Abstract:
The present invention features a novel use of processed ingredients from the Indian mulberry plant. More specifically, the present invention features a novel use of processed  Morinda citrifolia , namely  Morinda citrifolia  fruit juice, puree, or puree juice for treating breast cancer, and particularly for inhibiting and/or preventing the metastasis of carcinogenic cells within the mammary region of the breast, as well as destroying metastasized mammary or breast cancer cells. The present invention comprises the consumption of food products or medicinal products or compositions comprising processed  Morinda citrifolia , in either puree or fruit juice form. The present invention also features a method of inhibiting carcinogen-mediated conversion of mammary cells and protecting DNA against carcinogen-mediated damage by administering a composition comprising water soluble  Morinda citrifolia.

Description:
RELATED APPLICATIONS  
       [0001]     This application claims priority to U.S. Provisional Application Ser. No. 60/403,154, filed Aug. 12, 2002, entitled, “Preventative Effect of  Morinda citrifolia  on Mammary Breast Cancer.” 
     
    
     BACKGROUND  
       [0002]     1. Field of the Invention  
         [0003]     The present invention relates to medicinal products, as well as to health and wellness food products, and particularly to a medicinal product or a health and wellness food product designed to inhibit, block, and prevent further growth of carcinogenic cells, as well as to destroy existing carcinogenic cells, within the mammary region of the breast. Stated differently, the present invention relates to inhibiting, blocking, and preventative methods of treatment for mammary breast cancer.  
         [0004]     2. Background of the Invention and Related Art  
         [0005]     Thousands of Americans are diagnosed with breast cancer each year. In the U.S. in 2002, it was estimated that more than 255,000 women and 1500 men were diagnosed and nearly 40,000 women and 400 men died from the disease. Treatment protocols for breast cancer are much the same as those for other types of cancer. Such methods include surgery, radiation therapy, chemotherapy and hormone therapy.  
         [0006]     Whereas surgery is often used as a last resort, radiation therapy, chemotherapy and/or hormone therapy may be implemented at any stage of breast cancer to inhibit and/or destroy malignant tumor growth. Although such cytotoxic treatments are often highly successful, such treatments also destroy substantial numbers of healthy cells and, particularly in the case of hormone therapy, may actually increase a patient&#39;s chances of developing other types of cancer. Some of the side effects typically experienced by those undergoing traditional breast cancer treatment include nausea, diarrhea, hair loss, and hypersensitivity to light, and weight loss. These debilitating side effects limit the frequency and dosage at which such treatments may be administered, thereby limiting the perceived effect of the treatment and requiring longer periods of such treatment over time.  
         [0007]     Accordingly, what is needed is a non-invasive method for inhibiting tumor growth in breast cancer patients that does not cause ancillary debilitating sickness. What is also needed is a method for inhibiting mammary tumor growth that limits ancillary weight loss. Finally what is needed is a compound having an anti-tumorigenesis effect that may be aggressively administered over a relatively short period of time to effectively inhibit and/or destroy tumor growth within that period of time without causing harmful side effects.  
         [0008]     Such methods and compounds are claimed herein.  
       SUMMARY AND OBJECTS OF THE INVENTION  
       [0009]     The present invention teaches the administration of compounds containing an effective amount of  Morinda citrifolia  fruit juice, puree or puree juice to inhibit the conversion of mammary cells to tumors. In one embodiment, the invention is a method of inhibiting mammary tumor growth in a mammal, comprising administering to the mammal a tumor-inhibitory amount of a  Morinda citrifolia  product selected from the group consisting of  Morinda citrifolia  fruit juice,  Morinda citrifolia  puree and  Morinda citrifolia  puree juice. Other embodiments of the present invention comprise a non-toxic compound having an anti-tumorigenesis effect, wherein the non-toxic compound comprises an effective amount of  Morinda citrifolia  product selected from the group consisting of  Morinda citrifolia  fruit juice,  Morinda citrifolia  puree and  Morinda citrifolia  puree juice; and Methyl Sulfonyl Methane. Certain other embodiments of the present invention comprise a method for treating mammary breast cancer comprising adding a processed  Morinda citrifolia  product to an alcohol-based solution; isolating and extracting an active ingredient of the  Morinda citrifolia  product from the solution, and exposing the active ingredient to an area afflicted by one or more carcinogenic cells, thereby inhibiting, preventing, and/or destroying the growth of the carcinogenic cells.  
