Drink Product Containing Genistein And Use Thereof Patent Application (2025)

U.S. patent application number 17/330223 was filed with the patent office on 2021-09-09 for drink product containing genistein and use thereof. The applicant listed for this patent is HYGIA PHARMACEUTICALS, LLC. Invention is credited to Barbara Brooke Jennings.

DRINK PRODUCT CONTAINING GENISTEIN AND USE THEREOF

Abstract

A drink product having as an active ingredient genistein and aninositol hexaphosphate and/or an unphosphorylated inositol andoptionally additional inositol (unphosphorylated as well ashexaphosphorylated) moieties. Hexaphosphates for use in theinvention include myoinositol hexaphosphate and/or any of the other8 optical isomers thereof. The optional additional inositolsinclude myoinositol and/or any of the other 8 optical isomersthereof. Uses for prevention, treatment, and reduction in risk ofdeveloping or progression of a number of conditions aredisclosed.

Related U.S. Patent Documents

Claims

1. An aqueous liquid formulation comprising: (a) water and (b)myoinositol hexaphosphate and/or an optical isomer thereof, and/oran orally acceptable salt thereof, (c) Genistein (d) furtheroptionally comprising one or more components selected from thegroup consisting of: (1) myoinositol and/or optical isomer; (2) anorally acceptable free radical scavenger other than Genistein; (3)a nutritionally acceptable orally administrable electrolyte; (4) anutritionally acceptable orally administrable vitamin; (5) aflavor; (6) an orally administrable coloring agent; (7) an orallyadministrable sweetener; (8) an oral formulation acceptablethickener; (9) an orally administrable, liquid formulationprocessing aid; and, (10) an orally administrable, liquidformulation auxiliary carrier other than water.

2. A method of reducing the risk of damage to cells or tissues dueto reactive oxygen species free radicals in a subject in needthereof comprising orally administering the formulation of claim1.

3. A method of preventing damage to cells or tissues due toreactive oxygen species free radicals in a subject in need thereofcomprising orally administering the formulation of claim 1.

4. A method of treating damage to cells or tissues due to reactiveoxygen species free radicals in a subject in need thereofcomprising orally administering the formulation of claim 1.

5. A method of reducing the risk of developing HIV and/or AIDS andsecondary cancers related to HIV and AIDS comprising orallyadministering the formulation of claim 1.

6. The method of claim 5 wherein said cancers related to HIV andAIDS is selected from Kaposi sarcoma and non-Hodgkin lymphoma,Hodgkin disease and cancers of the lung, mouth, skin, cervix, anddigestive system, liver, blood, soft tissue, and musculartumors.

7. A method of preventing a HIV/AIDS related cancer selected frombreast, pancreatic, ovarian, prostate, lung cancer, skin cancer,colon cancer liver, cervical, uterine, liver, blood, soft tissue,and muscular tumors in a subject in need thereof comprising orallyadministering the formulation of claim 1.

8. A method of treating a cancer selected from Kaposi sarcoma andnon-Hodgkin lymphoma, other AIDS-related cancers selected fromHodgkin disease and cancers of the lung, mouth, skin, cervix, anddigestive system, liver blood, soft tissue, and muscular tumorsbreast, pancreatic, ovarian, prostate, lung cancer, skin cancer,coln cancer liver, cervical, uterine, liver, blood, soft tissue,and muscular tumors in a subject in need thereof comprising orallyadministering the formulation of claim 1.

9. A method of increasing T cells and or inhibiting HIV related CD4reduction comprising administering the composition of claim 1 to asubject in need thereof

10. A method for blocking the communication between a HIV cellsurface to internal cellular compartment comprising administeringthe composition of claim 1 to a subject in need thereof.

11. A method for preventing an HIV particle from entering theinternal cellular compartments thereby preventing the spread of theinfection comprising administering the composition of claim 1 to asubject in need thereof.

12. A method of reducing the risk of adverse effects of common andcurrent drug toxicities' associated with current anti-viraltherapies comprising administering the composition of claim 1 to asubject in need thereof.

13. A method of reducing drug resistance comprising administeringthe composition of claim 1 to a subject in need thereof.

14. A method for both prevention HIV infection of resting CD4T-cells, viral DNA synthesis, and/or viral nuclear migrationcomprising administering the composition of claim 1 to a subject inneed thereof.

15. A method for preventing Gag-Na inositol does that interactionsprior to membrane binding in HIV comprising administering thecomposition of claim 1 to a subject in need thereof.

16. A method for inhibiting the replication of HIV-1 comprisingadministering the composition of claim 1 to a subject in needthereof

17. A method for AP3B1 regulation and HIV-1 Gag release comprisingadministering the composition of claim 1 to a subject in needthereof.

18. The product of claim 1 which is a liquid nutritionalsupplement.

19. The product of claim 1 which is an orally administeredproduct.

20. A method of reducing the risk of damage to cells or tissues dueto reactive oxygen species free radicals in a subject in needthereof comprising orally administering the formulation of claim1.

21-30. (canceled)

Description

FIELD OF THE INVENTION

[0001] This invention relates to certain drink products thatgenerally are aqueous solutions containing genistein, myoinositolhexaphosphate (and or any of the optical isomers thereof)optionally enriched with any or all of myoinositol optical isomersof myoinositol, electrolytes, flavors, vitamins, free radicalscavengers, and sweeteners. The invention further relates to (a)the treatment of and/or (b) the prevention of and/or (c) thereduction in the risk of developing various conditions such ascancers, particularly, lung, skin, prostate, and colon cancersand/or the :prevention, and/or (d) reducing the risk of developingHIV and/or AIDS and secondary cancers related to HIV and AIDSand/or (e) prevention infection of resting CD4 T-cells, viral DNAsynthesis, and viral nuclear .migration. The invention furtherrelates to the inhibition of HIV-1 in a T cell line, the preventionand/or inhibition of the early replicative stage of HIV. Stillfurther, the invention relates to superior cocktails for use inHIV/AIDS treatment, prophylactic treatment in subjects in need ofsuch prophylactic treatment due to either low level detection ofHIV/AIDS titers or surrogates therefor or due to suspected exposureto HIV/AIDS virus prior to detection of HIV/AIDS titers orsurrogates therefor.

