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.

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

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Publications (1)

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• 2000
  • 2000-10-13 WO PCT/US2000/028361 patent/WO2001054727A1/en not_active Application Discontinuation
  • 2000-10-13 MX MXPA02003742A patent/MXPA02003742A/es unknown
  • 2000-10-13 AU AU12018/01A patent/AU1201801A/en not_active Abandoned
  • 2000-10-13 CA CA002383626A patent/CA2383626A1/en not_active Abandoned
  • 2000-10-13 EP EP00973515A patent/EP1220688A1/de not_active Withdrawn

Non-Patent Citations (1)

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