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WO2007046966A2 - Methods for the treatment of influenza - Google Patents

Methods for the treatment of influenza Download PDF

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Publication number
WO2007046966A2
WO2007046966A2 PCT/US2006/034640 US2006034640W WO2007046966A2 WO 2007046966 A2 WO2007046966 A2 WO 2007046966A2 US 2006034640 W US2006034640 W US 2006034640W WO 2007046966 A2 WO2007046966 A2 WO 2007046966A2
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WO
WIPO (PCT)
Prior art keywords
influenza
thimerosal
influenza virus
virus
composition
Prior art date
Application number
PCT/US2006/034640
Other languages
French (fr)
Other versions
WO2007046966A3 (en
Inventor
John Mcmichael
Original Assignee
Milkhaus Laboratory, 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 Milkhaus Laboratory, Inc filed Critical Milkhaus Laboratory, Inc
Publication of WO2007046966A2 publication Critical patent/WO2007046966A2/en
Publication of WO2007046966A3 publication Critical patent/WO2007046966A3/en

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Classifications

    • 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
    • A61K31/28—Compounds containing heavy metals
    • A61K31/305—Mercury compounds
    • A61K31/31—Mercury compounds containing nitrogen

Definitions

  • the present invention relates to materials and methods for the treatment of influenza virus infections.
  • influenza-type viruses which affect human beings: Influenza A, B and C.
  • Influenza A including H5N1
  • viruses have been isolated from many animal species in addition to humans, while the influenza B and C viruses infect mainly humans.
  • the influenza viruses are enveloped viruses containing negative single-stranded RNA's which are segmented and encapsulated.
  • the influenza virus envelope is characterized by the presence of two surface glycoproteins: hemagglutinin and neuraminidase.
  • the influenza A and B virions are pleomorphic and are usually 80-120 nm in diameter.
  • the influenza C virion has many distinctive properties and is thus distinguished from the closely related A and B virions. Infection with influenza A or B often can cause a highly contagious, acute respiratory illness.
  • Influenza viruses have a major impact on morbidity leading to increases in hospitalization and in visits to health care providers. High rates of hospitalization are observed for patients over 65 years of age and also for children less than 5 years of age. Influenza virus is also unique among respiratory viruses in being a cause of excess mortality. Furthermore, the spread of influenza virus through a population can result in epidemics which have considerable economic impact.
  • influenza vaccine Use of the available influenza vaccine is an effective way to lower the mortality in a population, however due to the ever- changing nature of the virus, the development of a vaccine with the appropriate composition to protect against the currently circulating virus strains is complex and expensive. Moreover, patient compliance in receiving the vaccine is generally very low. Thus, large numbers of patients at risk of serious complications from influenza virus go unprotected. Accordingly, there is a world-wide need for improved therapeutic agents for the treatment of influenza virus infections.
  • Influenza virus vaccines have been used to treat other virus infections, such as herpes virus infections, as reported in Lieberman, Clinical Ecology, 7(3):51-54 (1990) and McMichael U.S. Patent Nos. 4,521,405 and 4,880,626, all of which are incorporated herein by reference.
  • Influenza vaccines induce a modified immune response such that symptoms were alleviated as a consequence of neutralizing the body's response to the infectious agent by stimulating suppressor T-cells.
  • the T-cells in turn down-regulated effector cells and thus interrupted the allergic-type reaction induced by simultaneous lysis of many cells infected with the influenza virus.
  • the present invention provides methods for treating subjects suffering from influenza virus infections, comprising the step of administering an effective amount of a composition comprising thimerosal free of association with influenza virus in a pharmaceutically acceptable carrier or excipient to a subject suffering from influenza virus infection.
  • the methods of the invention act to treat the influenza virus infections as well as the symptoms of those infections including, for example, fever; headache; muscle aches; respiratory symptoms, such as cough, sore throat, runny or stuffy nose; and fatigue.
  • the present invention provides the composition comprising thimerosal free of association with influenza virus to be administered in a dosage of from 0.05 ⁇ g to 500 ⁇ g, or more preferably 0.05 ⁇ g to 50 ⁇ g, or most preferably 0.2 ⁇ g. Also provided is the administration of the thimerosal composition in a single dose of 0.05 cc in a pharmaceutically acceptable carrier or excipient.
  • the methods of the invention may be used to treat Influenza A viruses generally as well as Influenza A H5N1 strain viruses sometimes referred to as "avian influenza.”
  • the present invention also provides methods for administration of the thimerosal composition comprising sublingual or subcutaneous administration.
  • Thimerosal can be used for treating subjects suffering from influenza virus infections by administering an effective amount of a composition comprising thimerosal, free of association with influenza virus.
