EP1220688A1 - Traitement de tumeurs cutanees, verrues et infections virales utilisant du p. acnes tue par la chaleur - Google Patents

Traitement de tumeurs cutanees, verrues et infections virales utilisant du p. acnes tue par la chaleur

Info

Publication number
EP1220688A1
EP1220688A1 EP00973515A EP00973515A EP1220688A1 EP 1220688 A1 EP1220688 A1 EP 1220688A1 EP 00973515 A EP00973515 A EP 00973515A EP 00973515 A EP00973515 A EP 00973515A EP 1220688 A1 EP1220688 A1 EP 1220688A1
Authority
EP
European Patent Office
Prior art keywords
acnes
product
warts
propionibacterium
administered
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.)
Withdrawn
Application number
EP00973515A
Other languages
German (de)
English (en)
Inventor
Kent R. Van Kampen
Bobby G. Edwards
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.)
Van Kampen Group Inc
Original Assignee
Van Kampen Group Inc
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 Van Kampen Group Inc filed Critical Van Kampen Group Inc
Publication of EP1220688A1 publication Critical patent/EP1220688A1/fr
Withdrawn legal-status Critical Current

Links

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
    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof

Definitions

  • the present invention relates to methods to treat viral infections, dermal tumors, and warts in humans using heat-killed bacterial compositions. Specifically, it relates to the subcutaneous or intralesional administration of heat-killed Propionibacterium acnes (P. acnes), to treat dermal tumors and warts, and to the oral administration of heat-killed P. acnes to treat virus induced infections of the respiratory tract in humans.
  • P. acnes heat-killed Propionibacterium acnes
  • Bacteria and their derivatives were among the first substances to be recognized as immunostimulators and are used as adjuvants in vaccines to boost the humoral immune response (e.g., complete Freund's adjuvant). Bacteria have also been used as non-specific enhancers of the immune system to increase resistance and rejection of cancers, parasites, and infectious organisms.
  • Acnes is known to act by stimulating macrophages and neutrophils, initiating endogenous production of lymphokines (including IL-2 and various interferons), and enhancing killer cell activity.
  • lymphokines including IL-2 and various interferons
  • the intranasal inoculation of mice with P. acnes has been shown to activate pulmonary macrophages (Jackson RA, et al., JLeukoc. Biol, 40(5):575- 87, 1986).
  • P. acnes acts upon monocytes and lymphocytes and improves the functional interaction between these cells (M.T. Scott, Cell Immunol., 17:141, 1975).
  • P. acnes also functions as an immune adjuvant to weakly antigenic substances.
  • P. acnes has, in general been limited to treatment of neoplastic diseases and pleural effusions with some limited success. Additionally, P. acnes has been administered orally in the rations of food production animals to promote better health through cell-mediated immunity and weight gain (U.S. Patent Application Serial No. 08/912,026). It has been used experimentally in people to treat various cancers, plural effusion and chronic obstructive pulmonary disease. It has been used experimentally as an adjuvant with vaccines.
  • a veterinary preparation of P. acnes was used as an injectable therapeutic agent against plantar warts caused by the human papilloma virus.
  • significant pain upon injection was observed caused due to the alcohol content of the preparation.
  • a preparation of P. acnes is needed that causes the regression of warts and dermal tumors in humans, but which may be administered without undue pain or harm to the patient. Additionally, this preparation must be administered via a route that allows regression of the warts while minimizing pain to the patient .
  • P. acnes has been used to treat respiratory diseases in horses and cattle, the oral administration of P. acnes with efficacy in humans has not been previously demonstrated. There is a need for a P. acnes preparation that can be safely administered to humans for the treatment of viral infections of the respiratory tract.
  • This invention also relates to the preparation of an alcohol-free, terminally sterilized saline- suspended P. acnes product that causes the regression of dermal tumors, and plantar warts in humans. Terminal sterilization may be conducted through the process of autoclaving. In another embodiment of the product, an anesthetic such as lidocaine is added to the P. acnes product.
  • the invention also relates to a novel intralesional administration of the P. acnes product into plantar warts, or other warts caused by the human papilloma virus causing regression of such warts, and the subcutaneous administration of the P. acnes product resulting in a systemic regression of warts.
  • This invention relates to the preparation, administration, and use of an inactivated bacterial product to induce regression of virally induced dermal tumors and warts, and to effectively treat virally induced infections of the respiratory tract.
  • the warts may be plantar, genital, or surface warts anywhere on the skin or mucosal surface of the body, or those caused by the human papilloma virus.
  • the bacteria used for practicing the invention may be selected from the group consisting of Propionibacterium acnes, Propionibacterium avidum, Propionibacterium lymphophilum, Propionibacterium granulosum, Cornynebacterium parvum or Arachnia propionica.
  • the bacteria used for practicing the invention are selected from the Propionibacterium family.
  • the bacteria used for practicing the invention is Propionibacterium acnes (P. acnes).
  • P. acnes will be the bacterium referred to throughout the description, although any of the bacterial species claimed can be substituted.
  • P. acnes is known to be commercially available in forms such as an injectable solution (e.g., ImmunoRegulin ® or EqStim ® by Neogen Corp. (Lansing, MI)), but it may also be isolated and cultured by known, standard bacterial procedures or obtained from national culture collections.
  • the bacteria used were obtained from ImmunoVet Corp. (Tampa, FL) who produced them under U.S.D.A. Product Code 9350.00.
  • the bacteria may also be obtained from Neogen Corp. (Lansing, MI).
  • the bacteria may be provided wet or dry.
  • a dry form may be prepared by standard drying methods known to a person skilled in the art. such as freeze-drying or evaporation.
  • the P. acnes may be lyophilized at any step in the preparation process depending on whether the final pharmaceutical formulation is to be stored as a liquid with stabilizing fillers, or as a lyophilized solid.
  • the first patient was a 60-year old Caucasian male weighing 190 pounds.
  • the patient was treated with the suspension on two separate occasions.
  • the patient had symptoms of a sore throat and ear inflammation.
  • the treatment was administered orally.
  • the material was held at the back of the mouth for about 1 minute before swallowing.
  • the patient felt somewhat flushed, a symptom that could be related to the infection or to immunostimulation.
  • the onset of the sore throat and the ear infection diminished.
  • the patient was healthy with no remaining symptoms of the sore throat and ear infection.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention concerne des suspensions salines de Propionibacterum acnes, Propionibacterium avidum, Propionibacterium lymphophylum, Propionibacterium granulosum, Cornyebacterium parvum, et Arachnia propionica stérilisées et tuées à la chaleur efficaces dans le traitement d'infections virales des voies respiratoires de l'homme et dans la promotion de la régression des tumeurs cutanées, verrues chez l'homme. L'activité thérapeutique de cette suspension saline de Propionibacterium acnes (P. acnes) a été démontrée par un modèle d'animal de laboratoire. Le produit P. acnes est administré par voie orale à des fins de prévention ou de traitement des infections virales des voies respiratoires chez l'homme. La préparation P. acnes est administrée par voie intralésionnelle dans les tumeurs cutanées et les verrues, notamment les verrues plantaires ou d'autres verrues provoquées par le papillomavirus afin de faire régresser les tumeurs cutanées et les verrues. L'administration par voie sous-cutanée du P. acnes entraîne une réaction systémique qui se traduit par la disparition totale des verrues sur le long terme. Des anesthésiques comme Lidocaïne peuvent être ajoutés au produit à base de P. acnes afin de prévenir la douleur lors de l'injection de cette préparation d'immunomodulation tout en maintenant l'activité thérapeutique du produit de P. acnes. Des dosages ont été établis pour l'administration par voie orale dudit produit de P. acnes afin de traiter les infections virales et pour l'administration par voie sous-cutanée et intralésionnelle du même produit afin de traiter les tumeurs cutanées et les verrues.
EP00973515A 1999-10-15 2000-10-13 Traitement de tumeurs cutanees, verrues et infections virales utilisant du p. acnes tue par la chaleur Withdrawn EP1220688A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US15956799P 1999-10-15 1999-10-15
US159567P 1999-10-15
PCT/US2000/028361 WO2001054727A1 (fr) 1999-10-15 2000-10-13 Traitement de tumeurs cutanees, verrues et infections virales utilisant du p. acnes tue par la chaleur

