WO2001000194A2

WO2001000194A2 - A method for optimizing immune activity in the treatment of auto-immune diseases and chronic immune conditions

Info

Publication number: WO2001000194A2
Application number: PCT/IB2000/000791
Authority: WO
Inventors: Robert H. Jacobs
Original assignee: Individual
Current assignee: Individual
Priority date: 1999-06-29
Filing date: 2000-06-13
Publication date: 2001-01-04
Anticipated expiration: 2001-12-29
Also published as: AU4944500A; WO2001000194A3

Abstract

A method and composition for optimizing immune activity in the treatment of chronic immune conditions wherein the chronic immune conditions is Hepatitis-C. A method and composition is described for reducing the inflammation and the viral activity in the hepatocytes in living mammals, and for reducing the number of carcinogenic free radicals including hydroxyl and super oxide anions in living mammals, and for enhancing the immune system in HIV/Aids infected individuals by enhancing the bodily mechanisms including intracellular communication, gene regulation, gene repair and membrane effects. A method and composition for optimizing immune activity under conditions of chronic immune conditions in the treatment of such chronic immune conditions wherein the chronic immune conditions include Hepatitis-C, Cancer, AIDS/HIV, Herpes, Colds, Influenza, Bronchitis, Chronic fatigue and Epstein Barr. The term Chronic Immune Conditions is defined to include the following diseases, namely Cancer, AIDS/HIV, Hepatitis-C, Herpes, Colds, Influenza, Bronchitis, Chronic fatigue and Epstein Barr. A method and composition for optimizing immune activity, which comprises administering to the mammal a safe and effective daily maximum amount of a mixture of: a) inositol hexaphosphate or a physiologically acceptable salt thereof; b) inositol or a physiologically acceptable salt thereof; c) N-Acetyl Cysteine; d) Alpha Lipoic Acid; and e) a combination of beta-sitosterol and beta-sitosterolin, in the ratio of weight in milligrams of (a):(b):(c):(d), (e) from about 8000 to 10000 milligrams of (a), from about 80 to 250 milligrams of (b), from about 200 to 1500 milligrams of (c), from about 50 to 300 milligrams of (d), and from 5 to 50 milligrams of (e).

Description

A METHOD FOR OPTIMIZING IMMUNE ACTIVITY IN THE TREATMENT OF AUTOIMMUNE DISEASES AND CHRONIC IMMUNE CONDITIONS Known Substance, Novel Therapeutic Application or Method

The invention described herein is directed to a number of different new and useful methods for use with a substance or composition, which are known in the prior art for different uses and or methods of therapeutic application. These new and useful therapeutic applications or methods were previously unknown in the prior art.

A new and useful first method employs a known composition in a new use of that composition for a specified new and therapeutic application of that composition in a method for the treatment of the human body for Hepatitis-C.

Additional claims are appended hereinafter and directed to a substance and or substances known in the prior art for use in this first new and useful method that was previously unknown in the prior art. These additional claims are written as a claim to the use of a known compound for a new particular therapeutic application. These additional claims recite the new technical effects and or features practiced in this first new and useful method, which technical effects or features were previously unknown in the prior art. These technical effects, or features, are described in the detailed description.

NOVEL SUBSTANCE AND NOVEL METHOD The invention is further described herein for a number of different new and useful methods for use with a novel substance(s) or compositions). These new and useful therapeutic applications or methods were previously unknown in the prior art. Both the new and useful compositions) and the new and useful methods were previously unknown in the prior art. A first of these new and useful composition(s) and new and useful therapeutic applications or method(s) unknown in the prior art is also for the treatment of Hepatitis-C in a mammal. Further claims are appended hereinafter and directed to the novel substances or composition for use in a second method unknown in the prior art for the treatment of chronic immune conditions of mammals, including the human body. These further claims are written as purpose-limited product claims. BACKGROUND OF THE INVENTION BACKGROUND EUROPEAN ART (Part 1)

The prior art European Patent EP 422109- A 1 Dr. Abulkalam Shamsuddin teaches a method for moderating the rate of cellular mitosis in a living mammalian tissue having a pathologically elevated rate of cellular mitosis sensitive to treatment with a solution below which comprises perfusing said tissue under mitotic growth conditions with a safe and effective amount and concentration of a composition consisting essentially of a) inositol hexaphosphate or a physiologically acceptable salt thereof, and b) a source of inositol or a physiologically acceptable salt thereof, for a period of time sufficient to moderate the elevated rate of cellular mitosis to a normal, non-pathological rate for said tissue. The prior art further teaches that this method is useful in human and mammalian diseases wherein NK cell activity is altered in the laboratory, e.g. tumors, other cancers including leukemia, immunosuppressed individuals (AIDS) and transplant recipients), and in viral fungal or protozoal infections BACKGROUND UNITED STATES ART (Part 2)

No prior art articles have been found that teaches the use the claimed substance or substances for the treatment of Hepatitis C. There are several publications that teach the use of Inositol as an anticarcinogenic such as "Inositol- A Tumor Growth Inhibitor" by Laszlo, D. and Leuchtenberger, C, Science 97: 515 (1943); and "Studies on Tumor Growth-Inhibitory Substances", by Daniel Laszlo, AAAS Washington, DC, pages 148-156, 1947. There are several publications that teach the use of Phytic Acid or IP6 as an anticarcinogenic such as "Dietary Suppression of Co Ionic Cancer- Fiber of Phytate?", by Graf, E. and Eaton,

J.W., Cancer 56: 717-718, 1985; and "Phytic Acid-A Natural Antioxidant", by Graf, E. Empson, K. and Eaton, J.W., J. Biol. Chem. 1987, Aug 25; 262 (24): 11647-50. In a United States patent to Abulkalam M. Shamsuddin 5, 082,883 there is disclosed a method for moderating the rate of cellular mitosis in a living mammalian tissue having a pathologically elevated rate of cellular mitosis sensitive to treatment with a solution below which comprises perfusing said tissue under mitotic growth conditions with a safe and effective amount and concentration of a composition consisting essentially of a) inositol hexaphosphate or a physiologically acceptable salt thereof, and b) a source of inositol or a physiologically acceptable salt thereof, for a period of time sufficient to moderate the elevated rate of cellular mitosis to a normal, non-pathological rate for said tissue. The method is useful in human and mammalian diseases wherein NK cell activity is altered in the laboratory, e.g. tumors, other cancers including leukemia, immunosuppressed individuals (AIDS and transplant recipients), and in viral, fungal or protozoal infections. DISCUSSION OF THE CLAIMED SUBJECT MATTER One of the features of the present invention is a method for reducing the inflammation and the viral activity in the hepatocytes in living mammals, and for reducing the number of carcinogenic free radicals including hydroxyl and super oxide anions in living mammals, and for enhancing the immune system in HIV/ Aids infected individuals by enhancing the bodily mechanisms including intracellular communication, gene regulation, gene repair and membrane effects. One of the new and novel methods, based on the known composition of inositol hexaphosphate, is for a method for the treatment of Hepatitis-C in a living mammal, and/or for enhancing the immtme system of chronic immune conditions such as the immune system of an HIV infected individual. In this method there is included a new therapeutic application of using the known composition in the treatment of Hepatitis-C in a living mammal. The successful treatment places the Hepatitis C virus in the living mammal into remission. This new and novel therapeutic application has the advantage or technical effect of reducing the inflammation and the viral activity in the hepatocytes in living mammals having an infection of the Hepatitis C virus. This new and novel therapeutic application has the advantage or technical effect or enhancing the immune system or chronic immune conditions such as in an HIV infected individual by enhancing the bodily mechanisms including intracellular communications, gene regulation, gene repair and membrane effects. This method is characterised by administrating to the mammal a safe and effective amount of (a) inositol hexaphosphate or a physiologically acceptable salt thereof in an amount not to exceed 285 mg/kg per day. An additional new and novel method based on the known composition of inositol hexaphosphate and inositol is for a method for the treatment of Hepatitis-C in a living mammal and/or for enhancing the immune system in a living mammal suffering from chronic immune condition such as in an HTV infected individual. In this method there is included a new therapeutic application of using the known composition in the treatment of Hepatitis-C. The successful treatment places the Hepatitis-C virus in the living mammal into remission. This new and novel therapeutic application has the advantage or technical effect of reducing the inflammation of the hepatocytes and the viral activity in a living mammal with an infection of the Hepatitis C virus. This new and novel therapeutic application has the further advantage or technical effect of enhancing the immune system of chronic immune conditions in an HIV infected individual by enhancing the bodily mechanisms including a) intracellular communication, b) gene regulation, c) gene repair, d) membrane effects, and for improving e) the CD4 count in said individual, f) for improving the CD4 to CD8 ratio, g) for reducing the beta 2 microglobulin levels, h) for reducing the CD8 count, and I) for reducing the number of opportunistic infections. This method is characterised by administrating to the mammal a safe and effective amount of (a) inositol hexaphosphate or a physiologically acceptable salt thereof in an amount thereof not to exceed 285mg/kg per day, and (b) inositol or a physiologically acceptable salt thereof in a ratio by weight of (a):(b) from about 4:1 to 1:4.