  • the thimerosal is formulated in compositions that include at least one pharmaceutically acceptable diluent, adjuvant, or carrier substance, using any available pharmaceutical chemistry techniques. Generally, this entails preparing compositions that are essentially free of pyrogens, as well as other impurities that could be harmful to humans or animals.
  • pharmaceutically acceptable carrier or excipient includes any and all solvents, dispersion media, coatings, antibacterial and antifungal agents, isotonic and absorption delaying agents and the like.
  • the use of such media and agents for pharmaceutical active substances is well known in the art. Except insofar as any conventional media or agent is incompatible with the active ingredient, its use in the therapeutic compositions is contemplated. Supplementary active ingredients also can be incorporated into the compositions.
  • Administration of thimerosal used in the pharmaceutical composition to practice the method of the present invention can be carried out in a variety of conventional ways, such as oral ingestion, sublingual application, subcutaneous, intraperitoneal, parenteral or intravenous injection. Sublingual administration to the subject is preferred.
  • the treatment may consist of a single dose or a plurality of doses over a period of time.
  • the compounds can be formulated readily by combining thimerosal with pharmaceutically acceptable carriers well known in the art.
  • Such carriers enable the compounds of the invention to be formulated as tablets, pills, dragees, capsules, liquids, gels, syrups, slurries, suspensions and the like, for oral ingestion by a subject to be treated.
  • Pharmaceutical preparations for oral use can be obtained using a solid excipient, optionally grinding a resulting mixture, and processing the mixture of granules, after adding suitable auxiliaries, if desired, to obtain tablets or dragee cores.
  • Suitable excipients are, in particular, fillers such as sugars, including lactose, sucrose, mannitol, or sorbitol; cellulose preparations such as, for example, maize starch, wheat starch, rice starch, potato starch, gelatin, gum tragacanth, methyl cellulose, hydroxypropylmethyl cellulose, sodium carboxymethylcellulose, and/or polyvinylpyrrolidone (PVP).
  • disintegrating agents may be added, such as the cross linked polyvinyl pyrrolidone, agar, or alginic acid or a salt thereof such as sodium alginate.
  • Dragee cores are provided with suitable coatings.
  • concentrated sugar solutions may be used, which may optionally contain gum arabic, talc, polyvinyl pyrrolidone, carbopol gel, polyethylene glycol, and/or titanium dioxide, lacquer solutions, and suitable organic solvents or solvent mixtures.
  • compositions which can be used orally include push fit capsules made of gelatin, as well as soft, sealed capsules made of gelatin and a plasticizer, such as glycerol or sorbitol.
  • the push fit capsules can contain the thimerosal in a mixture with filler such as lactose, binders such as starches, and/or lubricants such as talc or magnesium stearate and, optionally, stabilizers, hi soft capsules, the active compounds may be dissolved or suspended in suitable liquids, such as fatty oils, liquid paraffin, or liquid polyethylene glycols. Li addition, stabilizers may be added. All formulations for oral administration should be in dosages suitable for such administration.
  • compositions for parenteral administration include aqueous solutions of thimerosal.
  • Aqueous injection suspensions may contain substances which increase the viscosity of the suspension, such as sodium carboxymethyl cellulose, sorbitol, or dextran.
  • the suspension may also contain suitable stabilizers or agents which increase the solubility of the compounds to allow for the preparation of highly concentrated solutions.
  • the thimerosal may be in powder form for constitution with a suitable vehicle, e.g., sterile pyrogen free water, before use.
  • compositions also may comprise suitable solid or gel phase carriers or excipients.
  • suitable solid or gel phase carriers or excipients include but are not limited to calcium carbonate, calcium phosphate, various sugars, starches, cellulose derivatives, gelatin, and polymers such as polyethylene glycols.
  • a pharmaceutical dosage unit of the present invention for the delivery of thimerosal comprises a liquid or solid carrier and an effective amount of thimerosal.
  • One suitable carrier for sublingual administration comprises a phenylated saline solution.
  • Effective amounts of thimerosal range from about 0.05 ⁇ g to 500 ⁇ g thimerosal with about 0.1 ⁇ g to about 50 ⁇ g thimerosal being preferred and about 0.2 ⁇ g thimerosal being particularly preferred.
  • the subject to be treated may be a chordate including birds and poultry; a mammal, including pigs and humans or other animals.
  • subjects include for example, farm animals including cows, sheep, pigs, horses and goats, companion animals such as dogs and cats, exotic and/or zoo animals, laboratory animals including mice rats, rabbits, guinea pigs and hamsters; and poultry such as chickens, turkey ducks and geese.
  • a 67 year old female presented with the symptoms of classic influenza which had appeared two days previously.
  • the subject was treated by a regimen of sublingual administration of a composition comprising 0.2 micrograms of thimerosal in 1 drop (0.05 ml) of saline.
  • the composition was administered at a rate of one drop every 15 minutes for an hour followed by one drop per hour until bedtime.
  • On the second day of treatment the subject was treated with one drop per hour, as needed.
  • the subject's fever normalized by the end of the first day and the aches associated with influenza were reported to have improved by the second day.
  • the patient reported that she was "back to normal.”