Publications (1)

Publication Number Publication Date
EP1220688A1 true EP1220688A1 (fr) 2002-07-10

Family

ID=22573102

Family Applications (1)

Application Number Title Priority Date Filing Date
EP00973515A Withdrawn EP1220688A1 (fr) 1999-10-15 2000-10-13 Traitement de tumeurs cutanees, verrues et infections virales utilisant du p. acnes tue par la chaleur

Country Status (5)

Country Link
EP (1) EP1220688A1 (fr)
AU (1) AU1201801A (fr)
CA (1) CA2383626A1 (fr)
MX (1) MXPA02003742A (fr)
WO (1) WO2001054727A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103547276A (zh) * 2010-11-11 2014-01-29 雀巢产品技术援助有限公司 保护免受上呼吸道感染的非复制性益生菌微生物

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8124630B2 (en) 1999-01-13 2012-02-28 Bayer Healthcare Llc ω-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors
EP1158985B1 (fr) 1999-01-13 2011-12-28 Bayer HealthCare LLC DIPHENYLE UREES A SUBSTITUTION OMEGA-CARBOXY ARYLE EN TANT QU'INHIBITEURS DE LA KINASE p38
JP4636486B2 (ja) 2002-02-11 2011-02-23 バイエル、ファーマシューテイカルズ、コーポレイション 脈管形成阻害活性を有するアリール尿素
DK1636585T3 (da) 2003-05-20 2008-05-26 Bayer Pharmaceuticals Corp Diarylurinstoffer med kinasehæmmende aktivitet
BRPI0412219B8 (pt) 2003-07-23 2021-07-27 Bayer Healthcare Llc compostos ômega-carboxi aril difenil uréia fluoro substituídos e composições farmacêuticas compreendendo os referidos compostos
AU2005326226B2 (en) 2005-01-31 2010-11-11 Eci, Inc. Immunopotentiating agent
CN117511758A (zh) * 2022-08-04 2024-02-06 复旦大学附属华山医院 痤疮丙酸杆菌、其应用、组合物和药物
CN115317520B (zh) * 2022-09-06 2024-04-05 浙江大学 一种锌铝类水滑石-痤疮丙酸杆菌细菌杂化材料及其制备方法、应用

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4479935A (en) * 1980-04-22 1984-10-30 Institut Pasteur Fractions extracted from aerobic bacteria, endowed with antitumoral, antibacterial and interferon inducing properties, and process for their preparation
JPS59161320A (ja) * 1983-03-04 1984-09-12 Maruyama Chisato リポ多糖体およびその製造法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO0154727A1 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103547276A (zh) * 2010-11-11 2014-01-29 雀巢产品技术援助有限公司 保护免受上呼吸道感染的非复制性益生菌微生物

Also Published As

Publication number Publication date
MXPA02003742A (es) 2003-10-14
CA2383626A1 (fr) 2001-08-02
WO2001054727A1 (fr) 2001-08-02
AU1201801A (en) 2001-08-07

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