The present invention relates to the use of unprocessed hop flowers for preparing a substance for suppressing and preventing the malignant growth of cancer cells, as well as to the use of unprocessed hop flowers for preparing a substance for treating viral and/or bacterial syndromes with a base of substantially natural products. The present invention furthermore relates to tablets and to a method for preparing a composition with a liquid base, in dissolved and/or suspended form, and to the composition thus obtained, which is ingested orally.

Such an anti-cancer substance is known per se from JP- 52-145509-A, wherein hop flowers are dried at an elevated temperature for 5-15 hours until the moisture content has reached a value of 10-20%.

The hop thus dried is then transferred to water and subjected to a temperature treatment at 60-65'C for 1-3 hours and at 90-100 °C for 30-60 seconds.

European patent application No. 0 782 858, which was previously filed by the present applicant, and International patent application WO 98/35686 indeed relate to a substance which contains hop, but said substance is used for an essentially different purpose, viz. stimulating growth, unlike the present therapeutic effect, in particular suppressing and preventing the malignant growth of cancer cells as well as treating viral and/or bacterial syndromes, such as infection with the HIV virus, the herpes virus and Crohn's disease.

Furthermore, RU-2075313-C1 relates to a botanical composition for treating malignant cell growth, which composition comprises linseed, sunflower seeds, sesame seeds or soybean oil in an ethanol emulsion. The use of hop is not known therefrom.

Substances with a vegetable base for suppressing and preventing the growth of malignant cancer cells are known per se and extensively described in US patents Nos. 5,792,503; 5,807,586 and 5,726,034. The substances which are for example disclosed in US patent No. 5,726,034 are based on vegetable materials, in particular soybean.

Soybean is known to include genistein, daidzein and glycithein"families" of isoflavones. The isoflavones present in vegetable proteins, such as soybeans, are known to have medicinal value. It has been reported in particular that genistein and daidzein are capable of suppressing the growth of human cancer cells, such as breast cancer cells and prostate cancer cells. The hitherto known nutrient sources for genistein are foodstuffs prepared from soybeans, such as soybean shoots, tofu (soya cheese) and tempeh. Tempeh is a fermented soybean product. Tofu is reported to contain 87-216 mg of genistein. Beverages with a base of soybean, such as soya milk, contain much less genistein, and baby food prepared with soya milk only contains traces of genistein.

Although the special effect of genistein has not been clarified as yet, it is assumed by the present applicants that genistein, like most isoflavones, exhibits a certain phytoestrogenic activity. After genistein has been introduced into the bloodstream, this substance as such, or via one of its conversion products, will exhibit a biologically active, hormone-like effect in the body. Phytoestrogens, such as genistein and daidzein are partially converted in the intestine into substances exhibiting a weak oestrogenic activity. These substances are assumed to be capable of occupying receptors. Thus tumours which depend on oestrogen for their growth are inhibited. Such tumours may form in the mammary gland, the prostate and the intestine. Epidemiologic studies have shown that the relatively low breast cancer mortality among Asian women is generally ascribed to the phytoestrogenic effects of isoflavones from soya. After all, Asian women daily consume one or more foodstuffs prepared with a base of soya. Accordingly, the concentration of isoflavones in the blood of Asian women is higher than that of Western women. It is thus assumed that the concentrations of genistein and daidzein in Asian women are 100-1000 times higher than those in European women and North-American women.

Although isoflavones exhibit a weak oestrogenic effect, high ingestions thereof may exhibit an effective biological effect. This is of practical significance in particular for menopausal women, who generally exhibit low oestrogen levels. Thus it is assumed that Japanese women run a much lower risk of suffering from hot flashes and other typical menopausal symptoms than Western women.

Now a substance with a natural base has been found, however, which has appeared to have a suppressive and a preventive effect on the malignant growth of cancer cells within a relatively short period of time after ingestion has started. This special effect of the present substance was not known from any of the references, however, nor had it been suggested in scientific literature. Additional studies have furthermore shown that besides providing the aforesaid therapeutic effect, the present substance also appears to be effective in the treatment of viral syndromes, such as infection with the HIV virus and the herpes virus, and bacterial diseases, such as Crohn's disease. Such a novel and inventive therapeutic effect is generally also referred to as being resistance- enhancing or immunostimulating.

The substance according to the present invention is produced as a powdery substance, from which tablets are made or which is dissolved and/or suspended in water by the user and subsequently ingested.

It is also possible, of course, to market the present composition in dissolved/suspended condition.

The present invention thus relates to the use of unprocessed hop flowers for preparing a substance for suppressing and preventing the malignant growth of cancer cells. In addition to that, the present invention relates to the use of unprocessed hop flowers for preparing a substance for the treatment of viral and/or bacterial syndromes.

The term unprocessed hop flowers is understood to mean that the hop flowers have not been subjected to temperature treatments, extraction treatments and the like, which treatments must be considered to be detrimental to the action of the active constituents that are present in hop flowers. Treatments such as grinding and screening are permissible, however, because such treatments do not have an adverse effect on the active constituents in hop flowers. Strobuli Humulus Lupulus is considered to be a suitable hop flower.

Although a substance for stimulating breast development which contains hop is known from European patent application No.

96203204.1, which was already filed in 1996 by the present applicants, it is not known from said European patent application to use a hop flower-

comprising substance for suppressing and preventing the malignant growth of cancer cells, as well as for treating viral and/or bacterial syndromes.

