancer, 79 (1), 1999,54-58; J.Tumor Marker Oncol.12 (1), 1997,29-37; Virchws Arch (1997), 431:323-328; Int.J.Oncol.10:779-785,1997; Ibid, and 8:543-548 is reported in 1996.
Have been found that at present with amic therapy method in commonly used medicine simultaneously, in advance and the protein that is called UK 114 that gives successively or the extract that contains UK 101 can significantly improve the activity of described medicine, and reduce side effect simultaneously.
According to the present invention, UK 114 and/or UK 101 preferred and above-mentioned FAC therapeutic schemes are used in combination, especially for treatment breast carcinoma.According to doctor's judgement, the FAC scheme should be adjusted according to concrete case certainly, although UK 114/UK 101 can use outside gastrointestinal tract, preferably use through subcutaneous, dosage is 1 to 20mg, is preferably 2 to 10mg, whole chemotherapy cycles the duration on every Mondays or twice.Can and use UK114/UK 101 between twice successive FAC treatment cycle during the FAC treatment.
The advantageous effects of collaborative or any favourable type of UK 114/UK 101 also can with the combination of other cancer therapy drug in observe, described other cancer therapy drug can be separately or the cancer therapy drug of suitable combination, is preferred though be used in combination according to such scheme and fluorouracil, doxorubicin (or other anthracyclines such as idarubicin or epirubicin) and cyclophosphamide.
For at therapeutic use, can use by extracting or UK 114 protein of DNA recombinant technique acquisition or the Hepar Caprae seu ovis perchloric acid extraction thing described in the WO 92/10197, wherein UK 114 protein have description at Biochim.Biophys.Acta among 1442 (1998) 49-59 and the WO 00/63368.
22 patient's restriction groups are carried out preliminary test, and described patient suffers from breast ductal cancer or wellability marrow sample breast carcinoma, and the age was 27 to 76 one full year of life, accepts the FAC scheme and (uses 500mg/m at the 1st day 2Fluorouracil, 50mg/m 2Doxorubicin and 500mg/m 2Cyclophosphamide is afterwards at the 8th day applied once 500mg/m 2Fluorouracil, every one-period all around amounts to 4 months), this preliminary test is verified: with 10mg UK 101 treatments once, amount to 4 months, the quality of can making the life better weekly, reduce the use of analgesic, and can increase by only treating desired treatment and reply with FAC.

Claims (4)

1. the pharmaceutical composition of combining form, said composition contains:
A. the Hepar Caprae seu ovis perchloric acid extraction thing that contains protein UK 114;
B. cyclophosphamide;
C. doxorubicin or other anthracyclines;
D.5-fluorouracil,
Simultaneously, be used for amic therapy method respectively or successively.
2. protein UK 114 or the Hepar Caprae seu ovis perchloric acid extraction thing that contains them are used for making up with the chemotherapy standard scheme purposes of the medicine of Synergistic treatment cancer in preparation.
3. the purposes described in claim 2, wherein said being combined as and 5-fluorouracil, cyclophosphamide and doxorubicin combination.
4. the purposes described in claim 2 or 3 is used for the treatment of breast carcinoma.
CNA2003801024658A 2002-10-30 2003-10-27 Anti-tumor combinations comprising proteins and chemotherapeutics Pending CN1708315A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITMI2002A002307 2002-10-30
IT002307A ITMI20022307A1 (en) 2002-10-30 2002-10-30 ANTI-TUMORAL ASSOCIATIONS INCLUDING PROTEINS AND CHEMOTHERAPIES.

Publications (1)

Publication Number Publication Date
CN1708315A true CN1708315A (en) 2005-12-14

Family

ID=32211391

Family Applications (1)

Application Number Title Priority Date Filing Date
CNA2003801024658A Pending CN1708315A (en) 2002-10-30 2003-10-27 Anti-tumor combinations comprising proteins and chemotherapeutics

Country Status (8)

Country Link
KR (1) KR20050075761A (en)
CN (1) CN1708315A (en)
AU (1) AU2003285304A1 (en)
BR (1) BR0315813A (en)
IT (1) ITMI20022307A1 (en)
MX (1) MXPA05004514A (en)
RU (1) RU2005113167A (en)
WO (1) WO2004039393A1 (en)

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT1244879B (en) * 1990-12-11 1994-09-12 Alberto Bartorelli EXTRACTS FROM ANIMAL TISSUES, USEFUL IN THERAPY AND DIAGNOSTICS.
US5283238A (en) * 1992-04-24 1994-02-01 Immtech International, Inc. Methods of treating cancer using modified C-reactive protein
IT1270618B (en) * 1994-07-14 1997-05-07 Zetesis Spa PROTEIN WITH ANTI-TUMOR ACTIVITY
ITMI991384A1 (en) * 1999-06-22 2000-12-22 Zetesis Spa USE OF UK 114 PROTEIN TO INHIBIT ORGAN TRANSPLANT REJECTION

Also Published As

Publication number Publication date
WO2004039393A1 (en) 2004-05-13
MXPA05004514A (en) 2005-07-26
AU2003285304A1 (en) 2004-05-25
KR20050075761A (en) 2005-07-21
BR0315813A (en) 2005-09-20
RU2005113167A (en) 2005-11-20
ITMI20022307A1 (en) 2004-04-30

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