BACKGROUND OF THE INVENTION

[0002] A significant statistic has recently shown that a personborn in the United States today has a 41% lifetime risk of beingdiagnosed with. some type of cancer. There are approximately, 3.4million. are currently living with HIV/AIDS. Indeed these arealarming statistics. It is so alarming that many healthorganizations have urged researchers to identify effective. methodsto prevent cancer and the spread of HIV infections to full blownAIDS. Both cancer cells and viruses exhibit deregulations multiplecellular signaling pathways. Viruses and cancers share similargenetics. Some would even report that viruses are one of the majorcauses of cancers. Furthermore, all cancers and HIV infected cellsshare a number of common hallmark capabilities, such as: Geneticinstability, self-sufficiency in growth signals, insensitivity todrugs, avoidance of apoptosis, unlimited replication, sustainedinternal cellular compartment invasion, metastasis and/ormalignancies Therefore, it would be ideal to utilize specificagents that can both target multiple signaling pathways and orproteins. Compounds that can only target a single pathway or aprotein in cancer as well as in HIV infections are tactics thatfrequently fail. Genetic instability produces intra-tumoralheterogeneity and viral heterogeneity (viral mutant) thatfrequently enables adaptive resistance or drug resistance overtime.Indeed, current combination chemotherapy that targets a number ofdistinct molecular mechanisms in both cancer and in HIV infectionsis preferable and considered more promising, but the use ofmultiple agents known in art is often constrained due tocorresponding increases in toxicity overtime, most of the timedamaging major organs or causing secondary malignancies.Accumulating evidence has shown that some natural products such asinositols and genistein have signaling inducing effects both invivo and in vitro in both cancer and in HIV. Their mechanism ofactions appears to be made possible by site-specific action onmultiple cellular signaling pathways without causing undesiredtoxicity in normal cells. Therefore, these non-toxic natural agentsin a drink could be useful in combination with conventionalchemotherapeutics and anti-virals, this can be used as preventive,or as an adjunct, or complementary.

[0003] Sun tanning is the result of sun radiation and free radicaldamage. This occurs when radiation from the sun is converted intooxygen-free radicals (reactive oxygen. species, aka ROS) thatdamage the skin and its most of its support structure upon longterm exposure. Free radical scavengers as well as myoinositolhexaphoshosphate (IP6) have been shown to neutralize this oxidativestress in the skin which can be caused by both UVA and UVBradiation and prevent three types of skin cancers.

[0004] According to the CDC, cigarette smoking is the number onerisk factor for lung cancer. There are few targeted treatmentoptions. In the United States, cigarette smoking causes about 90%of lung cancers. The world's two most populous nations--India andChina--are home to more smokers than the entire population of the.European Union. In China, more than 300 million people are tobaccousers, while India adds another 275 million to the tally.

[0005] A study by the George Institute of Global Health in 2010revealed that the Asia-Pacific region is home to 30 percent of theworld's smokers. The impact of smoking is greatest in thesecountries because smokers who develop lung cancer are diagnosed atlater stages of the disease and receive less effective treatment.People who smoke are 15 to 30 times more likely to get lung canceror die from lung cancer than people who do not smoke.

[0006] Existing literature has demonstrated a clear therapeuticbenefit of inositol-1,2,3,4,5,6-hexakisphosphate, referred toherein as IP6, in high fiber diets and a growing number ofscientific studies have demonstrated that IP6 hasanti-proliferative and tumor suppressive properties and cancerprevention properties in numerous tumor types including skincancers. The best human clinical evidence to date for cancerprevention in smokers using an oral pill form of administration isbased on human clinical trials of smokers with dysplastic lunglesions that were reversed taking oral myoinositol.

[0007] Oral administration of IP6 has been shown to protect againstlung and colon cancer and the prevention UVA/UVB induced skintumors in basal, squamous, and melanoma skin tumors.

[0008] IP6 is a (poly) phosphorylated carbohydrate, ubiquitous innature and synthesized in all animal cells. It functions as theprinciple storage form of phosphorous in many plants. It alsooccurs naturally in cereal grains, beans, brown rice, corn, sesameseeds, wheat bran, and other high fiber foods. Indeed, studiessuggest that some of the health benefits afforded by eating a highfiber diet can be attributed to IP6 action. Copious amounts of highfiber is not practical for everyone and the human mall intestinehas very limited enzymes to break down this phosphate in order toreap the anti-cancer benefits associated with this compound.Furthermore, this phosphate gets bound to food proteins in theintestine and consequently largely degraded by stomach acids.Therefore a supplement for oral or an ionized aqueousadministration having IP6 phytate is highly desirable.

[0009] Unlike rodents, the small intestine of humans express lowlevels of phytase, and this enzyme is required to metabolize IP6.Therefore, IP6 is not a source of dietary inositol and phosphate.Rather myoinositol polyphosphates are synthesized within the bodydirectly from phosphate and inositol, the latter being derived fromglucose. IP6 ranges in concentration from 10 to 100 .mu.M inmammalian cells. Importantly, phytic acid, chelates severalimportant minerals including zinc, iron, and to a lesser extentcalcium and magnesium.

[0010] Inositol phosphates function as intracellular signalingintermediates that regulate a. number of critical biochemicalpathways in mammalian. cells including cell cycle progression, celldifferentiation, survival, migration, intracellular vesicletransport, metabolism and autophagy, indeed, a key regulator of theactivity of phosphatidylinositol (Ptdlns) lipid substrates is theenzyme phosphatidylinositol 3-kinase (PI3K) which is the majorcancer causing protein involved in all cancerous tumors. Thisenzyme phosphotylates the 3-OH residue of the myo-inositol ring ofthree specific Ptdlns; phosphatidylinositol,phosphatidylinositol-4-phosphate, andphosphatidylinositol-4,5-bisphosphate. PI3K activity plays animportant role in regulating the activity of other kinases thatplay important roles in metabolism and cell growth and survivalincluding AKT (protein kinase B) and mTOR (mammalian target ofrapamycin). Indeed, dysfunction and/or aberrant regulation of ThePI3K pathway is implicated in cancers of the colon, breast, brain,liver, stomach, and lung. Therefore, development of potent andSelective PI3K inhibitors as novel cancer therapeutics is currentlythe focus of intensive research efforts. However, first generationPI3K inhibitors developed in the art exhibited toxic side effectsand poor pharmacological properties and selectivity, and as suchwere only effective in preclinical models. Alternatively, thereexists a large amount of epidemiological data indicating thatinositols are protective against certain forms of cancer. Indeed agrowing body of literature has linked the therapeutic benefits tonatural products, such as IP6. Although IP6 has been shown tofunction as a free radical scavenger, other studies havedemonstrated that it also functions as a PI3K inhibitor.Furthermore, several studies have shown that the ability of IP6 toblock cell transformation or growth of tumor cells is directlyrelated to inhibition of PI3K activity. For example, Huang et. al.(1997) reported that IP6 at a concentration range of 0.5-2 mMshowed a dose-dependent inhibition of EGF or TPA-induced celltransformation in JB6 cells as measured by three-dimensional growthin soft agar. This activity was linked to direct inhibition ofPI3K. Similarly, Gu et al. (2009) showed that IP6-mediated growthinhibition of the prostatic adenocarinoma cell line PC-3 wascorrelated with reduced phosphorylation levels of the p85 subunitof PI3K at Tyr.sup.458 and phosphoinositide-dependent kinase-1PDK1) at Ser.sup.241. IP6 also caused a strong decrease in levelsof integrin linked kinase 1 (ILK1) and cyclin D1 and reduced levelsof phosphorylated AKT and GSK3.alpha./.beta. in these cells.