One of the new and novel methods, based on the new composition of inositol hexaphosphate, N- Acetyl Cysteine and Alpha Lopoic Acid is for a method for the treatment of Hepatitis-C in a living mammal, and/or for enhancing the immune system of chronic immune conditions such as the immune system of an HIV infected individual. In this new and novel method there is included a new therapeutic application of using the known composition in the treatment of Hepatitis-C in a living mammal. The successful treatment places the Hepatitis C virus in the living mammal into remission. This new and novel therapeutic application has the advantage or technical effect of reducing the inflammation and the viral activity in the hepatocytes in living mammals having an infection of the Hepatitis C virus. This new and novel therapeutic application has the advantage or technical effect or enhancing the immune system or chronic immune conditions such as in an HIV infected individual by enhancing the bodily mechanisms including a) intracellular communication, b) gene regulation, c) gene repair, d) membrane effects, and for improving e) the CD4 count in said individual, f) for improving the CD4 to CD8 ratio, g) for reducing the beta 2 microglobulin levels, h) for reducing the CD8 count, and I) for reducing the number of opportunistic infections.. This method is characterised by administrating to the mammal a safe and effective amount of (a) inositol hexaphosphate or a physiologically acceptable salt thereof in an amount not to exceed 285 mg/kg per day. This method is further characterised by administering to the mammal a safe and effective daily maximum amount of a mixture of (a) inositol hexaphosphate or a physiologically acceptable salt thereof, (b) N-Acetyl Cysteine, and (c) Alpha Lipoic Acid, in the ratio of weight in milligrams of (a):(b): (c) from about 8000 to 10000 milligrams of (a) , from about 200 to 1500 milligrams of (b) , and from about 50 to 300 milligrams of (c). A further novel method is for optimizing immune activity in the treatment of chronic immune conditions based on a new composition comprising inositol hexaphosphate, N-Acetyl Cysteine, Alpha Lipoic Acid and phytosterols and sterolins including at least, beta-sitosterol and its glucoside beta-sitosterolin. In this new and novel method using a new composition, there is a new advantage of optimizing immune activity in a living mammal having a chronic immune condition. Two of the chronic immune conditions include, first, a method for the treatment of Hepatitis-C in a living mammal, and/or second, for enhancing the immune system of chronic immune conditions such as the immune system of an HIV infected individual. In this new and novel method there is included a new therapeutic application of using the known composition in the treatment of Hepatitis-C in a living mammal. The successful treatment places the Hepatitis C virus in the living mammal into remission. This new and novel therapeutic application has the advantage or technical effect of reducing the inflammation and the viral activity in the hepatocytes in living mammals having an infection of the Hepatitis C virus. This new and novel therapeutic application has the advantage or technical effect or enhancing the immune system or chronic immune conditions such as in an HTV infected individual by enhancing the bodily mechanisms including a) intracellular communication, b) gene regulation, c) gene repair, d) membrane effects, and for improving e) the CD4 count in said individual, f) for improving the CD4 to CD8 ratio, g) for reducing the beta 2 microglobulin levels, h) for reducing the CD8 count, and I) for reducing the number of opportunistic infections. The term chronic immune conditions is defined to include the following diseases, namely Cancer, AIDS/HIV Hepatitis, Herpes, Colds, Influenza, Bronchitis, Chronic fatigue and Epstein Barr. This method is characterised by administrating to the mammal a safe and effective amount of (a) inositol hexaphosphate or a physiologically acceptable salt thereof in an amount not to exceed 285 mg kg per day. This method is further characterised by administering to the mammal a safe and effective daily maximum amount of a mixture of (a) inositol hexaphosphate or a physiologically acceptable salt thereof, (b) N-Acetyl Cysteine, (c) Alpha Lipoic Acid, and (d) phytosterols and sterolins including at least, beta-sitosterol and its glucoside beta-sitosterolin in the ratio of weight in milligrams of (a):(b): (c): (d) from about 8000 to 10000 milligrams of (a) , from about 200 to 1500 milligrams of (b) , from about 50 to 300 milligrams of (c) ,and from about 5-50 milligrams of (d). CROSS-REFERENCES TO RELATED APPLICATIONS

United States provisional patent application 60/141,437 filed on June 29, 1999, and entitled "Method For Both Reducing The Inflammation In The Hepatocytes And For Reducing The Viral Activity In The Hepatocytes In Living Mammals. A Method For Enhancing The Immune System In HXV Infected Individuals By Enhancing The Bodily Mechanisms Including Intracellular Communication," United States provisional patent application 60/177,387 filed on or about February 1,2000 and entitled "ImmunAlive 3 for the treatment of Hepatitis-C, Cancer, HIV And Other Diseases."

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT Not applicable

REFERENCE TO A "MICROFICHE APPENDIX"

Not applicable

FIELD OF THE INVENTION

The invention relates to a method for both reducing the inflammation in the hepatocytes in living mammals and for reducing the viral activity in the hepatocytes in living mammals. The invention also relates to the treatment of the inflamed hepatocytes in living mammals caused by the Hepatitis-C virus, and relates to the treatment of viral activity in the hepatocytes in living mammals caused by the Hepatitis-C virus. This invention further relates to a composition of inositol (I) and inositol hexaphosphate (JPβ) and their use in reducing such inflammation of the hepatocytes in living mammals, and such use in reducing the viral activity in the hepatocytes of a living mammal. This invention additionally relates to the use with inositol and inositol hexaphosphate of alpha lipoic acid, N- acetyl cysteine, and milk thistle, either alone or in combination, in a method for reducing the inflammation and the viral activity in the hepatocytes in living mammals. This invention relates further to the enhancing of the immune system in HIV infected individuals by improving the immune system by bodily mechanisms including intracellular communications, gene regulation, gene repair, and membrane effects.

BACKGROUND ART

In a patent to Abulkalam M. Shamsuddin 5, 082,883 there is disclosed a method for moderating the rate of cellular mitosis in a living mammalian tissue having a pathologically elevated rate of cellular mitosis sensitive to treatment with a solution below which comprises perfusing said tissue under mitotic growth conditions with a safe and effective amount and concentration of a composition consisting essentially of a) inositol hexaphosphate or a physiologically acceptable salt thereof, and b) a source of inositol or a physiologically acceptable salt thereof, for a period of time sufficient to moderate the elevated rate of cellular mitosis to a normal, non-pathological rate for said tissue. The method is useful in human and mammalian diseases wherein NK cell activity is altered in the laboratory, e.g. tumors, other cancers including leukemia, immunosuppressed individuals (AIDS and transplant recipients), and in viral, fungal or protozoal infections. BRIEF SUMMARY OF THE INVENTION

The present invention provides a method and a composition for reducing the inflammation of the hepatocytes in a living mammaL which comprises administrating to the mammal a safe and effective amount of (a) inositol hexaphosphate or a physiologically acceptable salt thereof in an amount to reduce said inflammation of the hepatocytes in such living mammal. This method and composition includes an alternative combination by combining (a) the IP₆ or its salt, with (b) which is inositol or a physiologically acceptable salt thereof in a ratio of (a): (b) from about 10:1.

The present invention further provides a method and composition for reducing the viral activity in the hepatocytes in a living mammal, which comprises administrating to the mammal a safe and effective amount of (a) inositol hexaphosphate or a physiologically acceptable salt thereof in an amount to reduce said viral activity in the hepatocytes in such living mammal. This method and composition further includes an alternative combination by combining (a) the (IP₆ or its salt), with (b) which is inositol or a physiologically acceptable salt thereof. The present invention still further provides a method and composition for reducing the inflammation and or for reducing the viral activity in the hepatocytes in a living mammal, which comprises administering to the mammal a safe and effective amount of (a) inositol hexaphosphate or a physiologically acceptable salt thereof. This method also includes a first alternative of combining with (a) the IP₆ or it's salt, with (b) inositol or a physiologically acceptable salt thereof in a ratio by weight of (a): (b) from about 10:1. This method and composition includes a second alternative combination by combining (a) and or (b) with one or more of the following, namely: (c) N-Acetyl Cysteine, (d) Alpha Lipoic Acid, and (e) milk thistle.

The present invention provides and method and composition for the treatment of Hepatitis-C in a living mammal by reducing the inflammation of the hepatocytes in such living mammal and by reducing the viral activity in such living mammal.

The present invention is improved by using a moderate amount of either of, or a moderate amount of both, Alpha Lipoic Acid (ALA) and N-Acelyl Cysteine (NAC). Either of the ALA or NAC is added at a level to compliment the recommended dose of inositol hexaphosphate alone or in combination with inositol. The present invention is further improved by the use of additional materials containing natural phytosterols or natural sterolins including beta-sitosterol and its gluoside beta-setosterolin. These materials can be used alone or in combination to enhance the other sustances or combination of substance mentioned above. The present invention is to provide a pharmaceutical composition suitable for use in such a method or methods, preferably adapted for enteral or parenteral administration.

The present invention provides a method and composition for enhancing the immune system of an HIV infected individual by enhancing known bodily mechanisms including intracellular communication, gene regulation,gene repair,membrane effects and by reducing the number of opportunistic infections. SUMMARY OF THE INVENTION

The present invention is usable in the following diseases including Cancer, AIDS/HIV Hepatitis, Herpes, Colds, Influenza, Bronchitis, Chronic fatigue and Epstein Barr. The term Chronic Immune Conditions is defined to include the following diseases, namely Cancer, ATDS/HTV Hepatitis, Herpes, Colds, Influenza, Bronchitis, Chronic fatigue and Epstein Barr.