         [0010]     An object of the present invention is to provide a non-invasive method for inhibiting tumor growth in breast cancer patients that does not cause ancillary debilitating sickness.  
         [0011]     Another object of the present invention is to provide a method for inhibiting mammary tumor growth that limits ancillary weight loss.  
         [0012]     A further object of the present invention is to provide a compound having an anti-tumorigenesis effect that may be aggressively administered over a relatively short period of time to effectively inhibit and/or destroy tumor growth within that period of time without causing harmful side effects.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0013]     In order that the manner in which the above recited and other features and advantages of the present invention are obtained, a more particular description of the invention will be rendered by reference to specific embodiments thereof, which are illustrated in the appended drawings. Understanding that the drawings depict only typical embodiments of the present invention and are not, therefore, to be considered as limiting the scope of the invention, the present invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:  
         [0014]      FIG. 1  is a graphical representation of the effectiveness of certain  Morinda citrifolia -containing compounds on the prevalence of tumors in accordance with the present invention;  
         [0015]      FIG. 2  is a graphical representation of the preventive effects of  Morinda citrifolia -containing compounds on mammary gland tumorigenesis induced by estrogen in female ACI rats in accordance with the present invention;  
         [0016]      FIG. 3  is a graphical representation of the relative body weight of rats that have been implanted with estrogen to induce tumorigenesis, wherein certain rats have been treated with  Morinda citrifolia -containing compounds to counteract the effects estrogen-induced tumorigenesis in accordance with the present invention;  
         [0017]      FIG. 4  is a graphical representation of the relative size of tumors in rats treated with various compounds; and  
         [0018]      FIG. 5  is a graphical representation of the conversion of Dimethyl Sulfoxide to Methyl Sulfonyl Methane in accordance with certain embodiments of the present invention.  
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0019]     It will be readily understood that the components of the present invention, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of the embodiments of the system and method of the present invention is not intended to limit the scope of the invention, as claimed, but is merely representative of the presently preferred embodiments of the invention.  
         [0020]     The present invention describes a method for treating breast cancer, and particularly to the inhibition, blocking, and/or prevention of cancerous cell growth within the mammary region of the breast, as well as a method and formulation for destroying existing cancerous cells within the breast using a formulation comprising  Morinda citrifolia  in processed form.  
         [0021]     The following detailed description is separated into sections to more clearly point out and present the advantages and aspects of the present invention. A general description of  Morinda citrifolia , including its origins, processing techniques, and health benefits is explained below, followed by a more detailed description of the  Morinda citrifolia -based formulations and compositions used to treat breast cancer, including examples of experimental studies and the results attained.  
       General Description of  Morinda Citrifolia    
       [0022]     The Indian Mulberry or Noni plant, known scientifically as Morinda Citrifolia L. ( Morinda citrifolia ), is a shrub or small tree up to 10 m in height. The leaves are oppositely arranged with an elliptic to ovate form. The small white flowers are contained in a fleshy, globose, head-like cluster. The fruits are large, fleshy, and ovoid. At maturity, they are creamy-white and edible, but have an unpleasant taste and odor. The plant is native to Southeast Asia and has spread in early times to a vast area from India to eastern Polynesia. It grows randomly in the wild, and it has been cultivated in plantations and small individual growing plots. The  Morinda citrifolia  flowers are small, white, three to five lobed, tubular, fragrant, and about 1.25 cm long. The flowers develop into compound fruits composed of many small drupes fused into an ovoid, ellipsoid or roundish, lumpy body, with waxy, white, or greenish-white or yellowish, semi-translucent skin. The fruit contains “eyes” on its surface, similar to a potato. The fruit is juicy, bitter, dull-yellow or yellowish-white, and contains numerous red-brown, hard, oblong-triangular, winged 2-celled stones, each containing four seeds.  
         [0023]     When fully ripe, the fruit has a pronounced odor like rancid cheese. Although the fruit has been eaten by several nationalities as food, the most common use of the  Morinda citrifolia  plant was as a red and yellow dye source. Recently, there has been an interest in the nutritional and health benefits of the  Morinda citrifolia  plant, further discussed below.  