[0011] Based on these results and other data in both experimentalanimal models and human clinical trials demonstrating a therapeuticbenefit of IP6 in preventing cancer, these products can he used asa prophylactic to protect against. environmental insults that areimplicated in tumor promotion via modulation of the RI3K/AKT/mTORpathway.

[0012] More people die of lung cancer in, the U.S. than any othertype of cancer. This is true for both men and women. Mostimportantly, the overall 5-year survival rate for patientsdiagnosed with lung cancer is .about.12% for men and .about.16% forwomen. While smoking is the main cause of lung cancer, e.g. maleand female smokers are 23 and 13 times more likely to develop lungcancer than non-smokers, respectively, 15% of all lung cancerpatients have never smoked. Most importantly, no reliable metricsexists that can predict whether a smoker will develop lung cancer.Since most lung cancer patients are diagnosed with advanceddisease, this knowledge is critical for developing adjuvant andfront line therapies to improve survival of lung cancerpatients.

[0013] Several studies have shown that myoinositol has protectiveeffects in experimental models of lung cancer. For example,Estensen and Wattenberg reported that a diet containing 3%myo-inositol fed beginning 1 week after exposure to benzo[a]pyrenereduced the number of pulmonary adenomas by 40%.

[0014] These studies are significant in that benzo[a]pyrene is apolycyclic aromatic hydrocarbon found in automobile exhaust fumes,cigarette smoke, and charbroiled food metabolites, and itsmetabolites are both highly mutagenic and carcionogenic. Indeed,benzo[a]pyrene has been directly linked to lung and colon cancer.These results were confirmed by Hecht et al, and Witschi et alusing a similar model of benzo[a]pyrene with or without4-(methylnitrosamino)-1-(3-pyridyly)-1-butanone, the latter ofwhich is also a component of cigarette smoke. Moreover, Witschi etal further demonstrated that a diet supplemented with 10 g perkilogram of myoinositol and 0.5 mg/kg dexamethasone (a steroid)produced a significant reduction in both lung tumor multiplicityand in tumor incidence as compared to a control diet in miceexposed to tobacco smoke. In these studies, mice were exposed to 71mg total suspended particulates (TSP)/m.sup.3 for the first twoweeks, 86 mg/m.sup.3for three additional weeks, and 132 mg/m.sup.3for an additional 17 weeks for 6 hr per day, 5 days per week. Inthese studies, the diet containing myo-inositol/dexamethasoneproved to be a highly effective chemopreventive regimen. The numberof tumors per lung in animals fed myoinsoitol dexamethasone andexposed to tobacco smoke actually approached the, tumormultiplicity in animals exposed to filtered air.

[0015] Recently, a landmark study published by Gustafson et al. inthe high impact journal Science Translational Medicine revealedthat the PI3K pathway is activated in cytologically normal proximalairway epithelial cells in smokers with tuna cancer and withdysplastic lesions. In these studies, PI3K activity was measuredbiochemically in airway biopsies by Western blot analysis andcomputationally by genome-wide micro-array analysis. This analysisrevealed that the PI3K pathway was significantly up regulated inthe airways of smokers with lung cancer as compared to controls,and genes that play a role in phosphatidylinositol signalingpathway were also significantly up regulated. Methodologies used toevaluate lung cancer patients were continued by demonstrating thatPI3K signaling was also up regulated in basal-like andHER2-overexpressing breast tumors that lack PTEN function, anegative regulator of the PI3K pathway. Moreover, this analysisshowed that the PI3K pathway signature was expressed at higherlevels in lung tumors as compared to adjacent normal tissue,indicating that PI3K activation is important for lung cancertumorigenesis.

[0016] The work by Gustafson et al. demonstrated that smokers withregression of dysplasia following treatment with myoinositol showedsignificant (p<0.05) increased expression of genes that arerepressed on PI3K activation in vitro, while smokers who did notrespond to myo-inositol treatment had no change in the PI3K genesets. The decrease in PI3K activity in patients who respond tomyoinositol suggests that regression of dysplasia is associatedwith a reduction of PI3K pathway activity in the proximal airway.The authors subsequently showed that treatment of a lungadenocarcinoma cell line with myoinositol resulted indose-dependent decreases in PI3K activity. Indeed, the medianeffective concentration (EC.sub.50) of myoinositol for PI3Kinhibition was 7.3.times.10.sup.-8 M. This EC.sub.50 is comparableto the myoinositol doses given for regression of dysplastic lesionsto high-risk smokers, which was 9 g twice daily (Lam S et al.,2006). These findings suggest that the cancer chemopreventionproperties of myoinositol are most likely related to inhibition ofPI3K activity.

[0017] Safety and efficacy of myoinositol has already beenestablished in a phase clinical trial-Mayo Clinic (Lam et al.2006). In this trial, sixteen smokers between 40 and 70 years ofage with greater or equal to 30 pack-years of smoking history andone or more sites of bronchial dysplasia were enrolled in a doseescalation study of myo-inositol for one month. Subsequently, tensubjects were enrolled in a 3 month study employing the maximumtolerated dose, which was found to be 18 grams per day administeredvia oral administration. Side effects, when present, were mild andmainly gastrointestinal in nature. More importantly, a significantincrease in the rate of regression of preexisting dysplasticlesions was observed (91% versus 48%; P 0.014) and a statisticallysignificant reduction in the systolic and diastolic blood pressuresby an average of 10 min Hg was observed. Therefore, these datademonstrate that myoinositol in a daily dose of 18 grams per dayfor 3 months is safe and well tolerated and produces significantregression of pre-existing dysplastic lesions in smokers.

[0018] A wealth of epidemiological data exists showing thathigh-fiber diets are associated with lower risks of largeintestinal cancer. Since IP6 levels are high in nuts and grains,several studies have directly evaluated the cancer fightingproperties of IP6 in experimental animals of colon cancer. Forexample, Shamsuddin et al. (1988) first demonstrated that rats rsupplemented with 1% sodium IP6 before or two weeks post treatmentwith the carcinogen azoxymethane exhibited a 35% decrease in largeintestinal cancer. A follow up study conducted by Shamsuddin andUllah (1989) further showed that treatment of rats with IP6 waseffective in significantly (p=0.02) reducing large intestinalcancers even when the treatment was begun 5 months aftercarcinogenic induction with azoxymethane. Consistent with thesedata, IP6 administration also reduced early biomarkers of coloncancer risk including the degree of aberrant crypt loci andlabeling index of crypt cells in rodents (Jenab and Thompson, 1998;Norazalina et al., 2010). These studies are consistent with otherreports indicating that IP6 inhibits growth of the human coloncancer cell lines in vitro (Sakamoto et al. 1993; Tain and Song,2006), lowered their metabolic activity (Schroterova et al., 2010),and decreased the number of cells in S-phase by inducing G0/G1arrest (El-Sherbiny et al. 2001).

