Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
  • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• • 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
  • A61K31/13—Amines
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P11/00—Drugs for disorders of the respiratory system
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P11/00—Drugs for disorders of the respiratory system
  • A61P11/02—Nasal agents, e.g. decongestants
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P11/00—Drugs for disorders of the respiratory system
  • A61P11/06—Antiasthmatics
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P13/00—Drugs for disorders of the urinary system
  • A61P13/12—Drugs for disorders of the urinary system of the kidneys
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P27/00—Drugs for disorders of the senses
  • A61P27/16—Otologicals
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
  • A61P31/04—Antibacterial agents
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
  • A61P31/12—Antivirals
  • A61P31/14—Antivirals for RNA viruses
  • A61P31/16—Antivirals for RNA viruses for influenza or rhinoviruses
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P9/00—Drugs for disorders of the cardiovascular system
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P9/00—Drugs for disorders of the cardiovascular system
  • A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P9/00—Drugs for disorders of the cardiovascular system
  • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Definitions

• Influenza commonly known as the '"flu,' * is a contagious disease that is caused by the influenza virus, classified in the orthomyxoviridae family.
• Influenza A There are three known influcnza- typc viruses which affect human beings: Influenza A, B and C.
• Influenza A viruses have been isolated from many animal species in addition to humans, while the influenza B and C viruses have been found to infect mainly humans.
• Influenza viruses are enveloped viruses containing negative single-stranded RNA's which are segmented and encapsidated.
• 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
• Influenza viruses attack the respiratory tract in humans (i.e., nose, throat, and lungs).
• Influenza infection usually includes the following symptoms: fever, headache, tiredness (can be extreme), dry cough, sore throat, nasal congestion, and body aches.
• U.S. residents get influenza each year. The majority of this population generally recovers in one to two weeks. In some cases, however, complications can arise from an influenza infection.
• Those persons at highest risk for contracting complications from the flu include: persons over 50 years of age, children aged 6 to 23 months, women more than 3 months pregnant, persons living in a long-term care facility or institution, persons with chronic heart, lung, or kidney conditions, diabetes, or weakened immune system. Pneumonia, bronchitis, encephalitis, otitis media, rhinitis, and sinusitis are only a few examples of complications that result from an influenza infection.
• the flu can make chronic health problems worse. For example, people with asthma may experience asthma attacks while they have the flu, and people with chronic congestive heart failure may have worsening of this condition that is triggered by the flu.
• influenza viruses have a major impact on morbidity leading to increases in hospitalization and in visits to health care providers. For example, high rates of hospitalization are often observed for subjects over 65 years of age and also for children less than 5 years of age.
• influenza virus causes a worldwide epidemic.
• influenza pandemic of 1918 reportedly caused about 20 million deaths worldwide and about 500,000 deaths in the United States (Medical Microbiology, Fourth Edition, University of Texas Medical Branch at Galveston (1996)).
• Influenza viruses are predominantly transmitted from person to person via respiratory droplets (also known as droplet spread) that are released as a result of coughing and/or sneezing.
• the influenza virus can remain suspended in the air in respiratory droplets for as long as 3 hours; but are sensitive to heat and are rapidly inactivated at temperatures above 50 0 C.
• the virus can survive for 24-48 hours on hard, non-porous surfaces (i.e., telephone receivers, computer keyboard, doorknob, kitchen countertop, toys); 8 hours on cloth, paper and tissue; and five minutes on hands (see Muir, P, "Treatment of Influenza. Essential CPE. Continuing Education from the Pharmaceutical Society of Australia," Paragon Printers, Australasia, ACT (2002)).
• Typical methods of transmittal include mucous membrane contact with infected airborne respiratory droplets, person-to-person contact, contact with contaminated items (i.e., tissues soiled by infected nose and throat discharges).
• Transmittal of influenza virus via respiratory droplets can occur as early as one day before a person experiences influenza-related symptoms.
• Adults can continue to transmit the virus to others for another three to seven days after the initial appearance of symptoms. Unlike adults, children have the ability to transmit the virus for longer than seven days.
