Anti-viral composition

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai

Reexamination Certificate

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Details

C514S001000, C514S04400A, C530S300000, C530S350000, C536S022100, C536S023100

Reexamination Certificate

active

06500808

ABSTRACT:

FIELD OF THE INVENTION
The invention relates to compositions for the treatment or prevention of viral infection. The invention also relates to compositions for the treatment of tumors.
BACKGROUND
Illnesses resulting from viral infection remain as a major problem to be addressed by modern medicine. To date, there is no 100% effective treatment for infection with any known virus. Recently there has been progress towards treatment of several viral diseases, but these treatments are largely directed at specific viruses or classes of viruses. For example, protease inhibitors targeting the virally-encoded human immunodeficiency virus (HIV) protease have been effective against some strains of HIV, and have been responsible, when used in combination with other anti-viral agents, for a decline in HIV-related deaths in the United States. However, the protease inhibitors are specific for specific viruses or classes of viruses, and are not useful for the treatment of viruses outside of those classes. In addition, there is evidence that strains resistant to these new agents are evolving.
It is noted that the virus-specific agents currently being used in developed countries are very expensive, being beyond the means of a great number of infected individuals throughout the world. In addition, the dosage regimens are complex and demand careful attention by physicians and the infected individuals.
Because viruses co-opt the host's own normal intracellular metabolic processes for their reproductive needs, a major difficulty in the design of antiviral agents is to make agents that target the virus without toxicity to the host organism.
There is a need in the art for antiviral agents that are effective against a broad spectrum of viruses, relatively non-toxic, inexpensive to produce, and simple to administer.
Many of the same problems plaguing those attempting to develop antiviral therapies are faced by those wishing to cure cancer. Transformed cancer cells share the same cellular metabolic processes as non-transformed cells, differing primarily in a loss of normal growth control. Therefore, it has been difficult to develop treatment strategies that are effective against tumor cells without significant toxicity to non-tumor cells. There is a need in the art for effective anti-tumor therapies that minimize the toxicity to non-transformed cells and tissues.
SUMMARY OF THE INVENTION
The invention relates to methods and compositions for treating the symptoms of viral infection and for reducing the size or cellular load of a tumor.
More specifically, the invention encompasses a composition comprising the chemical compounds of Structure Nos. 1-4 and analogs thereof with antiviral activity. The invention also encompasses a composition consisting essentially of any one or a combination of the chemical compounds of Structure Nos. 1-4. The invention also encompasses a composition comprising at least 10%, 20%, 50%, 75%, 90%, 95% or 99% of any one or a combination of structures 1-4 by weight. Structures 1 and 2 are chiral, as are structures 3 and 4. A composition of the invention may have relative amounts of (Structures 1 and 2): (Structures 3 and 4) in proportions ranging from 1:100, 1:10, 1:1, 10:1, or even 100:1.
The invention also encompasses an antiviral composition comprising a mixture of zinc oxide, aspartic acid, and high fructose corn syrup.
In one embodiment, the composition comprising a mixture of zinc oxide, aspartic acid, and high fructose corn syrup comprises one mass unit of zinc oxide, about 2.5 mass units of aspartic acid, and about 64.5 mass units of high fructose corn syrup.
The invention further encompasses an antiviral composition consisting essentially of a mixture of zinc oxide, aspartic acid and high fructose corn syrup.
In a preferred embodiment, the high fructose corn syrup has the following characteristics: a) about 77% solids and about 23% moisture; and b) a carbohydrate composition as follows: about 55% fructose; about 41% dextrose; the remainder being higher saccharides. In another embodiment, pure fructose (i.e., a composition consisting essentially of fructose), or a composition comprising about 96% fructose and 4% higher polysaccharides, is used in the preparation of an antiviral composition of the invention.
The invention further encompasses a method of making an antiviral or antitumor composition, such method comprising the steps of: a) combining zinc oxide, aspartic acid and high fructose corn syrup to form a mixture; b) heating the mixture until visible insoluble material is absent; and c) dehydrating the resulting composition to less than or equal to 1.5% water.
In a preferred embodiment of the method, the step of heating comprises the sequential steps of: a) heating the mixture to 170° F. for 10 minutes; b) heating the mixture to 180° F. for 15 minutes; and c) heating the mixture to 190° F. for 3 to 5 hours, until no insoluble material is visible to the naked eye.
In a preferred embodiment of the method, the mixture of step (a) comprises one mass unit of zinc oxide, about 2.5 mass units of aspartic acid, and about 64.5 mass units of high fructose corn syrup.
In a further preferred embodiment of the method, the high fructose corn syrup has the following characteristics: a) about 77% solids and 23% moisture; and b) a carbohydrate composition as follows: about 55% fructose, about 41% dextrose, with the remainder being higher saccharides.
The invention further encompasses a method of reducing the duration of symptoms of viral infection, the method comprising the step of administering a therapeutically effective amount of a composition comprising a chemical compound selecting form the group consisting of structures 1-4 or an analog thereof having antiviral activity, such that the duration of the symptoms is reduced.
In a preferred embodiment, the virus is one which causes the common cold.
In another preferred embodiment, the virus is herpes zoster (varicella zoster).
The invention further encompasses a method of reducing the titer of a virus in a virally infected individual, the method comprising the step of administering a therapeutically effective amount of a composition comprising, selected from the group consisting of structure 1-4 an analog thereof, such that the titer of the virus in the individual is reduced.
The invention further encompasses a method of increasing the number of CD4
+
T cells in an individual infected with human immunodeficiency virus, the method comprising the step of administering a therapeutically effective amount of a composition selected from the group consisting of structure 1-4 an analog thereof, such that the number of CD4
+
T cells is increased.
The invention further encompasses a method of maintaining the number of CD4
+
T cells in an individual infected with human immunodeficiency virus, the method comprising the step of administering a therapeutically effective amount of a composition selected from the group consisting of structure 1-4 an analog thereof, such that the number of CD4
+
T cells is maintained.
The invention further encompasses a method of reducing the size of a tumor in an individual, the method comprising the step of administering a therapeutically effective amount of a composition selected from the group consisting of structure 1-4 an analog thereof, such that the size of the tumor is reduced.
In preferred embodiments of the methods of reducing the duration of symptoms of viral infection, reducing the titer of a virus, increasing or maintaining CD4
+
T cells, or reducing the size or cellular load of a tumor, the composition is administered transmucosally.
In other preferred embodiments of the methods of reducing the duration of symptoms of viral infection, reducing the titer of a virus, increasing or maintaining CD4
+
T cells, or reducing the size or cellular load of a tumor, the composition is administered parenterally.
The invention further encompasses a kit for performing the methods of reducing the duration of symptoms of viral infection, reducing the titer of a virus, increasing

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