TABLE-US-00001 TABLE A Antitumor effect of inositol hexaphosphate(IP6) in- vitro Organ/Tissue Species Cell Line Investigator BloodHuman Erythroleukemia K562 cell Shamsuddin et al line, K562 1 humanbone Deliliers et al. ( marrow Colon Human Adenocarcinoma, Sa Yang& Shamsuddin HT-29 cell line Samoto et al Lung Rat Trachaelepithelial + Arnold et al. B[a]P Liver Human Hep G2 cells Vuceniket al. Mammary Human Adenocarcinoma Shamsuddin et al. MCF-7, MDA-MB231 cells Uterine cervix Human HeLa cells Ferry et al. ProstateHuman Adenocarcinoma Shamsuddin & Yang Zi et al. Human P DU145cells DC-3 cell line Singh et al. Skin Mouse JB6 cells Huang et alMouse HEL-30 cells Nickel & Belury Babich et al. mice melanomaline HTB68 Rizvi, et al also see references below for other skincancer cell lines and investigator authors Soft tissue Mouse 3T3fibroblast Babich et al. Vucenik et Human Rhabdomyosarcoma, RDcells al.

[0019] Inositols are available as dietary supplements. IP6,inositol, and D-chiroinositol are sold in pill or powder form.Inositol and D-chitninositol are advertised as members of thevitamin B complex (Vitamin B.sub.8). However, this classificationis outdated since they are produced from glucose in the body and assuch are not essential nutrients. Inositol is advertised as usefulin ameliorating symptoms associated with anxiety and depression. Indouble blinded clinical trials, D-chiro-inositol provided asubstantial benefit to women with polycystic ovary syndrome(Nestler, 1999; Iuorno, 2002).

OBJECTS OF THE INVENTION

[0020] It is an object of the invention to provide a liquid and/orionized aqueous Genistein containing product containing myoinositolhexaphosphate (and/or optical isomer thereof) as a dietarysupplement and/or medical treatment.

[0021] It is another object of the invention to provide a liquidproduct containing genistein, myoinositol hexaphosphate (and/oroptical isomer thereof) together with myo-inositol (and/or opticalisomer thereof) as a dietary supplement and/or as a medicaltreatment.

[0022] A still further object of the invention is to provide aliquid product as described in any of the foregoing objects of theinvention which further contain a free radical scavenger.

[0023] Yet another object of the invention is to provide a liquidproduct as described in any of the foregoing objects of theinvention further comprising at least one non-inositol Bvitamin.

[0024] An even further object of the invention is to provide aliquid product as described in any of the foregoing objects of theinvention further comprising at least one additional nutritionalsupplement or neutraceutical component.

[0025] A still further object of the invention is the use of any ofthe foregoing liquid products as a nutritional supplement in humansor animals.

[0026] Yet another object of the invention is the use of any of theforegoing liquid products in an oral method for the treatment,prevention, and/or reduction of risk of a cancer selected from thegroup consisting of skin (including squamous cell carcinoma, basalcell carcinoma, and melanoma), lung, pancreatic, breast, liver,blood, soft tissue, ovarian, prostate and/or colon cancers (seetable and references), or in a method of the treatment of damagefrom or prevention of damage from or reduction of the risk ofdamage from reactive oxygen species in a human or animal in needthereof.

[0027] Still another object of the invention is the use of any ofthe foregoing liquid products in an oral neutraceutical ornutritional supplement product, where such product is used in amethod for the treatment, prevention, and/or reduction of risk of acancer selected from the group consisting of skin, lung, prostate,and/or colon cancers, or in a method of the treatment of damagefrom or prevention of damage from or reduction of the risk ofdamage from reactive oxygen species in a human or animal in needthereof or as a nutritional supplement for use in the support ofhealth with respect to any of the above.

[0028] Still other objects of the invention will be apparent tothose of ordinary skill once having the benefit of the presentdisclosure.

DETAILED DESCRIPTION OF THE INVENTION

[0029] The present invention is an oral, aqueous liquid formulationcontaining myoinsoitol hexaphosphate (IP6) in an effective amountas a nutritional supplement; and/or an effective amount as amedicinal for the treatment of, prevention of, or reduction of therisk of developing a cancer of the skin, lung, prostate, or colon;and/or an effective amount for the treatment of, prevention of,and/or reduction in the risk of damage to cells caused by reactiveoxygen species (ROS). Other utilities and aspects of the presentinvention include protection of those going to high elevations(particularly pilots, extreme mountain climbers, as well asastronauts) as a protectant prophylactically against radiationexposure due to lesser protective effects of the atmosphere againstambient radiation, and environmental toxins, i.e car exhaust,pollution, radiation, and known toxic free radical generatingchemicals. (One particularly troublesome group of compound in theenvironment includes phthalates, which are known to generate freeradical oxygen species in vivo, and thus, the present invention isuseful to offset the undesirable effects thereof.) Similarly, thepresent invention is also useful as a prophylactic measure againstsome of the accidental or routine radiation exposure involved withnuclear power plant operators and those involved in mining andrefining of radioactive materials. It should be realized that thepresent invention is not expected to fully cure or fully preventsuch effects of radiation exposure, but is of use in minimizing orreducing the effects that would result in the absence of use of theinvention or any other preventative measure. Still furtherutilities for the present invention include usage before, during,or after radiation treatments, which radiation treatments areeither for disease treatment (as in radiation for cancer therapy)or diagnostic purposes, such as CAT scans, X-rays, etc., as apartial protectant against at least some of the undesirable effectsof such radiation exposure.