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

Abstract

Methods for treating subjects suffering from influenza virus infections are provided which include the step of administering an effective amount of a composition comprising thimerosal free of association with influenza virus to a subject suffering from an influenza virus infection.

Description

METHODS FOR THE TREATMENT OF INFLUENZA
Field of the Invention
[0001] The present invention relates to materials and methods for the treatment of influenza virus infections.
Background Of The Invention
[0002] There are three known influenza-type viruses which affect human beings: Influenza A, B and C. Influenza A, including H5N1, viruses have been isolated from many animal species in addition to humans, while the influenza B and C viruses infect mainly humans. The influenza viruses are enveloped viruses containing negative single-stranded RNA's which are segmented and encapsulated. The influenza virus envelope is characterized by the presence of two surface glycoproteins: hemagglutinin and neuraminidase. The influenza A and B virions are pleomorphic and are usually 80-120 nm in diameter. The influenza C virion has many distinctive properties and is thus distinguished from the closely related A and B virions. Infection with influenza A or B often can cause a highly contagious, acute respiratory illness.
[0003] Influenza viruses have a major impact on morbidity leading to increases in hospitalization and in visits to health care providers. High rates of hospitalization are observed for patients over 65 years of age and also for children less than 5 years of age. Influenza virus is also unique among respiratory viruses in being a cause of excess mortality. Furthermore, the spread of influenza virus through a population can result in epidemics which have considerable economic impact.
[0004] There are relatively few known compounds that have significant anti- viral activity against influenza viruses. Two of these, amantadine and rimantadine are approved in the United States for the treatment of influenza virus disease. Both compounds are most effective when used prophylactically and influenza viruses develop resistance to both compounds rapidly. See U.S. Patent Nos. 3,152,180 and 3,352,912. Other compounds reported to have activity against influenza viruses are disclosed in U.S. Patent Nos. 3,483,254, 3,496,228, 3,538,160, 3,534,084 and 3,592,934. [0005] The most effective way to deal with the influenza virus for the population at risk of severe complications is by prevention. Use of the available influenza vaccine is an effective way to lower the mortality in a population, however due to the ever- changing nature of the virus, the development of a vaccine with the appropriate composition to protect against the currently circulating virus strains is complex and expensive. Moreover, patient compliance in receiving the vaccine is generally very low. Thus, large numbers of patients at risk of serious complications from influenza virus go unprotected. Accordingly, there is a world-wide need for improved therapeutic agents for the treatment of influenza virus infections.
[0006] Influenza virus vaccines, and their components, have been used to treat other virus infections, such as herpes virus infections, as reported in Lieberman, Clinical Ecology, 7(3):51-54 (1990) and McMichael U.S. Patent Nos. 4,521,405 and 4,880,626, all of which are incorporated herein by reference. Influenza vaccines induce a modified immune response such that symptoms were alleviated as a consequence of neutralizing the body's response to the infectious agent by stimulating suppressor T-cells. The T-cells in turn down-regulated effector cells and thus interrupted the allergic-type reaction induced by simultaneous lysis of many cells infected with the influenza virus. However, the results reported by McMichael and Lieberman attributed to the anti-herpes virus effects of influenza virus vaccines are due to the presence of thimerosal, a preservative present in commercially available influenza virus vaccines, and not to a portion of the killed influenza virus, such as a surface antigen. Further, it has been discovered that the anti-herpes virus activity of influenza virus vaccines is attributable to the presence of thimerosal in the tested compositions and that herpes virus infections can be treated with thimerosal uncombined with or in the absence of influenza virus vaccine. Related to this is the disclosure of Manfuso, U.S. Patent No. 4,803,991 which teaches the treatment of herpes virus infections by the topical administration of thimerosal, but does not teach or suggest the administration of thimerosal systemically.
