WO1997028812A2 - Pharmaceutical compositions for biological treatment of infections by enterococcus faecium strains resistant to antibiotics and to vancomycin in particular (vre) - Google Patents

Pharmaceutical compositions for biological treatment of infections by enterococcus faecium strains resistant to antibiotics and to vancomycin in particular (vre) Download PDF

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Publication number
WO1997028812A2
WO1997028812A2 PCT/EP1997/000558 EP9700558W WO9728812A2 WO 1997028812 A2 WO1997028812 A2 WO 1997028812A2 EP 9700558 W EP9700558 W EP 9700558W WO 9728812 A2 WO9728812 A2 WO 9728812A2
Authority
WO
WIPO (PCT)
Prior art keywords
enterococcus faecium
strain
vancomycin
infections
vre
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.)
Ceased
Application number
PCT/EP1997/000558
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English (en)
French (fr)
Other versions
WO1997028812A3 (en
Inventor
Herman Goossens
Giuliano Frigerio
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
GIULIANI SA
Original Assignee
GIULIANI SA
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 GIULIANI SA filed Critical GIULIANI SA
Publication of WO1997028812A2 publication Critical patent/WO1997028812A2/en
Publication of WO1997028812A3 publication Critical patent/WO1997028812A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A61K35/741—Probiotics
    • A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs

Definitions

  • said patent relates to compositions in which bacteria of Enterococcus faecium species are used which belong to SF68 bacterial strain.
  • SF68 bacterial strain is the active principle of the patent medicine BIOFLORIN®, a well-documented biological preparation containing this particular strain of Enterococcus faecium in dry form, widely used for treating acute diarrhoeal enterocolitis forms.
  • Enterococcus faecium formerly classified within the family of Streptococcacee, Streptococcus genus of Lancefield' s D group, has been considered as belonging to Enterococcus genus, and appears as being a gram +, aerobic, facultative anaerobic, non-sporigenous, non-mobile spherical coccus of approximately 1 ⁇ of diameter, generally forming variously long chains of cells.
  • the optimal growth temperature is of 36-37°C, and the optimal growth pH value is 7.
  • the particularly suitable culture media for an optimal growth are MRS broth (Difco) and horse blood agar.
  • the growth can be estimated from a uniform turbidity in liquid media and the formation of small round, slightly convex, smooth colonies on solid media. On colonies growing in blood agar a slight ⁇ -hemolysis can be observed.
  • SF68 strain was originally isolated from human organisms and was also used in food industry, in particular for cheese fermentation.
  • Giuliani Company developed their preparation during 1978-1980, through a very large amount of toxicological, microbiological and clinical studies; nearly all of the latter were carried out as controlled double-blind vs. placebo or vs. active control studies.
  • the survey by Loizeau E. (published on "Revue Medicale de la Canal Ro ande” 114; 651, 1994) summarizes the biological and clinical properties of the preparation.
  • VRE vancomycin-resistant enterococci because they are very often implied in nosocomial emergencies (nosocomial or hospital infections) with a high potential of morbility and mortality, as observed from important epidemiological studies performed in the U.S.A. and Europe.
  • Campylobacter whereas rather low resulted to be the activity against Helicobacter pilori.
  • Enterococcus faecium shows the capability of regularly inhibiting, by means of the production of biologically active substances, with a reproducibility of 100%, the growth of other vancomycin-resistant (VRE) strains of Enterococcus faecium of Van-A and Van-B types, against which it was tested.
  • VRE vancomycin-resistant
  • the microbiological studies were carried out according to the proper microbiologic methods.
  • the cultivation of Enterococcus faecium strains was carried out in Mueller-Hinton II broth, overnight at 37°C under a 5% C0 2 atmosphere.
  • the culture of bacteriocins producer SF68 strain was centrifuged at 13,000 rpm during 5 minutes in order to remove the cells, and the cell-free supernatant was then incubated at 80°C during 1 minute (most bacteriocins survive this treatment which allows the operators to prevent producer cells from further growing) .
  • the observations at time points "0", "4", "8" and "30" hours were carried out on microtitration plates, to which the following media had been added:
  • the strains of Enterococcus faecium showing charactetistics of resistance to vancomycin (either of Van-A or Van-B type) against which the antibacterial activity of Enterococcus faecium SF68 strain was tested had been isolated in human clinic from different sources (comprising faeces, blood, infected wounds) on the occasion of a multicentric epidemiological study carried out in Belgium.
  • the "Van" genotype was determined by using a "PCR” based on the technique described by Dutka-Malen et al. ("Detection of glycopeptide resistance genotypes and identification to the species level of clinically relevant enterococci” - J. Clin. Microbiol. 33: 24- 27 - 1995) .
  • Other strains of Enterococcus faecium came from collections (LGM — see following table) .
  • Van-B type 1 1 100 %
  • VRE's vancomycin-resistant enterococci
  • the subjects were treated with a pharmaceutical preparation in the form of capsules containing at least 75 x 10 6 CFU of Enterococcus faecium SF68® strain per each capsule (available under the trade name BIOFLORIN®) , administered at the dosage of 2 capsules three times per day during 5 days.
  • the control coprocultures were performed at time "0", then after the 5 treatment days and were then repeated after 1, 3, 5, and 25 days from treatment end.
  • the strains of Enterococcus faecium must display vital characteristics and the CFU ("colony forming unit") amount to be administered every day must range from 10,000,000 units up to more than 10,000,000,000 units; the width of the dosage range is justified by the matter of fact that the essential aspect for the biological effect is that conditions exist in the body which allow the bacteria to multiply — which, per se, typically multiply very rapidly (doubling in number every 19 minutes) .
  • CFU colony forming unit
  • compositions the following examples may be cited: 1) Hard gelatine capsules Per each capsule: - Enterococcus faecium SF68 strain >75,000,000
  • the pellets can be made gastroresistant by coating them with a shell of methacrylic acid polymers.