The effect of the substance for suppressing and preventing the malignant growth of cancer cells as well as for treating viral and/or bacterial syndromes can be advanced even further by adding to the substance one or more substances selected from the group of malt, wheat, barley, rye, maize and oat, in particular the nutrient or dietary fibres thereof.

It is preferred to use the above-mentioned agricultural products in their most natural form, viz. in the form wherein the products such as malt, wheat, barley, rye, maize and oat are harvested, that is, the complete grain with the skin. Said fibres restore the intestinal flora and thus contribute to supporting the body's own immune system.

Furthermore, linseed can be added to the present substance, wherein the use of linseed causes the amount of polyunsaturated fatty acids to increase, which thus has a favourable effect on the aforesaid novel and inventive therapeutic effects, in particular in the treatment of viral and/or bacterial syndromes as well as the suppression of malignant growth of cancer cells. Moreover, it has been established that the present substance has a preventative effect with regard to the growth of malignant cancer cells.

In addition, in specific embodiments of the present substance it is desirable to add sunflower seeds, wherein the use of sunflower seeds leads to an enhanced concentration of phosphorus in the present substance. It is assumed that phosphorus is an essential constituent in the metabolism of fats and starch. In addition, phosphorus is necessary for the assimilation of niacin, which niacin is water-soluble and which is often referred to as B3. B3 is in particular important for the synthesis of sex hormones and of cortisone, thyroxin and insulin.

In order to mask the slightly bitter taste of the present mixture, it is advisable to add flavourings, in particular flavourings which are known in connection with the preparation of instant pudding or the like having different tastes, for example. According to one embodiment, however, it is possible to form the present substance solely of unprocessed hop flowers as the active constituent as described

before, although the taste will not be found to be pleasant or tasty, which embodiment will be explained in the examples hereinafter.

Experiments have shown that 1000 g of the present substance preferably contain 100-500 g of unprocessed hop flowers and 100-800 g of the sum of one or more of the ingredients malt, wheat, barley, maize, rey and oat, with the balance of the amount of 1000 g possibly consisting of linseed, sunflower seeds and/or flavourings.

Preferably, about 4-5 level teaspoonfuls (about 10- 15 g) of the present substance mixed with about 100 ml of water are ingested after stirring. It is advisable to drink about 1.5 1 of water with a daily dose of 15 tablets. When a daily dose of this composition is taken, a reduction of the size of the malignant cancer cells can be observed after about 6 months already. After about 2 months the growth of the malignant cells will be stopped or in any case retarded. It has become apparent that when no malignant cells are developed any more, the present substance exhibits a preventive effect.

The present invention will now be explained by means of a number of examples, which examples are only given by way of illustration and which should not be considered to be limitative in any way.

Example 1.

An amount of 200 g of unprocessed hop flowers is mixed with 20 g of an inert material, viz. starch, which functions as a carrier.

The mixture is transferred to 100 ml of water, after which the composition thus obtained is orally ingested in daily amounts corresponding to 2 g of active constituent, viz. unprocessed hop flowers. The treatment was carried out for a period of four weeks, and after two weeks already a reduction of the size of the lumps in the breasts could be observed.

Example 2.

300 g of unprocessed hop flowers are mixed with 100 g of maize, 100 g of barley, 100 g of malt, 100 g of linseed, 100 g of sunflower seeds and 100 g of wheat, with the cereals being fully composed cereals, that is, including the skin, to which 200 of rye are added. Then this mixture is further mixed with 80 g of oats and 20 g of starch, which functions as a carrier.

Following homogeneous mixing of the materials, 5 g of the substance thus formed are suspended in 100 ml of water and stirred thoroughly. Then the composition is ingested. After ingestion of the substance once a day for one month, a preventive effect as regards the development of malignant cancer cells is already manifested, in particular in female breasts.

Example 3.

The composition of example 2 was prepared, using 5 g of oats, 5 g of maize and 70 g of flavourings, viz. raspberry flavour instant pudding powder, instead of 80 g of oats, however. The effect is similar to that observed in Example 2, but the substance is found to be tastier when ingested orally as a powder suspended in water.

Example 4.

140 g of rye, 140 g of wheat, 140 g of malt, 140 g of oats, 140 g of maize and 100 g of barley are mixed, to which mixture 400 g of unprocessed hop flowers are added.

Following intensive mixing of these materials combined with auxiliary materials, thus obtaining a homogeneous mixture of 1200 g of active constituents, 1200 tablets having a weight of about 1.2 g per tablet are formed thereof.

After being ingested in an amount of 10 tablets per day for a period of 60 days, these tablets provide an intended result, in particular with regard to the reduction of the malignant growth of cancer cells in female breasts.

Comparative example.

The composition according to example 1 was prepared, with this exception that hop treated in accordance with JP-52-145509-A was used. Therapeutic treatment of malignant cancer cells with an amount of substance corresponding to 2 g of processed hop for a period of 10 weeks resulted in a barely noticeable reduction in the size of the lumps in the breasts of the test persons. This seems to indicate that the heating of the hop flowers has reduced the amount of active constituents to such a level that a non-active substance is obtained.

Example 5.

The composition according to example 1 was used with patients infected with the HIV virus. The amount of virus-infected cells

decreased considerably within 6 weeks after the daily ingestion of 8- 11 g of active constituent was started.

Example 6.

The composition according to example 1 was used, with this exception that no oats, rye or starch were added. The composition thus prepared was administered orally to patient's having Crohn's disease, using the same dose as in example 2. After a period of 2 weeks already a significant alleviation of the test persons'symptoms was observed.