• Symptoms are generally presented one to four days after the virus enters the body. In certain cases, a person can be infected with the flu virus but demonstrate no symptoms. During this time, those persons can still transmit the virus to others.
• Avian influenza is an infection caused by avian (bird) influenza (flu) viruses. These influenza viruses occur naturally among birds. Avian influenza is very contagious among birds and can cause sickness and death in certain domesticated birds, including chickens, ducks, and turkeys. Because these viruses do not commonly infect humans, there is little or no immune protection against them in the human population. Of the few avian influenza viruses that have crossed the species barrier to infect humans, the strain known as H5N1 has caused the largest number of detected cases of severe disease and death in humans. Of the human cases associated with the ongoing H5N1 outbreaks in poultry and wild birds in Asia and parts of Europe, the Near East and Africa, more than half of those people reported infected with the virus have died.
• H5N1 virus Because all influenza viruses have the ability to change, scientists are concerned that H5N1 virus one day could be able to infect humans and spread easily from one person to another. If H5N1 virus were to gain the capacity to spread easily from person to person, an influenza pandemic (worldwide outbreak of disease) could begin.
• the subject invention provides materials and methods for treating subjects diagnosed with influenza infections as well as preventing the onset of influenza infections. In one embodiment, the invention provides methods for the treatment of influenza symptoms. In another embodiment, the subject invention provides methods for the prevention or delay in development of influenza related complications.
• the subject invention provides methods for the treatment and/or prevention of avian influenza infections and related symptoms.
• materials and methods for the treatment of infections with the H5N1 strain of avian influenza are materials and methods for the treatment of infections with the H5N1 strain of avian influenza.
• a preferred embodiment of the subject invention provides a method for the treatment and/or prevention of influenza infections wherein the method involves the concurrent administration to a subject of a cysteamine compound and a second therapeutic agent useful in the treatment of viral infections.
• the second therapeutic agent to be used in conjunction with the cysteamine compound can be, for example, a vaccine, a neuraminidase inhibitor, or hemagglutinin inhibitor.
• a cysteamine compound and a second viral therapeutic arc concurrently administered to a subject prior to, during, or after exposure to an influenza virus.
• antitussives, mucolytics, expectorants, antipyretics, analgesics, and/or nasal decongestants can also be administered with cysteamine and the second viral therapeutic.
• the subject invention is applicable to both human and animal health, especially to humans and animals infected by an influenza virus.
• viruses common to non-human animals can be treated and/or prevented in humans or animals using the present invention: swine influenza virus, equine influenza virus, equine influenza virus, avian influenza virus, feline influenza or coryza, and the like, including any mutants thereof.
• a cysteamine compound concurrently with a neuraminidase or hemagluttinin inhibitor (such as oseltamivir phosphate; TAMIFLU®) to a subject prior to acquiring the influenza virus can help protect the subject from influenza infection, or at least ensure that symptoms related to influenza virus disease develop to a lesser extent than would be observed in the absence of the cysteamine compound and the second viral therapeutic, e.g., neuraminidase or hemagglutinin inhibitor.
• a neuraminidase or hemagluttinin inhibitor such as oseltamivir phosphate; TAMIFLU®
• the present invention provides methods for the treatment and/or prevention of an avian influenza viral infection; the alleviation of avian influenza viral infection-related symptoms; as well as the prevention or delay in development of avian influenza viral infection-related complications via the concurrent administration of a cysteamine compound and a viral therapeutic.
• Figure 2 shows a metabolic pathway of cysteamine.
• the subject invention provides materials and methods for preventing and/or treating viral infections. Specifically, the subject invention provides materials and methods for preventing influenza infection; treating/ameliorating symptoms associated with influenza infections; and/or preventing/delaying the onset of complications associated with influenza infections. In preferred embodiments, the invention provides methods for preventing an avian influenza infection, treating/ameliorating symptoms associated with an avian influenza infection, as well as preventing/delaying the onset of complications associated with an avian influenza infection.
• a cysteamine compound is concurrently administered with a second viral therapeutic to a subject diagnosed with an influenza infection to alleviate influenza-related symptoms.
• a "viral therapeutic” is a treatment that treats and/or prevents an influenza virus disease.