[0030] In addition to the IP6 (and/or optical isomer thereof) andwater, the formulations optionally may also contain, one or more ofmyoinositol (and/or optical isomer thereof). Still further optionalcomponents of the present formulation include nutritionallyacceptable monovalent electrolytes (including without being limitedthereto, cations such as, without limitation sodium, and potassium,and anions such as, without limitation. chloride; non-limitingexamples of which include sodium chloride, and potassium chloride)as are known in the nutritional supplement arts and/or vitamins(including, without limitation thereto the B vitamins (includingwithout limitation thiamine (vitamin B1); riboflavin (vitamin B2);niacin and/or nicotinamide (vitamin B3); pantothenic acid (vitaminB5); pyridoxine, pyridoxal, pyridoxamine, and/or pyridoxine HCl(vitamin B6); biotin (vitamin B7); folic acid (vitamin B9), andcobalamine (vitamin B12)) and vitamin C), as well as herbalextracts. (Nutritionally available salts and esters of the variousvitamins may be used in place of the specifically stated vitamin.)The above vitamins and electrolytes are used in amounts such thatfrom 1 to 4 doses (whether as 30 ml, 60 ml, 90 ml, 120 ml, 150 ml,180 ml, or 240 ml per dose) delivers from 1/4 to the full US RDAindependently for each one present in a particular formulation(although lesser amounts are acceptable but just not preferred).The formulations of the invention may also optionally contain oneor more of flavors (such as without limitation, coconut, grape,blueberry, pomegranate, apple, strawberry, kiwi, dragonfruit,lemon, lime, raspberry, mango, .etc), sweeteners (such as withoutlimitation, sucrose, fructose, glucose, stevia, aspartame,rebaudioside A, sucralose, mannitol, xylitol, syrups, etc.),colorings, stabilizers, pH adjusters, preservatives (such aswithout limitation, sodium benzoate), etc, as well as thickenersand processing aids as may be generally known in the beverageand/or liquid nutritional supplement arts in amounts generallyknown as acceptable in the art.

[0031] Effective amounts of the IP6 component (or optical isomersthereof, preferably myoinositol hex aphosphate), when used withoutother inositol components range from about 0.5 to about 4% w/v,preferably about 0.75 to about 3% w/v, more preferably about 1 toabout 2.5% w/v, still more preferably about 1.1 to about 2% w/v,even more preferably 1.2 to about 1.5% w/v, and most preferablyabout 1.25% w/v, with a daily dosing typically in the range suchthat about 0.5 to about 8 grams per day, preferably about 1.0 toabout 7 grams per day, more preferably about 1.2 to about 6 gramsper day, still more preferably about 2.4 to about 5.5 grams perday, yet more preferably about 3.6 to about 5.0 grams per day, andmost preferably about 4.8 grams per day of myoinositolhexaphosphate (and/r an optical isomer thereof) is administered.When combined with myoinositol (and/or an optical isomer thereof),the hexaphosphates (preferably myoinositolhexaphosphate) arecombined with the unphosphorylated inositols (preferablymyoinositol, aka vitamin B11) in a ratio of the hexaphosphates(most preferably myoinositol hexaphosphate) to unphosphorylatedinositols (most preferably myoinositol) of about 6;1 to 1:6,preferably about 5:1. to about 1:5, more preferably about 4:1 toabout 1:4, still more preferably about 3:1 to about 1:3, even morepreferably about 2:1. to about 1:2, most preferably about eachbeing a molar ratio. Other suitable ratios include, withoutlimitation, preferably about 4.5:1 to about 1:1, more preferablyabout 4.25:1 to about 3:1, still more preferably about4:1 of thehexaphosphates (most preferably myoinositol hexaphosphate) tounphosphorylated inositols (most preferably myoinositol) on a molarbasis. Nonetheless, the specific concentration in a given drink maybe more, or less (including multiple times or fractions thereof (ifthe volume of the drink per daily dose is properly adjusted tocompensate therefore). Thus, for example, for a 125% w/v solutionof IP6, where a drink is intended to deliver 3000 mg/240 ml with aserving or dose size of 240 ml (i.e. to deliver a 6 g dose ofmyoinositol hexaphosphate in two 240 ml doses, typicallyadministered as 240 ml twice daily), an alternate drink having1500mg/120 ml with a serving or dose size of 120 ml (either taken 4times a day or in the situation where a lower dosing is desired,less frequently), or another alternate of 62.5 mg/5 ml wheresignificantly lower amounts are desired. Adjustment of dosings forsmaller than average or larger than average adults or foradolescents or children will generally be within the skill of oneof ordinary skill in the art given the foregoing ranges for atypical adult. When used in combination with other inositolspecies, the specific amount of IP6 may be reduced somewhat, butpreferably, the other inositol species are added to the abovementioned amounts of IP6. The optional inositol species other thanIP6 are generally available in the art from various sources, butpreferably, the invention has IP6 optionally with or withoutmyoinositol as the only inositol species. When an IP6 is used incombination with an unphosphorylated inositol, the most preferredratio is stated above is a molar ratio of 1:1 and in a mostpreferable, but non-limiting embodiment, the total daily dose ofsuch a ratio is about 4.8 grams of the myolP6 (or isomer thereof)together with 1.32 grams of the unphosphorylated myoinositol (orisomer thereof).

[0032] As to the isomers of myoinositol, there may be usedscylloinositol, mucoinositpl, D-chiroinositol, neoinositolalloinositol, epiinositol, and/or cisinositol, with myoinositol,and D-chiroinositol being preferred and myoinositol being mostpreferred. As to the isomers of the myoinositol hexaphosphatecomponent, one may use the hexaphosphates of the correspondingmyoinositol isomers set forth in the preceding sentence, withmyoinositol hexaphosphate and D-chiroinositol hexaphosphate beingpreferred and myoinositol hexaphosphate being most preferred.

[0033] As the optional free radical scavengers, any orallyacceptable free radical scavenger known in the art is a isacceptable for use in the present invention, for example, withoutlimitation, N-Acetyl-L-cysteine, L-Ascorbic acid, Balsalazide(typically available as the disodium salt hydrate), Caffeic acid,(-)-Catechin gallate, Chlorogenic acid, Delphinidin chloride,Diosmin, Ellagic acid, (-)-Epicatechin, Fucoxanthin carotenoidantioxidant, (-)-Gallocateehin, (-)-Gallocatechin gallate,Ginkgolide B, 3-Hydroxytyrosol, Luteolin, Lycopene, Neoehlorogenicacid, Resveratrol, Rutin hydrate, Selena-L-methionine,Se-(Methyl)selenocysteine hydrochloride, and Sodium selenite, mostpreferably L-ascorbic acid. The optional orally acceptable freeradical scavengers can be used in amounts generally known asacceptable in the art; when ascorbic acid is used, it is preferablypresent in amounts of about 30 mg/120 ml of solution (i.e., about0.025% w/v) or 60 mg/120 ml of solution (about 0.05% w/v).