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  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
PCT/EP1997/000558 1996-02-08 1997-02-05 Pharmaceutical compositions for biological treatment of infections by enterococcus faecium strains resistant to antibiotics and to vancomycin in particular (vre) Ceased WO1997028812A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT96MI000239A IT1282586B1 (it) 1996-02-08 1996-02-08 Composizioni farmaceutiche per il trattamento biologico delle infezioni dovute a ceppi di enterococcus faecium resistenti agli
ITMI96A000239 1996-02-08

Publications (2)

Publication Number Publication Date
WO1997028812A2 true WO1997028812A2 (en) 1997-08-14
WO1997028812A3 WO1997028812A3 (en) 1997-10-02

Family

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PCT/EP1997/000558 Ceased WO1997028812A2 (en) 1996-02-08 1997-02-05 Pharmaceutical compositions for biological treatment of infections by enterococcus faecium strains resistant to antibiotics and to vancomycin in particular (vre)

Country Status (2)

Country Link
IT (1) IT1282586B1 (cs)
WO (1) WO1997028812A2 (cs)

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6303312B1 (en) 1996-07-31 2001-10-16 California Institute Of Technology Complex formation between dsDNA and oligomer of cyclic heterocycles
US6392012B1 (en) 1998-12-23 2002-05-21 Advanced Medicine, Inc. Glycopeptide derivatives and pharmaceutical compositions containing the same
US6472537B1 (en) 1996-02-26 2002-10-29 California Institute Of Technology Polyamides for binding in the minor groove of double stranded DNA
US6518242B1 (en) 1998-02-20 2003-02-11 Theravance, Inc. Derivatives of glycopeptide antibacterial agents
EP1477555A3 (en) * 2003-05-15 2004-12-15 Yasuo Kawai Method for culturing bacterial cells belonging to the enterococcus genus and method of producing killed bacterial cells belonging to the enterococcus genus
WO2005018654A1 (en) * 2003-08-26 2005-03-03 Obschestvo S Ogranichennoi Otvetstvennostyu Alef-Farma Use of enrerococcus faecium strains for curing hepatic insufficiency and for regenerating and intensifying metabolism in a liver
WO2007035938A2 (en) 2005-09-22 2007-03-29 Medivas, Llc BIS-(α-AMINO)-DIOL-DIESTER-CONTAINING POLY(ESTER AMIDE) AND POLY(ESTER URETHANE) COMPOSITIONS AND METHODS OF USE
WO2007038246A2 (en) 2005-09-22 2007-04-05 Medivas, Llc Solid polymer delivery compositions and methods for use thereof
EP1852122A1 (en) * 2006-05-02 2007-11-07 Truffini & Regge' Farmaceutici SRL Dental and gingival health compositions containing reactivatable, dehydrated, eubiotic micro-organisms
WO2009081958A1 (ja) 2007-12-26 2009-07-02 Shionogi & Co., Ltd. グリコペプチド抗生物質配糖化誘導体
WO2009123713A1 (en) 2008-04-01 2009-10-08 Cornell University Organo-soluble chitosan salts and chitosan-derived biomaterials prepared thereof
EP2164333A4 (en) * 2007-05-24 2010-07-28 Nestec Sa COMPOSITIONS AND METHODS USEFUL FOR MODULATING IMMUNITY, IMPROVING THE EFFICACY OF A VACCINE, REDUCING THE MORBIDITY ASSOCIATED WITH CHRONIC INFECTIONS BY FHV-1, AND PREVENTING OR TREATING CONJUNCTIVITIS
EP2314599A1 (en) 2004-11-29 2011-04-27 National University Corporation Nagoya University Glycopeptide antibiotic monomer derivatives
IT202200013138A1 (it) * 2022-06-22 2023-12-22 Cerbios Pharma Sa Probiotico per l’uso nel trattamento di alterazioni infiammatorie della mucosa intestinale, in particolare obesità