• a cysteamine compound and a second viral therapeutic are administered to a subject prior to infection in order to prevent an influenza infection.
• a cysteamine compound is concurrently administered with a neuraminidase or hemagglutinin inhibitor to prevent, delay, and/or treat an influenza infection or the development of influenza-related complications in subjects who are at an increased risk of contracting those complications.
• a cysteamine compound is administered concurrently with another viral therapeutic useful in the treatment and/or prevention of the various subtypes of avian influenza virus (ATV). More preferably, a cysteamine compound of the invention is administered concurrently with another viral therapeutic useful in the treatment and/or prevention of H5N1 AIV.
• a dosage of at least 0.1 mg/mL of cysteamine hydrochloride, more preferably at least 1 mg/mL of cysteamine hydrochloride, and even more preferably at least 2 mg/mL of cysteamine hydrochloride can be administered concurrently with another viral therapeutic to a subject to treat and/or prevent an AIV infection, preferably an H5N1 AIV infection.
• symptom(s) refers to signs or indications that a subject is suffering from a specific condition or disease.
• symptoms associated with an influenza infection refer to signs or indications that a subject is infected with an influenza virus.
• Influenza-related symptoms contemplated herein include, but are not limited to, fever, headache, exhaustion/fatigue, muscular aches, sore joints, irritated watering eyes, malaise, nausea and/or vomiting, shaking, chills, chest pain, sneezing and respiratory symptoms (i.e., inflamed respiratory mucous membranes, substernal burning, nasal discharge, scratchy/sore throat, dry cough, loss of smell).
• Symptoms associated with an influenza infection can start within 24 to 48 hours after infection and can begin suddenly. Chills or a chilly sensation are often the first indication of influenza. Fever is common during the first few days, and the temperature may rise to 102 0 F to 103 0 F. In many instances, subjects feel sufficiently ill to remain in bed for days; subjects often experience aches and pains throughout the body, most pronounced in the back and legs.
• the term “complication(s) " ' refers to a pathological process or event occurring during a disease or condition that is not an essential part of the disease or condition; where it may result from the disease/condition or from independent causes. Accordingly, the term complication(s) refers to medical/clinical problems that arc observed in subjects diagnosed with an influenza infection.
• One complication of an influenza infection is that the influenza infection can make chronic health problems worse.
• complications associated with an influenza infection include, without limitation, encephalitis, bronchitis, tracheitis, myositis rhinitis, sinusitis, asthma, bacterial infections (i.e., streptococcus aureus bacterial infection, haemophilus influenzae bacterial infection, staphylococcal pneumonia bacterial infection), cardiac complications ⁇ i.e., atrial fibrillation, myocarditis, pericarditis), Reye's syndrome, neurologic complications ⁇ i.e., confusion, convulsions, psychosis, neuritis,
• Guillain-Barre syndrome coma, transverse myelitis, encephalitis, encephalomyelitis), toxic shock syndrome, myositis, myoglobinuria, and renal failure, croup, otitis media, viral infections (i.e., viral pneumonia), pulmonary fibrosis, obliterative bronchiolitis, bronchiectasis, exacerbations of asthma, exacerbations of chronic obstructive pulmonary disease, lung abscess, empyema, pulmonary aspergillosis, myositis and myoglobinaemia, heart failure, early and late fetal deaths in pregnant women, increased perinatal mortality in pregnant women, and congenital abnormalities in birth.
• viral infections i.e., viral pneumonia
• pulmonary fibrosis obliterative bronchiolitis
• bronchiectasis exacerbations of asthma
• exacerbations of chronic obstructive pulmonary disease
• influenza refers to an RNA vims of the Orthomyxoviridae family, including influenza A, influenza B, and influenza C, and mutants thereof.
• Influenza viruses contemplated herein include those viruses that have two antigenic glycosylated enzymes on their surface: neuraminidase and hemagglutinin.
• HlNl H1N2, H2N2, H3N2, H3N8, H5N1, H5N3, H5N8, H5N9, H7N1, H7N2, H7N3, H7N4, H7N7, H9N2, and H10N7 subtypes including the following subtypes commonly known as the "Spanish Flu,” "Asian
• subject describes an organism, including humans, birds, and mammals, to which treatment with the compositions according to the present invention is provided.