[0007] In vitro assays with purified thimerosal demonstrate activity against herpes viruses (U.S. Patent Nos. 4,803,991; 5,753,624; and 6,174,916). Of interest is the observation that when thimerosal is mixed in a test tube with herpes virus and is subsequently introduced into susceptible cells, viral propagation is not inhibited. This suggests that the anti-herpes viral activity of thimerosal is not by direct action on the virus. Further study shows that thiosalicylic acid and dithiodibenzoic acid, which are the breakdown products of thimerosal, do not provide antiviral activity in vivo although dithiodibenzoic acid indicated anti-herpes virus activity in vitro.
[0008] Despite the usefulness of influenza vaccines in preventing infection there remains a need for therapies which can be used when prevention by vaccination does not exist or is incomplete or ineffective.
Summary of the Invention
[0009] The present invention provides methods for treating subjects suffering from influenza virus infections, comprising the step of administering an effective amount of a composition comprising thimerosal free of association with influenza virus in a pharmaceutically acceptable carrier or excipient to a subject suffering from influenza virus infection. The methods of the invention act to treat the influenza virus infections as well as the symptoms of those infections including, for example, fever; headache; muscle aches; respiratory symptoms, such as cough, sore throat, runny or stuffy nose; and fatigue.
[0010] The present invention provides the composition comprising thimerosal free of association with influenza virus to be administered in a dosage of from 0.05 μg to 500 μg, or more preferably 0.05 μg to 50 μg, or most preferably 0.2 μg. Also provided is the administration of the thimerosal composition in a single dose of 0.05 cc in a pharmaceutically acceptable carrier or excipient.
[0011] The methods of the invention may be used to treat Influenza A viruses generally as well as Influenza A H5N1 strain viruses sometimes referred to as "avian influenza."
[0012] The present invention also provides methods for administration of the thimerosal composition comprising sublingual or subcutaneous administration.
Detailed Description of the Preferred Embodiments
[0013] Thimerosal can be used for treating subjects suffering from influenza virus infections by administering an effective amount of a composition comprising thimerosal, free of association with influenza virus. In preferred embodiments, the thimerosal is formulated in compositions that include at least one pharmaceutically acceptable diluent, adjuvant, or carrier substance, using any available pharmaceutical chemistry techniques. Generally, this entails preparing compositions that are essentially free of pyrogens, as well as other impurities that could be harmful to humans or animals.
[0014] As used herein, "pharmaceutically acceptable carrier or excipient" includes any and all solvents, dispersion media, coatings, antibacterial and antifungal agents, isotonic and absorption delaying agents and the like. The use of such media and agents for pharmaceutical active substances is well known in the art. Except insofar as any conventional media or agent is incompatible with the active ingredient, its use in the therapeutic compositions is contemplated. Supplementary active ingredients also can be incorporated into the compositions.
[0015] Administration of thimerosal used in the pharmaceutical composition to practice the method of the present invention can be carried out in a variety of conventional ways, such as oral ingestion, sublingual application, subcutaneous, intraperitoneal, parenteral or intravenous injection. Sublingual administration to the subject is preferred. The treatment may consist of a single dose or a plurality of doses over a period of time.
[0016] For oral administration, the compounds can be formulated readily by combining thimerosal with pharmaceutically acceptable carriers well known in the art. Such carriers enable the compounds of the invention to be formulated as tablets, pills, dragees, capsules, liquids, gels, syrups, slurries, suspensions and the like, for oral ingestion by a subject to be treated. Pharmaceutical preparations for oral use can be obtained using a solid excipient, optionally grinding a resulting mixture, and processing the mixture of granules, after adding suitable auxiliaries, if desired, to obtain tablets or dragee cores. Suitable excipients are, in particular, fillers such as sugars, including lactose, sucrose, mannitol, or sorbitol; cellulose preparations such as, for example, maize starch, wheat starch, rice starch, potato starch, gelatin, gum tragacanth, methyl cellulose, hydroxypropylmethyl cellulose, sodium carboxymethylcellulose, and/or polyvinylpyrrolidone (PVP). If desired, disintegrating agents may be added, such as the cross linked polyvinyl pyrrolidone, agar, or alginic acid or a salt thereof such as sodium alginate. Dragee cores are provided with suitable coatings. For this purpose, concentrated sugar solutions may be used, which may optionally contain gum arabic, talc, polyvinyl pyrrolidone, carbopol gel, polyethylene glycol, and/or titanium dioxide, lacquer solutions, and suitable organic solvents or solvent mixtures.