[0034] An additional known free radical/reactive oxygen scavenger,for use in the present invention is Genistein. In the presentinvention, when genistein is used, it is used in amounts in therange (in mg/kg/day) of from a lower end of about 1 to about 5 mgto an upper range end of about 10 to about 50 mg. Exemplary dosingranges (in mg/kg/day) include (without limitation) those with arange lower limit of about 1 mg, about 2 mg, about 3 mg, about 4mg, about 5 mg, about 6 mg, about 7 mg, about 8 mg, about 9 mg,about 10 mg, about 12.5 mg, about 15 mg, about 17.5 mg, about 20mg, about 25 mg, about 30 mg, about, 35 mg, and about 40 mg andhaving an upper end point of the range selected from about about 10mg, about 12.5 mg, about 15 mg, about 17.5 mg, about 20 mg, about25 mg, about 30 mg, about 35 mg, about 40 mg, about 45 mg, andabout 50 mg. Within these ranges, preferred dosages are in therange (in mg/kg/day) of about 1 to about 30 mg, more preferablyabout 2 to about 20 mg, still more preferably about 3 to about 1.5mg, even more preferably about 5 to about 12.5 mg, most preferablyabout 10 mg. In the present invention, when used, it is used incombination with one or more the other inositiol isomers and/or theinositol hexaphosphate isomers mentioned herein, preferably thegenistein is used in combination with at least one unphosphorylatedinositol isomer and at least one hexaphosphorylataed inositolisomer. Whether the genistein is used in combination with inoitolswhich are (a)only non-phopsphoprylated inositol isomers or (b) onlyhexaphosphorylated inositol isomers, or (c) combinations ofuniphosphorytlated inositol isomers AND hexaphosphorylated inositolisomers, the benefits of the invention may be obtained. Thepreferred unphosphorpylated inotitol isomers for the genisteincontaining embodiments are selected from myoinositol andD-chiroinositol. Independently, the preferred phosphphorylatedinositol isomers for use in the genistein containing embodimentsare selected from myoinositol hexaphosphate and D-chiroinositolhexaphosphate. These Genistein and Insoitol isomeric combinations(whether phosphorylated or unphosphorylated or both) may be used asis or in combination with the other (non-inositol type) components(mentioned herein) in analogous manners as set forth herein withrespect to the compositions that do not mention Genisteinspecifically.

[0035] The combination use of Genistein and the inositols and/orthe Insositol. Hexaphosphates as described above gives rise to theability to prevent, delay, modulate, reduce, and treat HIVinfections, in a substantially enhanced, substantially non-toxicmanner, especially as compared to current medicinals for use in thetreatment and prophylaxis for HIV. Neither the inositol componentsnor the Genistein component have the known side effects orassociated drug toxicities' and/or drug resistance known to occurwith current drugs used to treat HIV and/or AIDS cancers anddisseminated diseases due to being plant-based, will likely sidestep the toxicity issues faced with current drugs, a commonoccurrence or by product of the everyday and life-long use of thepharmaceutical based regimen faced by HIV positive individuals.This product can be preventive, also an adjunct and/orcomplementary treatment because patients overtime do becomeresistant to their drugs due to HIV mutant infections. known tooccur in this disease. Without being confined to the theory, it isbelieved that instead of acting directly with the virus, genisteinblocks the many cellular processes that appear to be necessary forthe virus to infect cells by inducing a conformational change. Thisconformational change and signal block works along with theinositol isomer components (whether or not phosphoylated) in asynergistic manner with lesser side effects, and better complianceand better user acceptability to achieve positive outcomes. Thisallows for impeding viral DNA synthesis and impeding viral nuclearmigration so that the invention Genistein containing compositionscan be used in the prevention, treatment, and amelioration of HIVinfection of immune cells, especially resting CD4 T-cells.

[0036] The present invention offers IP6 in an aqueous oral form asa means to reap the therapeutic benefits of this natural product,particularly in lieu of or in addition to a diet high in fiber. Oneof the advantages of the present invention is that the delivery ofundigested phytate IP6 and the other inositol species are in a formin which they are not captured and broken down as readily as solidforms containing these agents.

[0037] As previously described, the present invention formulationis used for an oral delivery of the active agents therein for theprevention and/or treatment and/or reduction of the risk ofdeveloping cancers such as, without limitation, one or more of skincancer (inclusive of squamous, basal, and melanoma), breastprostate, ovarian, pancreatic, lung cancer, colon cancer livercancer, bone cancer, soft tissue cancer (such as withoutlimitation, muscular cancers) or a blood cancer (or as described inTable A above) and/or treatment of damage and/or prevention ofdamage and/or reduction of the risk of damage to cells by reactiveoxygen species free radicals that are generated in the body due toenvironment or metabolic insult. Environmental or metabolic insultmay arise from exposure to a wide variety of factors, includingradiation, known carcinogens, and known five oxygen radicalgenerating substances (such as in, without limitation, cigarettesmoke, pollutants, radiation exposure (whether natural, or createdin the. workplace, or incident to diagnostic tests and medicaltreatments, etc.). For the above purposes, a suitable(non-limiting, exemplary) dose of a formulation of the presentinvention having about 1% to about 4% w/v of myoinositolhexaphosphate (and/or optical isomer thereof) therein in an amountof about 30 ml to about 480 ml, preferably about 60 ml to about 360ml, more preferably 90 ml to about 270 ml, still more preferably360 ml, about 120 ml to about 240 ml, most preferably about 180 mlto about 240 ml at least once to 2 times per day, with variationsthereon that will be recognized by those of ordinary skill in theart for delivery of about 3 g to about 9 g of myoinositolhexaphosphate (and/or optical isomers thereof) on a daily basis foran average adult in 1-2 or 2-4 divided doses a day.

[0038] The formulations of the present invention most preferablyhave the inositol components thereof in solution and preferably areclear, although non-inositol portions of the formulation may makethe solution less than completely clear without departing from theinvention.

[0039] The following non-limiting examples are exemplary only anddo not have any limiting effect on the present invention.

EXAMPLE 1

[0040] The following Table I presents a set of inositolhexaphosphate isomers (alone or with an unphsophorylated inositol)for use in the present invention. Table II specifies amounts of thehexaphosphated inositol and the unphosphorylated inositolcomponents, and each is applied independently to the 90combinations in Table I. For clarity, all of the "A" cells in TableI have the respective hexaphosphate mentioned in the left handcolumn with no unphosphorylated inositol component. All of the "B"cells of Table I have the respective hexaphosphate in combinationwith unphosphorylated myo-inositol.