• Species that benefit from the disclosed methods of treatment include, but are not limited to, apes, chimpanzees, orangutans, humans, monkeys; and domesticated animals (i.e., pets) such as dogs, cats, horses, pigs, mice, rats, guinea pigs, hamsters, chickens, ducks, geese, and the like.
• Concurrent administration includes administering a cysteamine compound and second viral therapeutic together in a manner suitable for the treatment of a influenza infection or for the treatment of influenza infection-related symptoms/complications.
• concurrent administration includes providing to a subject a cysteamine compound and a second viral therapeutic as separate compounds, such as, for example, separate pharmaceutical compositions administered consecutively, simultaneously, or at different times.
• the cysteamine compound and another viral therapeutic are administered separately, they are not administered so distant in time from each other that the cysteamine compound and the viral therapeutic cannot interact.
• concurrent administration also encompasses providing another viral therapeutic in admixture with a cysteamine compound, such as in a pharmaceutical composition.
• a cysteamine compound and second viral therapeutic are administered together at the same time.
• a second viral therapeutic of the invention includes vaccinations or antiviral medications such as a neuraminidase or hemagglutinin inhibitor.
• Contemplated viral therapeutics for use in accordance with the subject invention include, but are not limited to, amantadine, rimantadine, ribavirin, idoxuridine, trifluridine, vidarabine, acyclovir, ganciclovir, foscarnet, zidovudine, didanosine, zalcitabine, stavudine, famciclovir, oseltamivir, zanamivir, and valaciclovir.
• the second viral therapeutic is oseltamivir phosphate.
• a cysteamine compound is concurrently administered with another viral therapeutic and other therapeutics useful in the treatment of symptoms associated with an influenza infection.
• another viral therapeutic and other therapeutics useful in the treatment of symptoms associated with an influenza infection.
• antitussives, mucolytics, expectorants, antipyretics, analgesics, or nasal decongestants can be concurrently administered with a cysteamine compound and second viral therapeutic to a subject diagnosed with an influenza infection.
• cysteamine As used herein, reference to a "cysteamine compound " ' includes cysteamine, the various cysteamine salts, which include pharmaceutically acceptable salts of a cysteamine compound, as well as prodrugs of cysteamine that can, for example, be readily metabolized in the body to produce cysteamine. Also included within the scope of the subject invention are analogs, derivatives, conjugates, and metabolic precursors (such as cysteine, cystamine, pantethine, and the like) as well as metabolites (such as taurine, hypotaurine, and the like) of cysteamine, which have the ability as described herein to treat and/or prevent stress and stress-related symptoms/complications by lowering Cortisol levels as well as augment immune activity.
• analogs, derivatives, conjugates, and metabolic precursors such as cysteine, cystamine, pantethine, and the like
• metabolites such as taurine, hypotaurine, and the like
• a cysteamine compound includes pantothenic acid.
• Pantothenic acid is a naturally occurring vitamin that is converted in mammals to coenzyme A, a substance vital to many physiological reactions.
• Cysteamine is a component of coenzyme A, and increasing coenzyme A levels results in increased levels of circulating cysteamine.
• Alkali metal salts such as magnesium phosphate tribasic and magnesium sulphite (Epsom salts), enhance formation of coenzyme A.
• breakdown of coenzyme A to cysteamine is enhanced by the presence of a reducing agent, such as citric acid.
• a reducing agent such as citric acid.
• pharmaceutically acceptable salt refers to any salt of a cysteamine compound that is pharmaceutically acceptable and does not greatly reduce or inhibit the activity of the cysteamine compound. Suitable examples include acid addition salts, with an organic or inorganic acid such as acetate, tartrate, trifluoroacetate, lactate, maleate, fumarate, citrate, methane, sulfonate, sulfate, phosphate, nitrate, or chloride.
• the advantages of cysteamine can be achieved by promoting the endogenous production of cysteamine through natural metabolic process such as through the action of co-enzyme A or as a precursor and/or metabolite of cysteine (see Figures 1 and 2). This can be achieved by, for example, the administration of pantothenic acid.