         [0024]     Because the  Morinda citrifolia  fruit is for all practical purposes inedible, the fruit must be processed in order to make it palatable for human consumption and included in food products used to treat Candidiasis. Processed  Morinda citrifolia  fruit juice can be prepared by separating seeds and peels from the juice and pulp of a ripened  Morinda citrifolia  fruit; filtering the pulp from the juice; and packaging the juice. Alternatively, rather than packaging the juice, the juice can be immediately included as an ingredient in another food product, frozen or pasteurized. In some embodiments, the juice and pulp can be pureed into a homogenous blend to be mixed with other ingredients. Other process include freeze drying the fruit and juice. The fruit and juice can be reconstituted during production of the final juice product. Still other processes include air drying the fruit and juices, prior to being masticated.  
         [0025]     The present invention utilizes the fruit juice and the oil extracted from the  Morinda Citrifolia  plant. In a currently preferred process of producing  Morinda citrifolia  fruit juice, the fruit is either hand picked or picked by mechanical equipment. The fruit can be harvested when it is at least one inch (2-3 cm) and up to 12 inches (24-36 cm) in diameter. The fruit preferably has a color ranging from a dark green through a yellow-green up to a white color, and gradations of color in between. The fruit is thoroughly cleaned after harvesting and before any processing occurs.  
         [0026]     The fruit is allowed to ripen or age from 0 to 14 days, with most fruit being held from 2 to 3 days. The fruit is ripened or aged by being placed on equipment so it does not contact the ground. It is preferably covered with a cloth or netting material during aging, but can be aged without being covered. When ready for further processing the fruit is light in color, from a light green, light yellow, white or translucent color. The fruit is inspected for spoilage or for excessively green color and hard firmness. Spoiled and hard green fruit is separated from the acceptable fruit.  
         [0027]     The ripened and aged fruit is preferably placed in plastic lined containers for further processing and transport. The containers of aged fruit can be held from 0 to 30 days. Most fruit containers are held for 7 to 14 days before processing. The containers can optionally be stored under refrigerated conditions prior to further processing. The fruit is unpacked from the storage containers and is processed through a manual or mechanical separator. The seeds and peel are separated from the juice and pulp.  
         [0028]     The juice and pulp can be packaged into containers for storage and transport. Alternatively, the juice and pulp can be immediately processed into finished juice product. The containers can be stored in refrigerated, frozen, or room temperature conditions. The  Morinda citrifolia  juice and puree are preferably blended in a homogenous blend, after which they may be mixed with other ingredients, such as flavorings, sweeteners, nutritional ingredients, botanicals, and colorings. The finished juice product is preferably heated and pasteurized at a minimum temperature of 181° F. (83° C.) or higher up to 212° F. (100° C.).  
         [0029]     The product is filled and sealed into a final container of plastic, glass, or another suitable material that can withstand the processing temperatures. The containers are maintained at the filling temperature or may be cooled rapidly and then placed in a shipping container. The shipping containers are preferably wrapped with a material and in a manner to maintain or control the temperature of the product in the final containers.  
         [0030]     The juice and pulp may be further processed by separating the pulp from the juice through filtering equipment. The filtering equipment preferably consists of, but is not limited to, a centrifuge decanter, a screen filter with a size from I micron up to 2000 microns, more preferably less than 500 microns, a filter press, reverse osmosis filtration., and any other standard commercial filtration devices. The operating filter pressure preferably ranges from 0.1 psig up to about 1000 psig. The flow rate preferably ranges from 0.1 g.p.m. up to 1000 g.p.m., and more preferably between 5 and 50 g.p.m. The wet pulp is washed and filtered at least once and up to 10 times to remove any juice from the pulp. The wet pulp typically has a fiber content of 10 to 40 percent by weight. The wet pulp is preferably pasteurized at a temperature of 181° F. (83° C.) minimum and then packed in drums for further processing or made into a high fiber product.  
         [0031]     The method for extracting and processing the oil is described in co-pending application Ser. No. 09/384,785, filed on Aug. 27, 1999, which is incorporated by reference herein. The  Morinda citrifolia  oil typically includes a mixture of several different fatty acids as triglycerides, such as palmitic, stearic, oleic, and linoleic fatty acids, and other fatty acids present in lesser quantities. In addition, the oil preferably includes an antioxidant to inhibit spoilage of the oil. Conventional food grade antioxidants are preferably used.  