The pathology of the disease that the invention alters concerns the liver. The liver is infected with a virus. In one infection it is the hepatitis virus. In one of the patients, it is the hepatitis-C virus. The virus enters a cell or cells and lives in the cell until the virus eventually destroys that liver cell. Once a first liver cell has been destroyed the virus then moves on to new liver cell. The virus also reproduces itself. Once reproduced, the new virus infects another healthy cell. This progression increases the number of virus infected cells in the liver. The next step in the progression of the disease is that each virus eventually destroys another healthy cell as it is reproducing and then moving on to continuously infect new healthy cells until the entire liver itself is destroyed. As the individual liver cells are destroyed, the liver develops scar tissue and fatty deposits. The scar tissues and the fatty deposits result in impaired liver function. This impaired liver function is measured by the elevation of the major liver enzymes identified as the Alanine Aminotransferase (ALT) enzyme and the Aspartate Aminotransferase AST) enzyme. The increase of these enzymes is often a result of a liver infection. More specifically, an increase of these enzymes is always the eventual result of the hepatitis-C virus of the liver.

When the measurement or count of these enzymes are elevated to a certain height, it indicates that liver cells are being destroyed. As the liver cells are being destroyed, these enzymes are being released into the blood stream where they can be measured. The enzyme count is one of the most important indications of the health of the liver. The normal numbers for ALT are under 40, and the normal numbers for AST are under 35. The normal numbers for the qualitative PCR test is negative; meaning there's no virus present. A negative qualitative PCR test number means that no virus is detected in the body. It is important to state that since a chronic infection of the hepatitis-C virus produces liver failure 50 percent of the time, reducing enzyme activity and reducing viral load is vital to saving the life of a patient. When the enzymes are kept at a normal level or even slightly elevated level then there is reduced danger or even no danger to the patient. Typically it takes 20 years for Hepatitis C to manifest itself in the patient after exposure. When the viral load isn't eliminated totally, the progress of the disease is slowed down such that it takes much longer for the disease to become fatal to the patient, if at all. This extension of the patients life generally takes the patient to within the patients normal lifetime. Even under this reduced effectiveness the treatment is favorable. Under these circumstances, it is not absolutely necessary that the virus be eliminated. We have seen that when the spread of the virus is slowed down or stopped, the lifetime of the patient is extended significantly. Additionally, the enzyme levels need not be within normal ranges. Rather, the reduction in enzyme levels indicates a reduction in liver damage.

The problem faced by the patient is that once the virus has become activated, and the disease remains untreated, the liver enzymes increase rapidly and there is destruction of the infected liver cells thereafter. The disease continues in 50 percent of the cases until liver scarring and cirrhosis bring about liver failure in the patient. There is not a single rule for the progression of the disease in every patient. The reaction of each patient's body to the infection is different. One such difference is in terms of the rate of spread of the infection of healthy cells after the disease becomes activated. The spread can either be slow or rapid or at any rate in between those limits. The measurement of the viral activity and the measurements of the enzyme levels indicate the speed of the spread of the disease. The advance of the disease also depends on lifestyle of the patient and whether the patient's lifestyle includes the consumption of alcoholic beverages and/or eating fried foods, and or taking medications and drugs that are stressful to the liver.

The general rule is that the immune system of 50 percent of infected patients can destroy the virus after infection. However, the immune systems of the other 50 percent of the people who are infected are unable to cope with the infection. The end result for this 50 percent of the patients is chronic liver disease. The time to liver failure varies with each patient.

Generally, it is not accurate to predict the time to liver failure from the measurement of the viral load by the PCR test. A more accurate prediction of the time to hver failure can be provided from the liver enzyme numbers and hver biopsy. When the hver enzymes are high, in the range of 200- 400, then there is a correlation between these levels of liver enzymes and the amount of damage noted during liver biopsy.

By dropping the patient's liver enzymes level to a point under 50, the damage to the liver would be dramatically reduced in a linear fashion. More specifically, by reducing the ALT enzyme level from 180 to 60 means a two-thirds reduction in the liver damage or destruction. This is a substantial reduction in the Uver damage or destruction. The life expectancy of the patent's liver has been improved considerably.

The entire mechanism of action that causes damage to the liver is not entirely clear at this time.

Therefore, a precise explanation of the very favorable results that I have achieved is not entirely clear. However, I will provide the extent of the results of my studies to date.

BRIEF DESCRIPTION OF THE DRAWINGS

No drawings are used in this application.

BRIEF SUMMARY OF THE TABLES

Table 1 shows the enzyme counts and viral activity levels associated with patient number 1 ; Table 2 shows the enzyme counts and viral activity levels associated with patient number 2;

Table 3 shows the enzyme counts and viral activity levels associated with patient number 3;

Table 4 shows the enzyme counts and viral activity levels associated with patient number 4, and

Table 5 shows the improvement in bodily mechanisms of an HIV patient.

Description of the Preferred Embodiment - Section 1 TABLE 1 HEPATITIS RESEARCH TABLE (1)

Referring Table (1) there is shown the enzyme counts in the form of ALT, AST, and GAMMA GT for patient number 1.

In patient number 1 the treatment began on January 20, 1999, and initial readings were taken as shown in the top row beginning with an ALT reading of 378. In this patient, both the ALT, the AST, and the GAMMA GT readings went up after the approximate first two months of treatment. After an additional two months of treatment, the ALT , the AST and the GAMMA GT levels have all fallen in a direction back towards normalcy and in a positive direction from the start of the treatment.

TABLE 2 HEPATITIS RESEARCH TABLE (2)

Referring to Table (2) there is shown the enzyme counts in the form of ALT, AST and GAMMA

GT for patient number 2.

In patient number 2 the treatment began on February 9, 1999, and the initial readings were taken as shown in the top row beginning with an ALT reading of 96 and an AST reading of 58. In this patient, the ALT, the AST, and the GAMMA GT readings went down after the approximate first two months of treatment.

After an additional one-month of treatment, the ALT, the AST and the GAMMA GT levels have all fallen lower or even reaching normalcy. TABLE 3 HEPATIΗS RESEARCH TABLE (3)

Referring to Table (3) there is shown the enzyme counts in the form of ALT, AST, and GAMMA GT for patient number 3.

In patient number 3 the treatment began on February 26, 1999, and initial readings were taken as shown in the top row beginning with an ALT reading of 182. In this patient both the ALT, and the AST, readings went down after the approximate first three months of treatment.

TABLE 4 HEPATITIS RESEARCH TABLE (4)

Referring to Table (4) there is shown the enzyme counts in the form of ALT, and AST of patient number 4.

In patient number 4 the treatment began on August 8, 1998, and initial readings were taken as shown in the top row beginning with an ALT reading of 331. In this patient both the ALT, and AST, readings went down after over approximate eight months of treatment. I have a similar answer for this patient as for patient number 2 as the reason for the counts decreasing. This patient had undergone treatment for over eight months without having a record made of his or her enzyme and viral load readings. In this time I conclude the enzyme counts had peaked and had retreated below the initial readings.

After an additional two months of treatment, the ALT, and the AST levels have all fallen in a direction back towards normalcy and surely in a positive direction from the start of the treatment.

I have found that my combination of substances in the treatment of Hepatitis-C is very reliable. DETAILED DESCRIPΗON OF THE INVENTION

The interaction of the (a) Inositol Hexaphosphate alone or in combination with and the (b) Inositol with the body for improving the liver function is only partially understood. After viewing the improvement in patients tested alone and with this combination, I conclude that there are many methods with which this combination interacts with the body to improve the health of the Uver. I conclude that inositol hexaphosphate alone or in combination provides an active pharmacokinetic process between the combination selected and the liver cells. From this I conclude that there are many presently unknown methods that the combination of the invention interacts with the liver cells to destroy the invading virus. These substances have already been shown to have antioxidant properties in different environments. The use of Inositol Hexaphosphate alone or in combination with Inositol has never been suggested in the treatment of liver diseases and more particularly in the treatment of Hepatitis-C infection. These antioxidant properties remove free radicals that cause damage within the liver. Cellular damage or inflammations within the Uver are reduced using the antioxidant properties of the combination of substances. Prior to my findings it was unknown whether this mechanism of action is at work in the treatment of Uver infection. As one of its functions, the immune system singles out infected Uver cells and destroys them before the virus infecting that ceU can complete its reproductive phase. The immune system in a healthy body destroys an amount of virus and eventually hopefully eliminates all virus infection. So we know that immune system activity is at work and is enhanced.

Additionally, there are membrane effects in action in the treatment of Uver infection by the combination. There are lipotropic effects in action in the treatment of Uver infection by the combination, as well gene repair effects that the combination has in the treatment of the infection of the liver.

As stated before, the entire mechanism of action that causes damage to the Uver is not entirely clear at this time. Therefore, a precise explanation of the very favorable results that I have achieved is not entirely clear. I conclude that there are an unknown number of other effects in action in the treatment of Uver infection by the combination and I am presently unclear as to the precise identification of these effects. I can state and the tables show that the health of the Uver and the patient greatly improves by taking the combination of substances as I have identified. The progression of the Hepatitis-C infection in the liver is not completely understood. The mechanism of action between the materials of the combination and the disease are also unknown at this time. I suggest that it is just a matter of science progressing before the total mechanism is WO 01/00194 \2₎ PCT/IBOO/00791 known. This is a massive project and not certainly within the capability of just one lab or one team. It requires medical science to move forward and totaUy identify all of the stages of the disease and all of the mechanisms of action between the substances and the infected ceUs. In my experience, the Uver enzymes improve in a rapid fashion. Within a few weeks of taking the prescribed dose, there is an improvement in the liver enzymes. These reductions have never been accomplished in the past.