TABLE-US-00002 TABLE I Hexaphosphate Unphosphphorylated ComponentComponent A B C D E F G H I J 1. Myo- None Myo- Scyllo- Muco-D-chiro- L-chiro- Neo- Allo- Epi- Cis- inositol inositol inositolinositol inositol inositol inositol inositol inositol inositolHexaphosphate 2. scyllo- None Myo- Scyllo- Muco- D-chiro- L-chiro-Neo- Allo- Epi- Cis- inositol inositol inositol inositol inositolinositol inositol inositol inositol inositol Hexaphosphate 3. Muco-None Myo- Scyllo- Muco- D-chiro- L-chiro- Neo- Allo- Epi- Cis-inositol inositol inositol inositol inositol inositol inositolinositol inositol inositol Hexaphosphate 4. D-chiro- None Myo-Scyllo- Muco- D-chiro- L-chiro- Neo- Allo- Epi- Cis- inositolinositol inositol inositol inositol inositol inositol inositolinositol inositol Hexaphosphate 5. L-chiro- None Myo- Scyllo- Muco-D-chiro- L-chiro- Neo- Allo- Epi- Cis- inositol inositol inositolinositol inositol inositol inositol inositol inositol inositolHexaphosphate 6. Neo- None Myo- Scyllo- Muco- D-chiro- L-chiro-Neo- Allo- Epi- Cis- inositol inositol inositol inositol inositolinositol inositol inositol inositol inositol Hexaphosphate 7. allo-None Myo- Scyllo- Muco- D-chiro- L-chiro- Neo- Allo- Epi- Cis-inositol inositol inositol inositol inositol inositol inositolinositol inositol inositol Hexaphosphate 8. epi- None Myo- Scyllo-Muco- D-chiro- L-chiro- Neo- Allo- Epi- Cis- inositol inositolinositol inositol inositol inositol inositol inositol inositolinositol Hexaphosphate 9. Cis- None Myo- Scyllo- Muco- D-chiro-L-chiro- Neo- Allo- Epi- Cis- inositol inositol inositol inositolinositol inositol inositol inositol inositol inositolHexaphosphate

TABLE-US-00003 TABLE II % are w/v unless noted otherwise I II IIIIV V VI VII VIII IX Hexaphosphated 1% 2% 4% 1% 2% 4% 1% 2% 4%inositol of Table I Unphosphorylated 0.135% 0.27% 0.54% 0.27% 0.54%1.08% 0.54% 1.08% 2.16% inositol of Table I When present* Ascorbicacid 0.025% 0.025% 0.025% 0.05% 0.05% 0.05% 0.1% 0.1% 0.1% Water qsto qs to qs to qs to qs to qs to qs to qs to qs to 240 ml. 240 ml.240 ml. 240 ml. 240 ml. 240 ml. 240 ml. 240 ml. 240 ml. *Molarratios of hexaphosphates to unphosphorylated inositol in aboveTable II are either 0.5:1 or 1:1, or 2:1

[0041] Each of the 810 formulations resulting from Tables I and IIare packaged for introduction into the marketplace. For the sake ofclarity, a Table I cell 1B Table II Col I formulation has 1%myoinositol hexaphosphate; 0.135% myoinositol.

EXAMPLE 2

[0042] The following Table III utilizes each of the separateformulations of Example I except that additional nutritionalsupplement components are added. The amounts in Table III areexpressed as % of the US Recommended Daily Allowance (USRDA) forthe particular component in question, or if in mg, then mg/240 mlof solution.

TABLE-US-00004 TABLE IIIA Vitamin Or electrolyte a b c d e f g h iB1 5% 10% 15% 20% 5% 10% 15% 20% 5% B2 5% 10% 15% 20% 5% 10% 15%20% 5% B3 5% 10% 15% 20% 5% 10% 15% 20% 5% B5 5% 10% 15% 20% 5% 10%15% 20% 5% B6 5% 10% 15% 20% 5% 10% 15% 20% 5% B7 5% 10% 15% 20% 5%10% 15% 20% 5% B9 5% 10% 15% 20% 5% 10% 15% 20% 5% B12 5% 10% 15%20% 5% 10% 15% 20% 5% sodium 110 mg 110 mg 110 mg 110 mg 110 mg 110mg 110 mg 110 mg 110 mg potassium 450 mg 450 mg 450 mg 450 mg 450mg 450 mg 450 mg 450 mg 450 mg

[0043] Each of the formulations in Tables I-IIIA have the furtheroptional electrolytes and supplemental components such aspreservatives and stabilizers added in accordance with Table IIIB.Each of the resulting solution is bottled for distribution.

TABLE-US-00005 TABLE IIIB Component i ii iii iv v vi vii viii ixsodium none 55 mg 110 mg 220 none 55 mg 110 mg 220 110 mg potassiumnone none none none 450 mg 450 mg 450 mg 450 mg 450 mg Sodiumbenzoate None 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% malic acidnone 250 mg 250 mg 250 mg 500 mg 500 mg 500 mg 500 mg 1000 mg

EXAMPLE 3

[0044] A single specific formulation of the inventioncomprises:

[0045] 1distilled water [0046] 1:1 molar ratio Myo-Inositolhexaphosphate (myo-IP6) (4.8 grams) and myo-inositol (132grams),

[0047] crystalline fructose,

[0048] citric acid (preservative),

[0049] vegetable juice (color),

[0050] natural flavor,

[0051] ascorbic acid (vitamin C),

[0052] sodium citrate (electrolyte/antioxidant),

[0053] monopotassium phosphate

[0054] niacin (B3),

[0055] pamothenic acid (B5),

[0056] pyridoxine hydrochloride (B6),

[0057] cyanocobalamine (B12)

[0058] The above components are dissolved in the water and bottledfor distribution.

EXAMPLE 4

[0059] A particular formulation of the invention comprises

[0060] Carbonated water-Carbon dioxide,

[0061] Inositol hexaphosphate (4.8 grams) and myo inositol 1.32grams (1:1 molar ratio),

[0062] Erythritol(rebiana.TM.),

[0063] citric acid (preservative),

[0064] vegetable juice (color),

[0065] natural flavor,

[0066] artificial flavors,

[0067] ascorbic acid (Vitamin C),

[0068] sodium citrate (electrolyte),

[0069] Monopotassium Phosphate

[0070] niacin (B3),

[0071] pantothenic acid (B5),

[0072] pyridoxine hydrochloride (B6),

[0073] cyanocobalamine (B12)

[0074] The above components are dissolved id the water and bottledfor distribution.

EXAMPLE 5

[0075] A particular formulation of the invention comprises

[0076] Distilled and/or sterilized community tap water.

[0077] Myo inositol (4.8 grams)

[0078] granulated table sugar(14 grams),

[0079] citric acid,

[0080] high fructose corn syrup,

[0081] colors,

[0082] glucose,

[0083] fructose,

[0084] sodium citrate (preservative),

[0085] vegetable juice (color),

[0086] natural flavor,

[0087] ascorbic acid (vitamin C),

[0088] natural flavor,

[0089] sodium citrate (electrolyte),

[0090] monopotassium phosphate (electrolyte),

[0091] niacin (B3),

[0092] pantothenic acid (B5),

[0093] pyridoxine hydrochloride (B6),

[0094] cyanocobalamins (B12)

[0095] sufficient sodium chloride to bring the sodium content up to110 mg/240 ml,

[0096] The above components are dissolved in the water and bottledfor distribution.

EXAMPLE 6

[0097] 800 mg of myoinositol hexaphosphate and 220 mg ofmyoinositol were dissolved in 240 ml of distilled water to form adrink product of the present invention. The drink product wasconsumed twice a day.