• the term "effective amount,” as used herein, refers to the amount necessary to elicit the desired biological response.
• the effective amount of a cysteamine compound and another viral therapeutic is the amount necessary to treat/prevent an influenza viral infection; treat/ameliorate symptoms associated with influenza viral infections; and/or prevent/delay/ameliorate the onset of complications associated with influenza viral infections.
• the effective amount of a cysteamine compound and second viral therapeutic is the amount necessary to treat/prevent an avian influenza infection; treat/ameliorate symptoms associated with avian influenza infection; and/or prevent/delay/ameliorate the onset of complications in patients with increased risk for contracting complications associated with avian influenza infection.
• the amelioration in symptom and/or complication severity may be a 5%, 10%, 15%, 20%, 25% 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 98% or 99% decrease in severity.
• the present invention is particularly applicable to non-human subject health, especially to non-human subjects infected with an influenza virus.
• non-human subjects inflected with influenza virus can be treated and/or prevented using the present invention: chickens, ducks, geese, pheasants, cats, dogs, pigs, sheep, and other agriculture animals.
• the present invention is particularly applicable to the treatment and/or prevention of influenza virus infections, especially avian influenza virus infections.
• concurrent administration of a cysteamine compound and second viral therapeutic is useful in the treatment and/or prevention of various avian influenza strains, including viruses of subtype HlNl, H1N2, H2N2, H3N2, H3N8,
• cysteamine hydrochloride and another viral therapeutic are concurrently administered to subjects (either human or animal) in order to treat and/or prevent a H5N1 avian influenza virus infection.
• a cysteamine compound (such as cysteamine hydrochloride) is administered concurrently with a neuraminidase or hemagglutinin inhibitor to treat and/or prevent an avian influenza viral infection.
• a cysteamine compound is concurrently administered with a neuraminidase inhibitor (such as oseltamivir phosphate) via injection or oral administration.
• the dosage of cysteamine and viral therapeutic administered to a subject to elicit a desired response is about 10 mg to about 3,000 mg per day for each.
• the desired response can include (1) prevention of influenza viral infections; preferably avian influenza infection; (2) a reduction in the severity, duration, or intensity of symptoms associated with influenza infections, preferably symptoms associated with avian influenza infection; and (3) prevention, delay, or reduction in the severity, duration, or intensity of complications related to an influenza viral infections, particularly complications related to avian influenza infections.
• a cysteamine compound and a second viral therapeutic are each administered at about 50 mg to 1 ,500 mg per day to elicit a desired response from a subject.
• cysteamine hydrochloride and another viral therapeutic are concurrently administered daily to elicit a desired response (e.g., prevent/treat the onset of an influenza infection such as avian influenza virus, influenza A, influenza B, and influenza C or any mutants thereof).
• a dosage of at least 0.1 mg/mL of cysteamine hydrochloride, more preferably at least 1 mg/mL of cysteamine hydrochloride, and even more preferably at least 2 mg/mL of cysteamine hydrochloride can be concurrently administered with another viral therapeutic to a subject to treat and/or prevent a H5N1 AlV infection.
• the dosage of cysteamine hydrochloride administered concurrently with a second viral therapeutic in the treatment and/or prevention of an AlV infection including viruses of subtype HlNl, H1N2, H2N2, H3N2, H3N8, H5N1,
• H5N2, H5N3, H5N8, H5N9, H7N1, H7N2, H7N3, H7N4, H7N7, H9N2, and H10N7) correlates to the concentration of virus present in the subject. More preferably, the dosage of cysteamine hydrochloride administered in the treatment and/or prevention of a H5N1 AIV infection correlates to a concentration of about LD50 of virus present in the subject.
• the compositions of the subject invention can include an effective amount of a cysteamine compound and second viral therapeutic.
• compositions can be used in a variety of routes of administration, including, for example, orally-administrable forms such as tablets, capsules or the like, or via parenteral, intravenous, intramuscular, transdermal, buccal, subcutaneous, suppository, or other route.