It is known that the use of the combination of Interferon and Ribavirin, which doesn't work as quickly, is only effective in about 25 percent of the population, and often with very significant side effects. This combination of Interferon and Ribavirin is not as fast acting as the combination of the invention. One hundred percent of my patients are improving with this combination of substances. Treatment has been ongoing for several months. As of this date, no hepatitis-C infected patient has become qualitative PCR negative. Patient's, liver enzymes that were very elevated at the start of treatment showed dramatic improvement, even to the level of becoming normal. But, I have not had any situations where they've gone into a qualitative PCR negative stage where no virus is detected yet.

I have measured liver enzymes being reduced from 450 to 250 in eight weeks. In one case I have had liver enzymes reduced in a linear fashion from a level of 90 to 70 to 50 to 30 in a period of four months. At the beginning of the treatment the enzyme count was 90, and the count remained at this level for two years before treatment with the combination of the present invention was begun. After four months, the enzyme count became normal. These are two different sets of measurements for two different patients. I conclude that this is to be expected for different people. It is important to note that each patient is shown having measurements moving towards normalcy. Prior to my studies, the measurements never improved. The prior art literature shows onward progression of increasing counts of Uver enzymes and or increasing liver scarring and fatty infiltration. The Uver enzyme counts are either stable or increasing which is the same as getting worse. Then the enzyme counts stabilize again before increasing further. In the prior treatment of Hepatitis-C the enzyme counts have not been shown to decrease. In my studies, each patient shows measurements of decreasing enzyme counts. Each patient is improving the health of the Uver. Because the prior art shows no reduction of enzyme counts, the reduction of enzyme counts in even one patient is statistically significant. I conclude that the mechanism of action of my combination of materials that accomplishes the improvement of the liver is different and non-analogous to other claims that have been made for IP₆ These claims are discussed hereinbefore. IPg enhances immune system activity which is certainly a benefit to the Uver. However, my studies have shown that in many cases the Uver enzyme count is reduced. This means that the state of the liver's inflammation and damage is improving.. Also, my studies have shown that the administration of very powerful antioxidants alone to the patient don't reduce the Uver enzyme count. My studies have shown that there is something other than the antioxidant properties of the materials that are the mechanisms in action in these cases. I conclude that there are other mechanisms as yet unknown that cause these liver enzymes to drop. That there are other mechanisms that are unrelated to the lowering of the viral load, and that there are other mechanisms that are unrelated to general antioxidant properties. While the combination has both these properties, the additional unknown properties are also there. I conclude that these unknown properties consistently cause (1) the reduction of liver inflammation. Factor (1) can't be achieved in other methods by just enhancing the immune system or using antioxidants from other sources. So there's something unique but presently unknown about this compound in its steady improvement on aU aspects of the Uver disease. The viral infection of the liver is such a complex subject. The Hepatitis C virus is a retro virus. It is known that rP₆ has effects on the genes, the nucleus, and in the ceU cytoplasm. It is presently unknown whether or not it may block viral reproduction. It is known, that, L β has effects in ceU membranes. It is known that IP₆ has effects in the immune system. IP₆ appears to have effects within and without the cells, microscopically. There are too many effects of IP_ό that have not yet been charted. It is known that the results cannot be accomplished with different compounds each taking a piece of the picture. But, as of yet, it can't be speculated as to everything that D?₆ is capable of doing. It is known that IP₆ is a biochemicaUy natural substance and it forms part of the body's complex mechanisms of gene control and repair, cell repair, prevention of cell damage, intracellular communication, and immune enhancement among possibly many other functions. After understanding these known results, I found a new use for this known compound and I have further improved its function by adding additional substances to this combination.

I concluded that adding (c) Alpha Lipoic Acid and (d) N-Acetyl Cysteine is useful as supportive antioxidants for removing any free radicals from ceU damage, or toxic chemicals in the body. In addition to using substances (a) and (b), I further proposed to use substances (c) and (d) for enhancing the overaU effectiveness of the body's immune system and for assisting the liver to recover. It is the function of the Uver to deal with the toxicity in the body. The Uver is overloaded when it has large amounts of toxicity to flush out of the body. When the liver has less toxicity to process, it is capable of recovering more quickly. I have concluded that the treatment would be more successful by giving extra support to the liver and preventing the Uver from being overloaded from toxic effects of environment, diet, and some metabolism. The supportive role of substances (c) and (d) are to deal with the general toxicity level in the body. As mentioned hereinabove, antioxidants alone are not responsible for reducing the LCT and AST enzyme counts. Alpha Lipoic Acid is considered one of the most powerful known antioxidants. N-Acetyl Cysteine is used by the body to enhance its own production of glutathione peroxidase which is the body's own antioxidant. N-Acetyl Cysteine allows the body to make its own primary antioxidant.

Substance (e) that is useful in my combination is Milk Thistle. Milk Thistle has also been shown to have powerful liver stabilizing effects in people infected with the hepatitis virus. Milk Thistle alone has achieved neither reductions in viral load nor reductions in enzyme counts. Milk Thistle has been the best natural substance studied medically. In virtuaUy all the tests conducted with Milk Thistle, it has shown some Uver function improvement.

In the combination of the product Umited to just Uver appUcations, (e) milk thistle is a positive added ingredient. The addition of Milk Thistle is irrelevant in the treatment for any other disease process.

The compounds of this invention can be employed admixture with conventional excipients, i.e., pharmaceutically acceptable organic or inorganic carrier substances suitable for parenteral, enteral (e.g., oral) or topical application which do not deleteriously react with the pharmacologically active compounds. Suitable pharmaceuticaUy acceptable carriers include but are not limited to water, salt solutions, alcohols, gum Arabic, vegetable oils, benzyl alcohols, polyethylene glycols, gelatin, carbohydrates such as lactose, amylase or starch magnesium stearate, talc, silicic acid, viscous paraffin, perfume oil, fatty acid monoglycerides and diglycerides, pentaerythritol fatty acid esters, hydroxymethyl cellulose, polyvinyl pyrroidone, etc. The pharmaceutical preparations can be sterilized and if desired mixed with auxiUary agents, e.g., lubricants, preservatives, stabilizers, wetting agents, emulsifiers, salts for influencing osmotic pressure, buffers, coloring, flavoring and/or aromatic substances and the like which do not deleteriously react with the active compounds. They can also be combined where desired with other active agents, e.g., vitamins, antioxidants including vitamin C, proanthocyanidins, carotenids, polyphenol complex, lycopene, and CoQIO, among other active antioxidants. For parental application, particularly suitable are injectable, sterile solutions, preferably oily or aqueous solutions, as weU as suspensions, emulsions, or implants, including suppositories. Ampoules are convenient unit dosages.

For enteral application, particularly suitable are tablets, dragees, liquids, drops, suppositories, or capsules. A syrup, elixir, or the like can be used. Sustained or directed release compositions can be formulated, e.g., Uposomes or those wherein the active compound is protect with differentially degradable coatings, e.g. by micro- WO 01/00194 ifø PCT/TB00/00791 encapsulation, multiple coatings, etc. It is also possible to freeze-dry the compounds and use the lypholizates obtained, for example, for the preparation of products for injection. For topical appUcation, non-sprayable viscous to semisoUd or soUd non-sprayable forms comprise a carrier compatible with topical application and having a dynamic viscosity preferably greater than water. Suitable formulations include but are not Umited to solutions, suspensions, emulsions, creams, ointments, powders, liniments, salves, aerosols, etc. which are, if desired, sterilized or mixed with auxiliary agents, e.g. preservatives, stabilizers, wetting agents, buffers, salts for influencing osmotic pressure, etc. Also suitable for topical application are sprayable aerosol preparations wherein the active ingredient, preferably in combination with a soUd or liquid inert carrier material, is packaged in a squeeze bottle or in admixture with a pressurized, volatile, normaUy gaseous propeUant, e.g., a freon.