         [0032]     The  Morinda citrifolia  plant is rich in natural ingredients. Those ingredients that have been discovered include: from the leaves: alanine, anthraquinones, arginine, ascorbic acid, aspartic acid, calcium, beta-carotene, cysteine, cystine, glycine, glutamic acid, glycosides, histidine, iron, leucine, isoleucine, methionine, niacin, phenylalanine, phosphorus, proline, resins, riboflavin, serine, beta-sitosterol, thiamine, threonine, tryptophan, tyrosine, ursolic acid, and valine; from the flowers: acacetin-7-o-beta-d(+)-glucopyranoside, 5,7-dimethyl-apigenin-4′-o-beta-d(+)-galactopyranoside, and 6,8-dimethoxy-3-methylanthraquinone-1-o-beta-rhamnosyl-glucopyranoside; from the fruit: acetic acid, asperuloside, butanoic acid, benzoic acid, benzyl alcohol, 1-butanol, caprylic acid, decanoic acid, (E)-6-dodeceno-gamma-lactone, (Z,Z,Z)-8,11,14-eicosatrienoic acid, elaidic acid, ethyl decanoate, ethyl hexanoate, ethyl octanoate, ethyl palmitate, (Z)-6-(ethylthiomethyl) benzene, eugenol, glucose, heptanoic acid, 2-heptanone, hexanal, hexanamide, hexanedioic acid, hexanoic acid (hexoic acid), 1-hexanol, 3-hydroxy-2-butanone, lauric acid, limonene, linoleic acid, 2-methylbutanoic acid, 3-methyl-2-buten-1-ol, 3-methyl-3-buten-1-ol, methyl decanoate, methyl elaidate, methyl hexanoate, methyl 3-methylthio-propanoate, methyl octanoate, methyl oleate, methyl palmitate, 2-methylpropanoic acid, 3-methylthiopropanoic acid, myristic acid, nonanoic acid, octanoic acid (octoic acid), oleic acid, palmitic acid, potassium, scopoletin, undecanoic acid, (Z,Z)-2,5-undecadien-1-ol, and vomifol; from the roots: anthraquinones, asperuloside (rubichloric acid), damnacanthal, glycosides, morindadiol, morindine, morindone, mucilaginous matter, nor-damnacanthal, rubiadin, rubiadin monomethyl ether, resins, soranjidiol, sterols, and trihydroxymethyl anthraquinone-monomethyl ether; from the root bark: alizarin, chlororubin, glycosides (pentose, hexose), morindadiol, morindanigrine, morindine, morindone, resinous matter, rubiadin monomethyl ether, and soranjidiol; from the wood: anthragallol-2,3-dimethylether; from the tissue culture: damnacanthal, lucidin, lucidin-3-primeveroside, and morindone-6beta-primeveroside; from the plant: alizarin, alizarin-alpha-methyl ether, anthraquinones, asperuloside, hexanoic acid, morindadiol, morindone, morindogenin, octanoic acid, and ursolic acid.  
       Present Invention Compositions or Formulations and Methods of Administration  
       [0033]     The following formulations represent some of the preferred formulations contemplated by the present invention.  
                                                                                                                                   Ingredients   Percent by Weight                                    Formulation One                  Morinda citrfolia  Fruit Juice   100%            Formulation Two                  Morinda citrfolia  Fruit Juice    85-99.99%           Water   0.1-15%            Formulation Three                  Morinda citrifolia  Fruit Juice    85-99.99%           Other fruit juices   0.1-15%            Formulation Four                  Morinda citrifolia  Fruit Juice    50-90%           Water   0.1-50%           Other fruit juices   0.1-30%                      
 
         [0034]     In one preferred method, a person suffering from mammary breast cancer as described above takes at least one (1) ounce of Formulation One in the morning on an empty stomach, and at least one (1) ounce at night on an empty stomach, just prior to retiring to bed. In one example, which is not meant to be limiting in any way, the beneficial  Morinda Citrifolia  is processed into Tahitian Noni® juice manufactured by Morinda, Incorporated of Orem, Utah.  