[0017] Pharmaceutical preparations which can be used orally include push fit capsules made of gelatin, as well as soft, sealed capsules made of gelatin and a plasticizer, such as glycerol or sorbitol. The push fit capsules can contain the thimerosal in a mixture with filler such as lactose, binders such as starches, and/or lubricants such as talc or magnesium stearate and, optionally, stabilizers, hi soft capsules, the active compounds may be dissolved or suspended in suitable liquids, such as fatty oils, liquid paraffin, or liquid polyethylene glycols. Li addition, stabilizers may be added. All formulations for oral administration should be in dosages suitable for such administration.
[0018] Pharmaceutical formulations for parenteral administration include aqueous solutions of thimerosal. Aqueous injection suspensions may contain substances which increase the viscosity of the suspension, such as sodium carboxymethyl cellulose, sorbitol, or dextran. Optionally, the suspension may also contain suitable stabilizers or agents which increase the solubility of the compounds to allow for the preparation of highly concentrated solutions. Alternatively, the thimerosal may be in powder form for constitution with a suitable vehicle, e.g., sterile pyrogen free water, before use.
[0019] The pharmaceutical compositions also may comprise suitable solid or gel phase carriers or excipients. Examples of such carriers or excipients include but are not limited to calcium carbonate, calcium phosphate, various sugars, starches, cellulose derivatives, gelatin, and polymers such as polyethylene glycols.
[0020] Appropriate dosages may be ascertained through the use of established assays for determining dose-response and toxicity and side-effect data. Typically, a pharmaceutical dosage unit of the present invention for the delivery of thimerosal comprises a liquid or solid carrier and an effective amount of thimerosal. One suitable carrier for sublingual administration comprises a phenylated saline solution. Effective amounts of thimerosal range from about 0.05 μg to 500 μg thimerosal with about 0.1 μg to about 50 μg thimerosal being preferred and about 0.2 μg thimerosal being particularly preferred. [0021] It will be appreciated that the treatment methods of the invention may be useful in fields of veterinary and human medicine. Thus the subject to be treated may be a chordate including birds and poultry; a mammal, including pigs and humans or other animals. For veterinary purposes, subjects include for example, farm animals including cows, sheep, pigs, horses and goats, companion animals such as dogs and cats, exotic and/or zoo animals, laboratory animals including mice rats, rabbits, guinea pigs and hamsters; and poultry such as chickens, turkey ducks and geese.
[0022] The following examples are illustrative and are not intended to limit either the scope or spirit of the invention.
Example
[0023] According to this example a 67 year old female presented with the symptoms of classic influenza which had appeared two days previously. The subject was treated by a regimen of sublingual administration of a composition comprising 0.2 micrograms of thimerosal in 1 drop (0.05 ml) of saline. The composition was administered at a rate of one drop every 15 minutes for an hour followed by one drop per hour until bedtime. On the second day of treatment the subject was treated with one drop per hour, as needed. The subject's fever normalized by the end of the first day and the aches associated with influenza were reported to have improved by the second day. By the third day, the patient reported that she was "back to normal."
[0024] Treatment of other subjects resulted in similar results with the length of time during which subjects suffering from the symptoms of influenza being reduced from an average of 7-12 days to 1 or 2 days post treatment. Still further experiments using the same quantities of the thimerosal containing composition showed similar results.
[0025] Numerous modifications and variations in the practice of the invention are expected to occur to those skilled in the art upon consideration of the presently preferred embodiments thereof. Consequently, the only limitations which should be placed upon the scope of the invention are those which appear in the appended claims.