Oral administration is presently preferred although, depending on the location and nature of the tissue being treated, other known types of administration can be preferred, e.g. Generally, the compounds of this invention are dispensed in unit dosage form comprising about 0.1 to 10 g. in a pharmaceutically acceptable carrier per unit dosage. They are incorporated in topical formulations in concentrations of about 1 to 10 percent by weight. It will be appreciated that the actual preferred amounts of active compound in a specific case wUl vary according to the specific compound ratios being utilized, the particular compositions formulated the mode of appUcation, and the particular situs and organism being treated. Dosages for a given host can be determined using conventional considerations, e.g. by comparison of the differential activities of the pharmaceuticaUy active compounds of this invention with known agents by means of an appropriate conventional pharmacological protocol and extrapolation of the dosages based on the results thereof, as is know in the art. The preferred method of deUvery is just through the oral route. The substance is soluble in water and so it can be fed through a drink. Inositol Hexaphosphate is a natural agent. It is known that π\s is attracted to minerals and binds with such minerals. If IPβ is taken with food, then it will bind to the minerals in the food and the effectiveness of the IPβ will be reduced. The preferred process for taking the combination of the present invention is to take on an empty stomach or to take it with food that doesn't have a significant mineral content. The combination of substances of the present invention is the same for treating all animals. Putting the combination into their water supply can treat animals. This is the preferred method of delivery for deUvering the combination to large populations in rural or underprivileged areas. It could be mixed into drinking water or it could be mixed in the food supply. Just by their daily diet, individuals would have a benefit to their immune system. EventuaUy, this improvement in immune system improves the quality and length of life for the individuals consuming the combination of the present invention. When mixed in food, the composition of the food is not important, as long as the dosage is increased to compensate for some loss of effectiveness. I am proposing to use IP₆ as a treatment and adding it to the body because IP₆ is found in every ceU of the body. IP₆ is a naturally occurring compound in foods and IP₆ is a naturally occurring compound within the body. IP₆ has so many functions within the body, that the supply of IP₆ available to the body for curative functions becomes used up in accomplishing this role. D?6 is not an enzyme, and it can become depleted. As an active substance, it is used up in its role of gene protection, ceU protection, and antioxidant function. I propose to keep the level of IP₆ at maximum possible level. At this level, IP₆ is capable of improving the body's health by many pharmacokinetic pathways. I propose that a patient take IPβ continuaUy. In this manner, the patient keeps the Inositol-Inositol hexaphosphate pathway at maximum activity and effectiveness. π ₆ is converted by the body into aU the other forms of Inositol Phosphates including Inositol Diphosphate, Triphosphate, Inositol and Phosphatidyl Inositol. The body also breaks down Inositol Hexaphosphate into Inositol. There is an interchange between aU the different forms of Inositol in the body as well as Inositol levels being resupplied by incoming food Inositol. By using substance (a) Inositol Hexaphosphate, in my combination, the combination provides the most direct and most powerful substance to enhance the body's immune levels. The addition of substance (b) Inositol provides additional curative material for the body's use. I have concluded that the use of Inositol alone, is not the preferred form of treatment. The formulation of the combination and the amount of the substances that are claimed have been found and proposed to be suitable. I have found in the diseases that I treat that Inositol Hexaphosphate is the active substance going directly to improve liver functions that need improvement. The body is provided with enough of the starting material Inositol and enough of the final product Inositol Hexaphosphate to convert these materials into aU the various forms of Inositol that are needed in the biochemical intermediates. The body is not running out of any of the materials. This procedure within the body of converting the starting materials to intermediate materials and thence to final materials is not rate limited. Rate limiting is defined as limiting the rate of effectiveness of the intermediate and final substances by lack of supply of the building blocks of these final substances. The amount of combination of substances taken by the patient is to provide a suitable supply of the needed materials to the body so that the body can use such materials for aU of the purposes that it needs. The formulation of the combination and the amount of the substances that are claimed have been found and proposed to be the most suitable. One advantage of working with these natural occurring biochemical substances is that the body has its own built-in regulatory process for working with these naturaUy occurring biochemical substances. The body can absorb the substances selectively. The body can metabolize the substances. The body is not being overloaded. The body has the mechanisms for using what it needs and getting rid of what it doesn't need. I propose to keep the suppUes of the inventive substances at a maximum level to the body. Here, by supplying the body with as much of the inventive substance as you need or a slightly elevated level above maximum, the body just eUminates what it doesn't need. The inventive substances are water-soluble. The body wUl urinate unneeded substances out so that the body is not stressed by supplying the maximum amount of the combination. As a result of my treatments I proposed that using a moderate amount of either of, or a moderate amount of both, Alpha Lipoic Acid (ALA) and N-Acetyl Cysteine (NAC) is the proper procedure for enhancing the effectiveness of my combination of substances. The maximum doses of ALA for appUcation to the body have been well established. Because ALA is not a naturally occurring compound in the body, I would not propose to give an ongoing ever- increasing amount of this substance. I propose to add the ALA at a level that compliments my recommended dose of Inositol Hexaphosphate alone or the combination of Inositol hexaphosphate and Inositol. Under this arrangement, the patient is receiving the correct dose of Alpha Lipoic Acid and N-Acetyl Cysteine.

One of the differences of action for IPβ for hepatitis and for HIV, versus cancer is in the mechanism of regulating uncontroUed mitosis, which is not relevant in the diseases of Hepatitis and HIV. The immune enhancing effect of IP₆ is not relevant for stopping uncontrolled cellular mitosis, but it's more relevant for treating HIV and Hepatitis. I propose that there are other genetic impacts that IP₆ has.

I further propose that my success with inositol hexaphosphate alone or with additional materials containing natural phytosterols or natural sterolins including beta-sitosterol and its glucoside beta-sitosteroUn, my combination is enhanced. These materials are processed by the body beginning in the natural form of sprouts or oils. These sprouts or oils are taken in greater amounts. For example, 300 to 400 milUgrams of the following sprouts are processed to provide about 10 milligrams of active ingredients. The sprouts are Usted first followed by the active molecules that I have identified as effective. The sprouts include oilseed plant sprouts, wild african potato sprouts, lupins sprouts, fenugreek sprouts, wild barley sprouts, wheat sprouts, soybean sprouts, african sunflower sprouts. From these spouts, the body processes the foUowing molecules including, Beta-Sitosterol, Beta-Sitosterolin, Campesterol, Campesterolin, Brassicasterol, Brassicasterolin, StigmasteroL, Stigmasterolin, Ergosterol, ErgosteroUn, Avenasterol and AvenasteroUn. The Beta-Sitosterol and the Beta-Sitosterolin comprise 90% of the molecules processed by the body. Each of the other ingredients comprise about 1% of the mixture of molecules.

My treatments have clearly shown that other immune enhancing abilities of rP₆ exists beyond its ability for enhancing the production of natural kUler cells. As previously stated these other immune enhancing abilities are as of yet unknown.

HIV RESEARCH GRAPH

IP₆ is beneficial for treatment of HIV. In it's treatment of HIV, IP₆ has consistently increased the CD4 count. In it's treatment of HIV, IP₆ has consistently reduced the beta 2 microglobulin levels back to normal. In it's treatment of HIV, IP₆ has consistently improved the CD4 to CD8 ratio. In it's treatment of HIV, IP₆ has reduced the number of opportunistic infections, which is also the result of an improved immune system. While granting that JPβ helps to restore depressed natural killer cell function, the overall immune system is enhanced by IP₆ in a dramatic way. It is completely unknown whether there are other mechanisms at change in operation. IP₆ and Inositol in combination do combine to make IP₃ molecules which are extremely important chemical messengers and participate in the mechanism of genetic regulation of the cells.

ADDITION OF BETA-SITOSTEROL AND BETA-SITOSTEROLIN

This portion of the detailed description of the present invention is directed to the explanation of the benefits attributed to each of the novel components used in the present invention. In this section, each of the components of the present invention are defined to refer to their constituent parts for brevity.

Component 1 is inositol hexaphosphate.

Component 2 include Alpha Lopoic Acid, and N-Acetyl Cysteine in combination alone.

Combination 2 can be used alone or in further combination with inositol. The benefits of inositol are attributed to inositol. Component 3 refers to the following molecules including, Beta-Sitosterol, Beta-Sitosterolin, Campesterol, CampesteroUn, Brassicasterol, BrassicasteroUn, Stigmasterol, Stigmasterolin, Ergosterol, ErgosteroUn, Avenasterol and AvenasteroUn.

Component 3 function synergistically in conjunction with components 1 + 2 to optimize immune activity in the treatment of chronic immune conditions.

The present invention includes component 3 working both (1) alone and (2) synergistically with components 1 + 2.

The detailed technical features and mode of operation of components 1 and 2 are described in detail with reference to Section 1 which is also found in the United States provisional patent application 60/141,437, filed on June 29, 1999.

This synergistic operation of components 1,2 and 3 maximizes immune activity in an unprecedented way for the treatment of Hepatitis C, HIV, Cancer and other serious immune conditions. The detailed technical features and mode of operation of component 3 working alone and in synergistic manner with components 1 and 2 are described in detail in United States provisional patent appUcation 60/177,387, filed on Feb. 2, 2000.

The advantages added to the overall immune system by the use of the third major component of this patented composition and the novel method for using this composition in a new therapeutic appUcation are described in this Section.2.

Component 3 comprises ten (10) miUigrams of active ingredients comprising principally the following, namely:

1) Phytosterols and sterolins; and

2) Beta-sitosterol and its glucoside beta-sitosteroUn.

Component 3 is provided in its natural and non-toxic state in the form of 350 milligrams in sprout form. One suitable source of this ten miUigram of active molecules is selected from the foUowing products, namely; (1) oilseed plant sprouts, (2) wild African potato sprout, (3) lupins sprouts, (4) fenugreek sprouts, (5) wild barley sprouts, (6) wheat sprouts, (7) soybean sprouts (8) African sunflower sprouts. The ten- (10) milUgrams of phytosterols and sterolins including beta- sitosterol and its glucoside, beta-setosterolin, are reconstructed by the human body from these natural ingredients when consumed by the body into the active ingredients. The active ingredients are the source of the molecules identified above.

Independent of components 1 and 2, the active molecular ingredients of component 3 are used by the immune system to optimize immune activity by increasing immune activity. The ingredients of component 3 have the abUity to optimize the body's immune activity by stimulating the body's immune system into providing the foUowing technical features 1 through 11, not previously made available to the pubUc, namely;

I) Enhancing T-cell proUferation, including enhanced T-ceU replication, discussed in 3, immediately below provides a first fundamental improvement; 2) Promoting the secretion of cytokines interleukin-2 and gamma- interferon provides a second fundamental improvement;

3) Enhancing T-ceU replication and or growth;

4) Balancing both the antibody and ceUular immune responses;

5) Supporting the immune system to become fully operational as a whole: 6) Inhibiting the damaging effects of antibodies, in the case of auto-immune conditions, that are pathologically attacking the body's own tissues, once the balance identified in feature 4 is achieved;

7) Working to provide its beneficial technical features without harmful side effects;

8) Counteracting the inflammatory response associated with immune activity; 9) Preventing the destruction of tissues and organs from inflammation;

10) Regulating immune activity both inside and outside the cells; and

I I) Reducing the inflammation to the immune battle including the inflammation that results from NK cell activity.