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT1112479B (it) * 1979-04-02 1986-01-13 Giuliani Sa Composizione farmaceutica particolarmente atta alla terapia di enteriti e di affezioni diarroiche generiche
EP0405569A1 (de) * 1989-06-30 1991-01-02 Cernitin S.A. Produkt mit antimikrobieller Wirksamkeit, Verfahren zu dessen Isolierung aus dem Kulturmedium von Streptokokkus faecium und pharmazeutisches Präparat, enthaltend dieses Produkt mit antimikrobieller Wirksamkeit

Cited By (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6472537B1 (en) 1996-02-26 2002-10-29 California Institute Of Technology Polyamides for binding in the minor groove of double stranded DNA
US6303312B1 (en) 1996-07-31 2001-10-16 California Institute Of Technology Complex formation between dsDNA and oligomer of cyclic heterocycles
US6518242B1 (en) 1998-02-20 2003-02-11 Theravance, Inc. Derivatives of glycopeptide antibacterial agents
US7351791B2 (en) 1998-12-23 2008-04-01 Theravance, Inc. Intermediate for preparing glycopeptide derivatives
US6392012B1 (en) 1998-12-23 2002-05-21 Advanced Medicine, Inc. Glycopeptide derivatives and pharmaceutical compositions containing the same
US6444786B1 (en) 1998-12-23 2002-09-03 Advanced Medicine, Inc. Glycopeptide derivatives and pharmaceutical compositions containing the same
US6455669B1 (en) 1998-12-23 2002-09-24 Theravance, Inc. Glycopeptide derivatives and pharmaceutical compositions containing the same
US6962970B2 (en) 1998-12-23 2005-11-08 Theravance, Inc. Glycopeptide derivatives and pharmaceutical compositions containing the same
US7101964B2 (en) 1998-12-23 2006-09-05 Theravance, Inc. Intermediate for preparing glycopeptide derivatives
US7723470B2 (en) 1998-12-23 2010-05-25 Theravance, Inc. Glycopeptide derivatives and pharmaceutical compositions containing the same
EP1477555A3 (en) * 2003-05-15 2004-12-15 Yasuo Kawai Method for culturing bacterial cells belonging to the enterococcus genus and method of producing killed bacterial cells belonging to the enterococcus genus
WO2005018654A1 (en) * 2003-08-26 2005-03-03 Obschestvo S Ogranichennoi Otvetstvennostyu Alef-Farma Use of enrerococcus faecium strains for curing hepatic insufficiency and for regenerating and intensifying metabolism in a liver
EP2314599A1 (en) 2004-11-29 2011-04-27 National University Corporation Nagoya University Glycopeptide antibiotic monomer derivatives
US8778874B2 (en) 2004-11-29 2014-07-15 National University Corporation Nagoya University Glycopeptide antibiotic monomer derivatives
WO2007038246A2 (en) 2005-09-22 2007-04-05 Medivas, Llc Solid polymer delivery compositions and methods for use thereof
WO2007035938A2 (en) 2005-09-22 2007-03-29 Medivas, Llc BIS-(α-AMINO)-DIOL-DIESTER-CONTAINING POLY(ESTER AMIDE) AND POLY(ESTER URETHANE) COMPOSITIONS AND METHODS OF USE
EP1852122A1 (en) * 2006-05-02 2007-11-07 Truffini & Regge' Farmaceutici SRL Dental and gingival health compositions containing reactivatable, dehydrated, eubiotic micro-organisms
EP2164333A4 (en) * 2007-05-24 2010-07-28 Nestec Sa COMPOSITIONS AND METHODS USEFUL FOR MODULATING IMMUNITY, IMPROVING THE EFFICACY OF A VACCINE, REDUCING THE MORBIDITY ASSOCIATED WITH CHRONIC INFECTIONS BY FHV-1, AND PREVENTING OR TREATING CONJUNCTIVITIS
WO2009081958A1 (ja) 2007-12-26 2009-07-02 Shionogi & Co., Ltd. グリコペプチド抗生物質配糖化誘導体
US8481696B2 (en) 2007-12-26 2013-07-09 Shionogi & Co., Ltd. Glycosylated glycopeptide antibiotic derivatives
WO2009123713A1 (en) 2008-04-01 2009-10-08 Cornell University Organo-soluble chitosan salts and chitosan-derived biomaterials prepared thereof
IT202200013138A1 (it) * 2022-06-22 2023-12-22 Cerbios Pharma Sa Probiotico per l’uso nel trattamento di alterazioni infiammatorie della mucosa intestinale, in particolare obesità
WO2023247472A1 (en) * 2022-06-22 2023-12-28 Cerbios-Pharma Sa Probiotic for use in the treatment of inflammatory alterations of the intestinal mucosa, particularly obesity
JP2025522641A (ja) * 2022-06-22 2025-07-16 セルビオス － ファルマ・エス・アー 腸粘膜の炎症性変化、特に肥満の治療に使用するプロバイオティクス

Also Published As

Publication number Publication date
ITMI960239A1 (it) 1997-08-08
ITMI960239A0 (cs) 1996-02-08
IT1282586B1 (it) 1998-03-31
WO1997028812A3 (en) 1997-10-02

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