EXAMPLE 7

Bottled Water of the Invention

[0098] Water, if not already either purified, distilled, orfiltered is subjected to an operation to obtain the water in apurified, distilled, or filtered state and if need be stored forfuture use. The water is then used to dissolve the components ofone of the foregoing formulations, and the result is bottled intoappropriate containers.

EXAMPLE 8

Bottled Carbonated Soft Drink of the Invention

[0099] Purified, distilled, or filtered water as obtained in theinitial step of Example 7 is used placed in a mixing tank. Thevarious components of the soil drink, which typically do notinclude the inositol components of the present invention, typicallysweeteners, "soft drink concentrate", and flavor are added to themixing tank. The inositol and hexaphosphate inositiol components,either as dry powders or concentrate solutions in water or as apre-blend is added to the mixing tank in bile embodiment before"soft drink components" or thereafter in a second embodiment. Thesolution is then subjected to a carbonation process and the resultis bottled in suitable containers.

EXAMPLE 9

Bottled Ready to Drink Tea of the Invention

[0100] A typical available ready to drink tea of the invention isprepared by preparing such tea in the ordinary fashion for such teaand subjecting the tea to a pasteurization process. The componentsof the present invention other than the tea are added thereto (aspowders) under asceptic bottling conditions or alternatively thecomponents of the present invention other than the tea aredissolved in purified, distilled, or filtered water at highconcentrations, subjected to asceptic filtration, and theasceptically filtered solution is added to the pasteurized teaunder asceptic conditions.

EXAMPLE 10

Bottled Juice Drink of the Invention

[0101] A bottled fruit juice of the invention can be prepared bymerely taking an existing fruit juice drink after it has beenpasteurized and fortifying it under asceptic conditions with theinositol hexaphosphate or a mixture of inositol hexaphosphate andinositol and continue to bottle it in appropriate containers underaseptic conditions.

EXAMPLE 11

[0102] Inositol Hexaphosphate and Inositol Enriched Soft and HardDrinks

[0103] Myo-inositol hexaphosphate and myo-inositol in a 1:1 molarratio are added to known bottled soft (including bottled water)and/or hard drinks, including those marketed under various: tradenames including those products made or distributed under variousCocoCola.TM. brands, Aquapure, Aquarius, Bacardi Mixers, BacardiPremium Mixers, Bard's, Barrilitos, Beverly, Bright And Early,caffeine free Barq's, caffeine free Coca-cola, caffeine free Cokelight/Diet Coke, Campbells, Cascal, cherry Coke, Chippewa, Citra,Coca-cola, Coca-Cola Zero, Cumberland Gap, DANNON DASAM, DelawarePunch, diet_Barq's, Diet cherry Coke, Diet Coke/Coca-Cola light,Diet Coke/Coca-Cola light with Lime, diet Fanta, diet Inca Kola,diet Mello Yello/Mello Yello Zero, Diet NESTEA*, diet Vanilla Coke,Dr Pepper, Evian, Fanta, Five Alive, Flavor Rage, Fresca,Fruitopia, FUZE, Georgia, glaceau smart water, glaceau vitaminwater, glaceau vitamin water zero, Gold Peak, H2OK, Hi-C, Honest,Illy*, Inca Kola, Java Monster, Juan Valdez, Krest, Lift, MasterChill, Master Pour, McCafe, Mello Yello, Mezzo Mix, Minute Maid,Minute Maid Enhanced, Minute Maid Juices To Go, Minute Maid SoftDrink, Monster, NESTER*, NESTER COOL*, Northern, Neck, NOS,Odwalla, Peace, Pepe Rico, Pibb, POWERADE, POWERADE LIGHT, POWERADEPLAY, Red Flash, Simply Orange, Smart, Sokenbicha, Southern Sun,Sprite, Sprite Remix, Sprite Zero/diet Sprite/Sprite light,Sunfill, TaB, Vanilla Coke, VAULT, Vegitabeta, Worx, Energy, Zico,all Pepsi brands and Gatorade brands.

[0104] Inositol phosphates and/or analogs described herein areexcellent candidates for chemoprevention due to cell permeability,solubility, low toxicity, and demonstrated efficacies inhibitingtumor growth.

EXAMPLE 12

Genistein Containing Compositions

[0105] Examples 1-11 are repeated except that 1 mg (Example 12a), 5mg (Example 12b), 10 mg (Example 12c), 15 mg (Example 12d), 20 mg(Example 12e), 25 mg (example 12f), 30 mg (Example 12g), 35 mg(Example 12b), 40 mg (Example 12i), 45 mg (Example 12j) or 50 mg(Example 12k) of genistein are added to the compositions. Eachsubpart of Example 12 is to be understood as a repetition of eachof Examples 1-11 with the particular amount of genistein mentionedfor that subpart.

EXAMPLE 13

[0106] 500 mg of myoinositol hexaphosphate and 1.67 gramsmyoinositol, 20 mg's of Genistein were dissolved in 20 oz ofdistilled water to form a drink product of the present invention.The drink product was consumed twice a day.

EXAMPLE 14

[0107] 500 mg of myoinositol hexaphosphate and 1.67 gramsmyoinositol, 20 mg's of Genistein, 200 mgs of pharmaceutical gradewater soluble liposomal encapsulated Ubiquinol(Qunol Liquid Co Q10)(U.S. Pat. No. 6,455,072) were dissolved in 20 oz of distilledwater to form a drink product of the present invention. The drinkproduct was consumed twice a day.

EXAMPLE 15

[0108] 500 mg of myoinositol hexaphosphate and 1.67 gramsmyoinositol, 20 mg's of Genistein, pharmaceutical grade watersoluble liposomal encapsulated Ubiquinol(Qunol Liquid Co Q10) (U.S.Pat. No. 6,455,072) were dissolved in 20 oz of Acai blueberryPomegranate juice to farm a drink product of the present inventionB1 1.1 mg, B5 5 mg B6-1.7 mg, B12-2.4 mcg, ascorbic acid-500 mgtablets were crushed and added to the drink-and the drink productwas consumed twice a day.

[0109] One skilled in the art will readily appreciate that thepresent invention is well adapted to carry out the objectives andobtain the ends and advantages mentioned, as well as those inherenttherein. The embodiments, methods, procedures and techniquesdescribed herein are presently representative of the preferredembodiments, are intended to be exemplary and are not intended aslimitations on the scope. Changes therein and other uses will occurto those skilled in the art which are encompassed within the spiritof the invention and are defined by the scope of the appendedclaims. Although the invention has been described in connectionwith specific preferred embodiments, it should be understood thatthe invention as claimed should not be unduly limited to suchspecific embodiments. Indeed, various modifications of thedescribed modes for carrying out the invention which are obvious tothose skilled in the art are intended to be within the scope of thefollowing claims.

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