Feature number 1 is a fundamental and important feature and advantage because the T-ceUs are the "generals" of the immune system that coordinate the overall immune attack. This feature is of particular importance in treating chronic immune diseases such as HIV. The increased secretion of cytokines interleukin 2 and gamma-interferon, identified in Feature number 2, helps regulate appropriate antibody activity. Again, this feature is of particular importance in autoimmune illnesses. As mentioned in feature number 3 above, no other combination has been found that safely enhances T-cell repUcation and growth. This feature is of particular importance in treating chronic immune diseases such as HTV.

Feature number 4 of component 3, helps to balance cellular immune activity with antibody immune activity in order to improve overaU immune response. This feature is of particular importance with the foUowing illnesses, namely: Autoimmune, cancer, HTV and Hepatitis-C. Feature number 8 is particularly important in the fight against Hepatitis C, in which inflammation of the Uver can result in the destruction of the organ itself. In the case of HIV, the immune system is progressively destroyed because the T-ceUs are killed which then leaves the immune system dysfunctional In the case of cancer, the cancer grows faster than the immune system can cope with or the immune system doesn't recognize the cancer deUs and thus does not mount an effective attack against the cancer.

THE IMMUNE SYSTEM CHALLENGE OF SEVERE IMMUNE CONDITIONS The particular problem with chronic immune disease is that the immune system becomes worn down and or less active over time. When an immune system becomes less active, the following activity is reduced, namely:

1) In the case of Hepatitis C, for instance, a person's immune system may be fighting the disease for 20 years before symptoms develop. This means the foUowing, namely: a) the nutrients that supply the immune system are gradually diminished: b) the person's natural resistance is diminished; c) There is a production of powerful chemicals by the body during immune battles: d) Inflammation and ceUular damage are caused during the vicious immune battles by the newly created powerful chemicals identified in c above; e) When inflammation and cellular damage are unchecked, the body becomes overstressed: f) The immune system can begin to destroy itself when the body loses vital function. This self-destruction of the immune system is also known as a case of auto immune. This is a dangerous situation and can potentially occur in cases of Hepatitis-C and AIDS. No discovery to date in the medical world has been able to improve overall immune activity. Conventional treatments, such as the use of interferon or interleukin, have resulted in the improvement of one part of the immune response but at the expense of another immune response. Certain drugs, for instance, to counteract auto-immune disease have focussed on inhibiting the entire immune response, but have left the body open to opportunistic secondary infections. Many conventional approaches also yield dangerous side effects. A few conventional treatments have been found to improve the activity of natural killer cells, but none also address the problem addressed by the ingredients of the present invention which address the following technical problems, namely:

1) Handling inflammatory issues;

2) Enhancing T-ceU activity; and or

3) Regulating antibodies.

The underlying problem is that the immune system is vastly complex and depends upon a high degree of synergism between its various components. Any attempt to improve immune function that does not take into consideration the entire system cannot hope to provide a lasting solution to immune devastating disorders.

THE PRESENT INVENTION'S COMPREHENSIVE APPROACH TO IMMUNE ENHANCEMENT All three components of the present invention are used in a novel manner to support the overall immune system by affecting the before identified technical features 1-11, amongst others Usted below. By approaching immune support from several angles simultaneously, the individual benefits of components 1,2 and 3 operate synergisticaUy to promote and support the activity of the entire immune system and its interrelated components. The immune system's first line of defense against harmful agents, including viruses, cancer cells and parasites, are the natural killer ceUs (NK cells.) These cells are designed to act on their own initiative to deal with invaders. Although essential, the scope of the NK cells work is Umited. The second line of defense involves a team of white blood cells (including macrophages, monocytes, neutrophils and lymphocytes), B-cells and anti-bodies. These immune components are controUed by T-cells which act as generals controlling and directing an entire army of immune factors. Each component of the immune system relies upon the others to do their job properly.

Often, however, particularly in response to chronic immune conditions, immune activity can become compromised. Due to this compromise of immune activity, the host human body faces new problems not previously treatable except by the new use of substances or compositions of the present invention. Some of the reasons for compromising immune activity include the foUowing, namely:

1) Certain infectious agents responsible for auto-immune conditions confuse the immune system and cause antibodies to go out of control and begin to attack healthy cells.

2) As a result of immune warfare, ceUular debris and free radicals builds up within the body. Such toxic elements impede immune activity and can even damage the ceUs' genetic material.

3) The antibody immune response exceeds the cellular immune response resulting in immune imbalance that leads to tissue inflammation and impaired immune activity. SYNERGY BETWEEN THE COMPONENTS

Each of the components 1,2 and 3 support one another's activities synergistically to create immune balance and raise overaU immune response. Component 1 consists of inositol hexaphosphate. Inositol hexaphosphate has been identified as improving the foUowing technical features of immune activity, namely:

1 ) Enhancing the activity of NK ceUs to reduce viral load;

2) Preventing genetic damages within the cells; 3) Blocking the formation of cancer ce Us;

4) Providing the groundwork for the immune activities promoted by component 3; and

5) Reducing and or eliminating oxidative damage caused at least by super oxide molecules and or free radicals.

Component 2 is inositol and inositol is a antioxidant. Inositol has been identified as improving the following technical features of immune activity, namely:

1) Clearing the free radicals caused by ceUular damage;

2) Removing toxic load and free radicals that are present as a result of the immune responses promoted by components 1 and 3;

3) Enhancing the activity of inositol hexaphosphate in component 1 for helping to protect the ceUs' genetic material from oxidative damage; and

4) Elevating interceUular levels of glutathione and glutathione peroxidase.

In combination, components 1 and 2 have been identified as improving the following technical features of immune activity, namely:

1) Regulating and or re-regulating any un-regulated genes; and 2) Preventing the formation of destructive ceUs and/or cancerous cells.

3) The alpha lipoic acid, found in component 2 has been identified as improving the following technical features of immune activity, namely:

1) Reducing oxidative stress to the ceUs.

2) Such oxidative stress when left unchecked can have a powerfully detrimental impact on immunity.

Component 2 has been identified to work efficiently in combination with components 1 and 3 in improving the foUowing technical features of immune activity, namely:

1) Removing free radicals that would otherwise impair the activities promoted by each of the components 1 and 2; and 2) 2) By working synergistically with component 1 by increasing natural killer cell activity. Component 3 has been identified as improving the foUowing technical features of immune activity, namely:

1) Enhancing the balance of both the antibody and ceUular immune responses; and, 2) Supporting the immune system to become fuUy operational as a whole. Component 3 has been identified as working in combination with Component 1 in improving the foUowing technical features of immune activity, namely: a) Encouraging the T-ceUs to produce more interferon, which in turn helps the work of component 1 by enhancing the effectiveness of the NK cells; and b) Encouraging the growth of new T-ceUs and the production of antibodies At the first sign of infection, NK cells go to work immediately to fight the invaders. As the first line of defense, NK cells allow the body to ^*buy time' while the second line of defense, supported by component 3, activates a second technical feature of T-ceU growth: Component 1 helps the NK cells to reduce viral load, and therefore gives the T-ceUs, stimulated by component 3, the opportunity to grow and reproduce. The T-ceUs in turn bring the entire immune response into balance, optimizing its defenses.

As previously described, component 3 also reduces the inflammatory response to the immune battle, including the inflammation that results from NK cell activity. This prevents the destruction of tissues and organs (especially relevant in the treatment of Hepatitis C.

As each component 1,2 and 3 of the present invention functions to provide its individual advantages and new technical effects, as identified hereinabove, each of the three major components enhances and or cooperates with each of the other components, for that component to contribute the factors and advantages identified as coming from that component. In some respect, it is believed that some components are working synergisticaUy with others of the components. However, much additional research is needed to firmly identify this synergistic effect. The ingredients of the three components 1,2 and 3 help reduce overaU immune stress in the immune system and promote optimal immune activity. In this way the immune system is able to both (1) counter an attack and at the same time (2) rebuUd itself in order to effectively (a) combat disease and (b) control auto immune conditions even over extended periods of time. For an average 70-80kg person, the ideal quantity of plant sterols and sterolins to consume is lOmg per day. This means taking approximately 350mg of the sprout concentrate source of beta- sitosterols and sterolins. This weight of sprout concentrate yields the lOmg, together with the various micro-molecules, describe above that promote their effectiveness. PARAMETERS FOR MEASURING IMMUNE SYSTEM IMPROVEMENT WITH THE USE OF COMPONENTS 1, 2, AND 3

There are several markers or advantages for measuring immune system improvement with the use of the present invention. There are various markers for success in the treatment of diseases, depending on the condition being treated. In the case of Hepatitis C, results or advantages are seen as a reduction in Uver enzymes and through biopsy exarnination of the Uver ceUs. In the WO 01/00194 Q f PCT/IBOO/00791 case of HIV, the markers or advantages are measured by measurement of several immune parameters such as CD4 counts, CD4/CD8 ratios, Beta-2 microglobulin levels and percentage of CD4 lymphocytes. Where cancer is concerned, the markers or advantages are measured by measurement of blood content as seen in blood tests, tumor markers, CAT scans and MRI's for tumor size. For breast cancer the relevant marker is CA15-3, for ovarian cancer CA125, pancreatic cancer CA19-9, colon cancer CEA.

The present invention includes many aspects for improving mammalian health including at least but not limited to the following such as a method and composition for optimizing immune activity in the treatment of chronic immune conditions wherein the chronic immune conditions is Hepatitis-C.