• routes of administration including, for example, orally-administrable forms such as tablets, capsules or the like, or via parenteral, intravenous, intramuscular, transdermal, buccal, subcutaneous, suppository, or other route.
• pharmaceutical compositions Typically, they can be in unit dosage form, namely, in physically discrete units suitable as unitary dosages for human consumption, each unit containing a predetermined quantity of active ingredient calculated to produce the desired therapeutic effect in association with one or more pharmaceutically acceptable other ingredients, i.e., diluent or carrier.
• the cysteamine and viral therapeutic compositions of the subject invention can be formulated according to known methods for preparing pharmaceutically useful compositions.
• Formulations are described in a number of sources, which are well known and readily available to those skilled in the art.
• Remington 's Pharmaceutical Science (Martin EW [1995] Easton Pennsylvania, Mack Publishing Company, 19 th ed.) describes formulations that can be used in connection with the subject invention.
• Formulations suitable for parenteral administration include, for example, aqueous sterile injection solutions, which may contain antioxidants, buffers, bacteriostats, and solutes, which render the formulation isotonic with the blood of the intended recipient; and aqueous and nonaqueous sterile suspensions, which may include suspending agents and thickening agents.
• the formulations may be presented in unit-dose or multi-dose containers, for example sealed ampoules and vials, and may be stored in a freeze dried (lyophilized) condition requiring only the condition of the sterile liquid carrier, for example, water for injections, prior to use.
• sterile liquid carrier for example, water for injections, prior to use.
• Extemporaneous injection solutions and suspensions may be prepared from sterile powder, granules, tablets, etc. It should be understood that in addition to the ingredients particularly mentioned above, the formulations of the subject invention can include other agents conventional in the art having regard to the type of formulation in question.
• the formulations comprising a cysteamine compound and another viral therapeutic include those suitable for oral, rectal, nasal, topical (including buccal and sublingual), vagina], parenteral (including subcutaneous, intramuscular, intravenous, intradermal, intrathecal and epidural) administration as well as administration to the eye.
• the formulations may conveniently be presented in unit dosage form and may be prepared by any of the methods well known in the art of pharmacy. Such methods include the step of bringing into association the cysteamine compound and second viral therapeutic with the carrier which constitutes one or more accessory ingredients.
• the formulations are prepared by uniformly and intimately bringing into association the cysteamine compound and second viral therapeutic with liquid carriers or finely divided solid carriers or both, and then, if necessary, shaping the product.
• the cysteamine compound and second viral therapeutic are provided in a formulation for use in a skin patch.
• a cysteamine compound and another viral therapeutic in accordance with the subject invention, can be accomplished by any suitable method and technique presently or prospectively known to those skilled in the art.
• a cysteamine compound and second viral therapeutic are formulated together in a palatable and easily consumed oral formulation such as a pill, lozenge, tablet, gum, beverage, etc. The consumption is then taken at or after experiencing an influenza infection- related symptom and/or when needed to prevent an influenza infection.
• compositions of the invention preferably include as an active ingredient, an effective amount of the cysteamine compound, the second viral therapeutic, and one or more nontoxic, pharmaceutically acceptable carrier or diluent.
• carriers for use in the invention include ethanol, dimethyl sulfoxide, glycerol, silica, alumina, starch, sorbitol, inosital, xylitol, D-xylose, manniol, powdered cellulose, microcrystalline cellulose, talc, colloidal silicon dioxide, calcium carbonate, magnesium cabonate, calcium phosphate, calcium aluminium silicate, aluminium hydroxide, sodium starch phosphate, lecithin, and equivalent carriers and diluents.
• compositions of the invention will typically comprise between about 0.1% and 95%, of the total composition including carrier or diluent.
• the dosage used can be varied based upon the age, weight, health, or the gender of the individual to be treated.

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• 2008
  • 2008-05-27 CN CN200880021533A patent/CN101842092A/zh active Pending
  • 2008-05-27 JP JP2010509585A patent/JP2010528053A/ja active Pending
  • 2008-05-27 US US12/600,264 patent/US20100151042A1/en not_active Abandoned
  • 2008-05-27 WO PCT/US2008/064860 patent/WO2009023356A2/en not_active Ceased

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