Claims

What Is Claimed Is:
1. A method for treating a subject suffering from an influenza virus infection, comprising administering to said subject an effective amount of a therapeutic composition comprising: thimerosal, free of association with an influenza virus vaccine; and a pharmaceutically acceptable carrier or excipient.
2. The method of claim 1, wherein from 0.05 μg to 500 μg of thimerosal is administered per dose.
3. The method of claim 1, wherein from 0.1 μg to 50 μg of thimerosal is administered per dose.
4. The method of claim 1, wherein 0.2 μg of thimerosal is administered per dose.
5. The method of claim 1, wherein said composition is administered to a patient in a single dose of 0.05 cc in a pharmaceutically acceptable carrier.
6. The method of claim 1 , wherein the composition is administered sublingually.
7. The method of claim 1, wherein the composition is administered subcutaneously.
8. The method of claim 1 wherein the Influenza virus is an Influenza A virus.
9. The method of claim 8 wherein the Influenza A virus is an H5N1 virus.
PCT/US2006/034640 2005-10-13 2006-09-06 Methods for the treatment of influenza WO2007046966A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US72711105P 2005-10-13 2005-10-13
US60/727,111 2005-10-13

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WO2007046966A3 WO2007046966A3 (en) 2007-10-11

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Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040053999A1 (en) * 1997-09-17 2004-03-18 Bischofberger Norbert W. Novel compounds and methods for synthesis and therapy
US7166435B2 (en) * 2001-08-06 2007-01-23 The Quigley Corporation Compositions and methods for reducing the transmissivity of illnesses

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