A method and composition is described for reducing the inflammation and the viral activity in the hepatocytes in living mammals, and for reducing the number of carcinogenic free radicals including hydroxyl and super oxide anions in living mammals, and for enhancing the immune system in HTV/ Aids infected individuals by enhancing the bodUy mechanisms including intracellular communication, gene regulation, gene repair and membrane effects.

A method and composition for optimizing immune activity under conditions of chronic immune conditions in the treatment of such chronic immune conditions wherein the chronic immune conditions include Hepatitis-C, Cancer, AIDS/HIV , Herpes, Colds, Influenza, Bronchitis, Chronic fatigue and Epstein Barr. The term Chronic Immune Conditions is defined to include the foUowing diseases, namely Cancer, AIDS/HIV Hepatitis-C, Herpes, Colds, Influenza, Bronchitis, Chronic fatigue and Epstein Barr.

A method and composition for optimizing immune activity under conditions of chronic immune conditions in the treatment of such chronic immune conditions wherein the chronic immune conditions include Hepatitis-C, Cancer, AIDS/HTV, Herpes, Colds, Influenza, Bronchitis, Chronic fatigue and Epstein Barr, which comprises administering to the mammal a safe and effective daily maximum amount of a mixture of (a) inositol hexaphosphate or a physiologically acceptable salt thereof, (b) inositol or a physiologically acceptable salt thereof, (c) N-Acetyl Cysteine, (d) Alpha Lipoic Acid, and (e) a combination of beta-sitosterol and beta-sitosteroUn, in the ratio of weight in milligrams of (a):(b): (c): (d), (e) from about 8000 to 10000 milligrams of (a) , from about 80 to 250 milligrams of (b) , from about 200 to 1500 milligrams of (c) , from about 50 to 300 miUigrams of (d), and from 5 to 50 milligrams of (e).

A method and composition for optimizing immune activity in the treatment of chronic immune conditions wherein the chronic immune conditions is Hepatitis-C. WO 01/00194 fl PCT IBOO/00791

A method and composition for optimizing immune activity under conditions of chronic immune conditions in the treatment of such chronic immune conditions wherein the chronic immune conditions include Hepatitis-C, Cancer, AIDS/HIV , Herpes, Colds, Influenza, Bronchitis, Chronic fatigue and Epstein Barr. A method and composition for reducing the inflammation of the hepatocytes in a Uving mammal and for reducing the viral activity in the hepatocytes in a Uving mammal, which comprises administering to the mammal a safe and effective amount of (a) inositol hexaphosphate or a physiologically acceptable salt thereof, and (b) inositol or a physiologically acceptable salt thereof in a ratio by weight of (a): (b) from about 4:1 to 1:4. This method and composition includes an enhanced and improved alternative combination by combining (a) and (b) with one or more of (c) N-Acetyl Cysteine,and (d) Alpha Lipoic Acid, and (e) Milk Thistle for treatment of selective pre-cancerous cells generated by the body. This method and composition includes an enhanced and alternative combination by combining (a) and (b) with one or more of (c) and (d) and (e) and or with additional materials containing natural phytosterols or natural sterolins including beta-sitosterol and its glucoside beta-sitosterolin for placing human Hepatitis-C into remission, and for treatment of selective precancerous cells generated by the body. This method also includes features for enhancing the immune system in an HIV infected individual through bodily mechanisms including intraceUular communication, gene regulation, gene repair, and membrane effects and for reducing the number of opportunistic infections in said infected individual.

A method and composition for reducing the inflammation of the hepatocytes in a Uving mammal and for reducing the viral activity in the hepatocytes in a living mammal, which comprises administering to the mammal a safe and effective amount of (a) inositol hexaphosphate or a physiologically acceptable salt thereof, and (b) inositol or a physiologically acceptable salt thereof in a ratio by weight of (a): (b) from about 10:1. This method and composition includes an enhanced and improved alternative combination by combining (a) and (b) with one or more of (c) N-Acetyl Cysteine,and (d) Alpha Lipoic Acid, and (e) Milk Thistle for treatment of selective pre-cancerous ceUs generated by the body. This method and composition includes an enhanced and alternative combination by combining (a) and (b) with one or more of (c) and (d) and (e) and or with additional materials containing natural phytosterols or natural sterolins including beta-sitosterol and its glucoside beta- sitosterolin for placing human Hepatitis-C into remission, and for treatment of selective precancerous ceUs generated by the body. WO 01/00194 g PCT/IBOO/00791

One of the additional features of the present invention is a method for reducing the inflammation and the viral activity in the hepatocytes in Uving mammals, and for reducing the number of carcinogenic free radicals including hydroxyl and super oxide anions in living mammals, and for enhancing the immune system in HIV/ Aids infected individuals by enhancing the bodily mechanisms including intracellular communication, gene regulation, gene repair and membrane effects.

One of the new and novel methods, based on the known composition of inositol hexaphosphate, is for a method for the treatment of Hepatitis-C in a living mammal, and/or for enhancing the immune system of chronic immune conditions such as the immune system of an HIV infected individual. In this method there is included a new therapeutic application of using the known composition in the treatment of Hepatitis-C in a Uving mammal. The successful treatment places the Hepatitis C virus in the living mammal into remission. This new and novel therapeutic application has the advantage or technical effect of reducing the inflammation and the viral activity in the hepatocytes in living mammals having an infection of the Hepatitis C virus. This new and novel therapeutic application has the advantage or technical effect or enhancing the immune system or chronic immune conditions such as in an HTV infected individual by enhancing the bodily mechanisms including intracellular communications, gene regulation, gene repair and membrane effects. This method is characterised by administrating to the mammal a safe and effective amount of (a) inositol hexaphosphate or a physiologically acceptable salt thereof in an amount not to exceed 285 mg/kg per day.

An additional new and novel method based on the known composition of inositol hexaphosphate and inositol is for a method for the treatment of Hepatitis-C in a living mammal and/or for enhancing the immune system in a Uving mammal suffering from chronic immune condition such as in an HIV infected individual. In this method there is included a new therapeutic appUcation of using the known composition in the treatment of Hepatitis-C. The successful treatment places the Hepatitis-C virus in the Uving mammal into remission. This new and novel therapeutic application has the advantage or technical effect of reducing the inflammation of the hepatocytes and the viral activity in a living mammal with an infection of the Hepatitis C virus. This new and novel therapeutic application has the further advantage or technical effect of enhancing the immune system of chronic immune conditions in an HIV infected individual by enhancing the bodily mechanisms including a) intraceUular communication, b) gene regulation, c) gene repair, d) membrane effects, and for improving e) the CD4 count in said individual, f) for improving the CD4 to CD8 ratio, g) for reducing the beta 2 microglobulin levels, h) for reducing the CD8 count, and I) for reducing the number of opportunistic infections. This method is characterised by administrating to the mammal a safe and effective amount of (a) inositol WO 01/00194 g PCT/IBOO/00791 hexaphosphate or a physiologically acceptable salt thereof in an amount thereof not to exceed 285mg/kg per day, and (b) inositol or a physiologically acceptable salt thereof in a ratio by weight of (a):(b) from about 10:1.

One of the new and novel methods, based on the new composition of inositol hexaphosphate, N- Acetyl Cysteine and Alpha Lopoic Acid is for a method for the treatment of Hepatitis-C in a living mammal, and/or for enhancing the immune system of chronic immune conditions such as the immune system of an HTV infected individual. In this new and novel method there is included a new therapeutic application of using the known composition in the treatment of Hepatitis-C in a Uving mammal. The successful treatment places the Hepatitis C virus in the living mammal into remission. This new and novel therapeutic appUcation has the advantage or technical effect of reducing the inflammation and the viral activity in the hepatocytes in Uving mammals having an infection of the Hepatitis C virus. This new and novel therapeutic application has the advantage or technical effect or enhancing the immune system or chronic immune conditions such as in an HTV infected individual by enhancing the bodily mechanisms including a) intraceUular communication, b) gene regulation, c) gene repair, d) membrane effects, and for improving e) the CD4 count in said individual, f) for improving the CD4 to CD8 ratio, g) for reducing the beta 2 microglobulin levels, h) for reducing the CD8 count, and I) for reducing the number of opportunistic infections.. This method is characterised by administrating to the mammal a safe and effective amount of (a) inositol hexaphosphate or a physiologically acceptable salt thereof in an amount not to exceed 285 mg/kg per day. This method is further characterised by administering to the mammal a safe and effective daUy maximum amount of a mixture of (a) inositol hexaphosphate or a physiologically acceptable salt thereof, (b) N-Acetyl Cysteine, and (c) Alpha Lipoic Acid, in the ratio of weight in milUgrams of (a):(b): (c) from about 8000 to 10000 milligrams of (a) , from about 200 to 1500 milligrams of (b) , and from about 50 to 300 miUigrams of (c).