         [0035]     In another preferred embodiment, a person diagnosed with or experiencing symptoms of breast cancer takes at least one ounce of Formulation Two twice a day until the overgrowth is abated.  
         [0036]     The following examples set forth and present the effects of  Morinda citrifolia  on carcinogenic cells within the mammary or breast region. These examples are not intended to be limiting in any way, but are merely illustrative of the beneficial, advantageous, and remedial effects of  Morinda citrifolia  on carcinogenic cells within the mammary or breast. Other non-limiting examples of the present invention are described below.  
       EXAMPLE ONE  
       [0037]     In the present example, a patient experiencing or diagnosed with and is suffering from mammary breast cancer desires to treat the condition with a nonprescription, over-the-counter preparation. To treat the cancer, the individual consumes an identified prescribed amount of a food product composition containing processed  Morinda citrifolia  fruit juice. The person intermittently consumes the food product containing the processed  Morinda citrifolia  fruit juice until the carcinogenic cells within the mammary are inhibited, blocked, and/or destroyed, wherein the infection is reduced or eliminated.  
       EXAMPLE TWO  
     Effect of  Morinda Citrifolia -Containing Compounds on DMBA-Induced Mammary Tumors  
       [0038]     Experimental Conditions:  
         [0039]     Female SD rats were exposed to DMBA to induce tumors. In one experiment, 10 percent  Morinda Citrifolia  Juice in drinking water for seven days was able to completely prevent DNBA-DNA adduct formation associated with breast cancer. Indeed, no benign or malignant tumors were detected, with only mild hyperplasia present in some rats.  
         [0040]     In a second experiment, the female rats were once again induced with DMBA eight months prior to administration of 5 percent  Morinda Citrifolia  juice in drinking water for 90 days. After sacrifice, the rats revealed no mammary breast cancer at all.  
       EXAMPLE THREE  
     Effect of  Morinda Citrifolia -Containing Compounds on E2-Induced Mammary Tumors  
       [0041]     Sixty five-week old female rats were divided into four groups of fifteen rats each and placed on regular diets. Another eight female rats served as age-matched controls. One group of experimental rats was given 5% placebo in drinking water, the second experimental group was given 5%  Morinda citrifolia  juice in drinking water, the third experimental group was given 5% Methyl Sulfonyl Methane (“MSM”) in drinking water, and the fourth experimental group was given a combination of 5%  Morinda citrifolia  juice and 5% MSM in drinking water. Each experimental group was provided with its respective formulation for ninety days following estrogen (E2) implantation. Two weeks later, all animals were implanted subcutaneously with a 25 mg pellet containing 22.5 mg of 17β-estradiol (E2) mixed with 2.5 mg cholesterol. The age-matched control animals received a 25 mg cholesterol pellet implant.  
         [0042]     As seen in  FIGS. 1-4 , the animals in the placebo group had a significant body weight loss when compared to the cholesterol control group. The animals in the  Morinda citrifolia  group or MSM group had slight body weight loss. None of the rats that received the pellets composed of cholesterol exhibited mammary tumors. All rats with an E2 implant in the placebo group had mammary gland tumors. One hundred percent (100%) of the rats in this group had three to seven tumors. Seventy-one percent (71%) of the rats in the  Morinda citrifolia  group had two to five tumors. Fifty-seven percent (57%) of the rats in the MSM group had one to four tumors. Forty-three percent (43%) of the rats in the combination group had zero to three tumors.  
         [0043]     The average tumor area in the placebo group,  Morinda citrifolia  group, MSM group, and combination group at 180 days after E2 implantation were 17, 12, 10 and 6 mm2, respectively. The survival rates of the control, placebo,  Morinda citrifolia , MSM and combination groups one hundred and sixty days after E2 implantation were 100%, 0%, 47%, 73%, and 87%, respectively. The survival rates of the groups at one hundred eighty days after E2 implantation was 100%, 0%, 0%, 20% and 60%, respectively. At two hundred days, the survival rates were 100%, 0%, 0%, 0%, and 27%, respectively.  
         [0044]     The present invention may be embodied in other specific forms without departing from its spirit of essential characteristics. The described embodiments are to be considered in all respects only al illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims, rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.