A further novel method is for optimizing immune activity in the treatment of chronic immune conditions based on a new composition comprising inositol hexaphosphate, N-Acetyl Cysteine, Alpha Lipoic Acid and phytosterols and sterolins including at least, beta-sitosterol and its glucoside beta-sitosterolin. In this new and novel method using a new composition, there is a new advantage of optimizing immune activity in a living mammal having a chronic immune condition. Two of the chronic immune conditions include, first, a method for the treatment of Hepatitis-C in a Uving mammal, and/or second, for enhancing the immune system of chronic immune conditions such as the immune system of an HIV infected individual. In this new and novel method there is included a new therapeutic application of using the known composition in the treatment of Hepatitis-C in a Uving mammal. The successful treatment places the Hepatitis C virus in the living mammal into remission. This new and novel therapeutic application has the advantage or technical effect of reducing the inflammation and the viral activity in the hepatocytes in living mammals having an infection of the Hepatitis C virus. This new and novel therapeutic application has the advantage or technical effect or enhancing the immune system or chronic immune conditions such as in an HIV infected individual by enhancing the bodily mechanisms including a) intraceUular communication, b) gene regulation, c) gene repair, d) membrane effects, and for improving e) the CD4 count in said individual, f) for improving the CD4 to CD8 ratio, g) for reducing the beta 2 microglobulin levels, h) for reducing the CD8 count, and I) for reducing the number of opportunistic infections. The term chronic immune conditions is defined to include the foUowing diseases, namely Cancer, AIDS HTV Hepatitis, Herpes, Colds, Influenza, Bronchitis, Chronic fatigue and Epstein Barr. This method is characterised by administrating to the mammal a safe and effective amount of (a) inositol hexaphosphate or a physiologically acceptable salt thereof in an amount not to exceed 285 mg/kg per day. This method is further characterised by administering to the mammal a safe and effective daUy maximum amount of a mixture of (a) inositol hexaphosphate or a physiologically acceptable salt thereof, (b) N-Acetyl Cysteine, (c) Alpha Lipoic Acid, and (d) phytosterols and sterolins including at least, beta-sitosterol and its glucoside beta-sitosterolin in the ratio of weight in miUigrams of (a):(b): (c): (d) from about 8000 to 10000 milligrams of (a) , from about 200 to 1500 milligrams of (b) , from about 50 to 300 miUigrams of (c) ,and from about 5-50 miUigrams of (d).

Although the invention has been described in detail with reference to its originaUy preferred embodiment it wiU be understood by one of ordinary skill in the art that various modifications can be made without departing from the spirit and scope of the invention. The preceding examples can be repeated with similar success by substituting the generically or specifically described reactants and/or operation conditions of this invention for those specifically used in the examples. Accordingly, it is not intended that the invention be limited, except as by the appended claims.

Claims

What is claimed is:

Claim 1:

In the treatment of chronic immune conditions in a living mammal by optimizing immune activity, and the chronic immune condition is the Hepatkis-C virus, a method for placing the Hepatitis-C virus into remission in the living mammal, characterized by; reducing the inflammation of the hepatocytes and by reducing viral damage to the hepatocytes in a living mammal, by administering to the mammal a safe and effective amount of (a) inositol hexaphosphate or a physiologically acceptable salt thereof in the amount not to exceed 285 mg/kg per day. Claim 2:

In the treatment of chronic immune conditions in a living mammal by optimizing immune activity, and the chronic immune condition is the Hepatitis-C virus, a method for placing the

Hepatitis-C virus into remission in the living mammal, characterized by; reducing the inflammation of the hepatocytes a Uving mammal, by administering to the mammal a safe and effective amount of (a) inositol hexaphosphate or a physiologically acceptable salt thereof in the amount not to exceed 285 mg/kg per day.

Claim 3:

In the treatment of chronic immune conditions in a living mammal by optimizing immune activity, and the chronic immune condition is the Hepatitis-C virus, a method for placing the Hepatitis-C virus into remission in the Uving mammal, characterized by; by reducing viral damage to the hepatocytes in a living mammal, by administering to the mammal a safe and effective amount of (a) inositol hexaphosphate or a physiologically acceptable salt thereof in the amount not to exceed 285 mg/kg per day.

Claim 4: In the method of Claims 1 to 3, and further characterized by; the amount of inositol hexaphosphate administered is 115 mg/kg. per day.

Claim 5:

In the method of Claims 1 to 3, and further characterized by; the amount of inositol hexaphosphate is administered parenterally in a dose adjusted for parenteral delivery. Claim 6:

In the method of Claims 1-3, and further characterized by; the amount of inositol hexaphosphate is administered oraUy.

Claim 7:

In the method of Claims 1-6, and further characterized by; adding to composition (a) the additional composition (b) a 50/50 mixture of beta-sitosterol, and beta-sitosterolin, in the ratio of weight in miUigrams of (a): (b), from about 8000 to 10000 miUigrams of (a), and from about 5 to 50 miUigrams of (b).

Claim 8: In the method of Claims 1 to 7, and further characterized by: adding to composition (a) the additional composition (c) inositol or a physiologically acceptable salt thereof in a ratio by weight of (a): (c) from about 10:1.

Claim 9:

A method as recited in Claims 7 and 8, and further characterized by; administering the combination by weight not to exceed 20 grams per day for a 70 kg individual..

Claim 10

A method as recited in Claim 8, and further characterized by; administrating the combination by weight of eight grams of inositol hexaphosphate or a physiologically acceptable salt thereof, and less than one gram of inositol or a physiologically acceptable salt thereof. Claim 11:

A method as recited in Claims 1 to 6, and further characterized by; adding to composition (a) the additional composition (b) N-Acetyl Cysteine.

Claim 12:

A method as recited in Claim 11 , and further and further characterized by; adding to compositions (a) and (b) the additional composition (c) Alpha Lipoic Acid.

Claim 13:

A method as recited in Claims 12, and further characterized by; the weight in milligrams of N-

Acetyl Cysteine being from about 200 to 1500 and the weight in milligrams of Alpha Lipoic

Acid being from about 50 to 300. Claim 14:

In the method of Claims 7 through 13, and further characterized by; adjusting the amount administered parenteraUy in a dosage adjusted for a parenteral deUvery system.

Claim 15:

In the method of Claims 7 through 13, and further characterized by; administering the composition oraUy.

Claim 16:

Hepatitis-C virus into remission in the living mammal; characterized by; reducing the inflammation of the hepatocytes and by reducing viral damage to the hepatocytes in a Uving mammal, by administering to the mammal a safe and effective amount of (a) inositol hexaphosphate or a physiologically acceptable salt thereof, (b) N-Acetyl Cysteine, and (c) Alpha Lipoic Acid, in the ratio of weight in milligrams of (a):(b): (c): from about 8000 to 10000 milUgrams of (a), from about 200 to 1500 milligrams of (b), from about 50 to 300 milligrams of (c).

Claim 17:

A method as recited in Claim 16, and further characterized by; adding to composition of (a), (b), and (c), the additional composition (d) inositol or a physiologically acceptable salt thereof in a ratio of (a) to (d) from about 10:1. Claim 18:

A method for optimizing immune activity in the treatment of chronic immune conditions in a mammal, wherein the chronic immune conditions include cancer, aids/hiv, hepatitis-c, herpes, colds, influenza, bronchitis, chronic fatigue and Epstein Barr, characterized by; administering to the mammal a safe and effective amount of a mixture of (a) inositol hexaphosphate or a physiologically acceptable salt thereof, (b) N-Acetyl Cysteine, (c) Alpha Lipoic Acid, and (d) a 50/50 mixture of beta-sitosterol, and beta-sitosterolin, in the ratio of weight in milligrams of (a):(b): (c): (d) from about 8000 to 10000 milligrams of (a) from about 200 to 1500 milligrams of (b), from about 50 to 300 milUgrams of (c), and from about 5 to 50 milUgrams of (d). Claim 19 A method and composition as recited in Claim 18, characterized by; improving the immune system of said HTV infected individual through bodily mechanisms including intracellular communication, gene regulation, gene repair, and membrane effects, and for improving the CD4 count in said individual, and for improving the CD4 to CD8 ratio, and for reducing the beta 2 microglobulin levels, and for reducing the CD8 count, and for reducing the number of opportunistic infections. Claim 20:

In a mammalian immune system of the type that produces a number of T-ceUs that in turn produce both interferon and regulates antibody production, and of the type that produces natural killer cells, a method for optimizing such immune system in the treatment of chronic immune conditions, such as cancer, aids/hiv, hepatitis-c, herpes, colds, influenza, bronchitis, chronic fatigue and Epstein Barr, characterize by; administering to the mammal a safe and effective amount of a first mixture of (a) inositol hexaphosphate or a physio logicaUy acceptable salt thereof, (b) about a 50/50 second mixture of beta-sitosterol, and beta-sitosterolin, in the ratio of weight in inilUgrams of (a):(b) from about 8000 to 10000 milUgrams of (a), and from about 5 to 50 milUgrams of (b), said inositol hexaphosphate provides the foUowing technical advantages including (1) enhancing the activity of natural killer cells to reduce viral load, (2) preventing genetic damages within the ceUs, (3) blocking the formation of cancer ceUs, (4) reducing or eliminating oxidative damage caused by at least super oxide molecules and or free radicals, said mixture of beta-sitosterol and beta-sitosterolin provides the foUowing technical advantages including (5) encouraging the growth of more T-ceUs, (6) for encouraging such T-ceUs to produce both more interferon and regulates antibody production, and (7) for enhancing the effectiveness of natural killer ceUs so produced. Claim 21: In the method of Claim 20, and further characterized by; adding to compositions (a) and (b) the additional compositions of (c) N-Acetyl Cysteine, and (d) Alpha Lipoic Acid, in the ratio of weight in miUigrams of (a):(b): (c): (d) from about 8000 to 10000 milligrams of (a) from about 5 to 50 miUigrams of (b), from about 200 to 1500 milligrams of (c), and from about 50 to 300 milUgrams of (d), said Alpha Lopoic Acid provides the foUowing technical feature of reducing oxidative stress to the ceUs.