WO2008054293A1 - Composition, utilisation de ladite composition pour le traitement de maladies et d'états systémiques, et produit contenant ladite composition - Google Patents

Composition, utilisation de ladite composition pour le traitement de maladies et d'états systémiques, et produit contenant ladite composition Download PDF

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WO2008054293A1
WO2008054293A1 PCT/SE2007/000970 SE2007000970W WO2008054293A1 WO 2008054293 A1 WO2008054293 A1 WO 2008054293A1 SE 2007000970 W SE2007000970 W SE 2007000970W WO 2008054293 A1 WO2008054293 A1 WO 2008054293A1
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composition
composition according
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PCT/SE2007/000970
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Ragnvald Erik Lindblom
Jonas Erik Lindblom
Johan De Faire
Jirawat Janchanakit
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Salutary Care Limited
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/555—Heterocyclic compounds containing heavy metals, e.g. hemin, hematin, melarsoprol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A61K35/741—Probiotics
    • A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/90—Smilacaceae (Catbrier family), e.g. greenbrier or sarsaparilla
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482—Serine endopeptidases (3.4.21)
    • A61K38/4826—Trypsin (3.4.21.4) Chymotrypsin (3.4.21.1)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482—Serine endopeptidases (3.4.21)
    • A61K38/486—Elastase (3.4.21.36 or 3.4.21.37)

Definitions

  • the present invention relates to a pharmaceutical composition according to claim 1 and 4, to the use according to claim 9 and 13 and to a product according to claim 17.
  • a healthy body is dependent on certain basic systemic functions, such as the intestinal tract, immune system and scavenging and removal of cellular by-products, debris and toxic matters .
  • the intestinal tract is not only a system for digestion of foodstuff into nutrients but it is also closely related to certain immune functions, such as the lymphoid immune system known as Peyer's Patches.
  • Peyer's Patches appear as oval or round lymphoid follicles located to the mucosa and extending into the submucosa of the ileum. B-lymphocytes predominate in the follicles' germinal centres and T-lymphocytes are found in the zones between the follicles. Peyer's Patches act as immune surveillance of the intestinal lumen and generate the immune response within the mucosa. Pathogenic microbes and other antigens entering the intestinal tract encounter macrophages, dendritic cells, B- and T-lymphocytes found in Peyer's Patches and other gut associated lymphoid tissue.
  • stem cells migrate to the intestine and Peyer's Patches for programming into specific immune cells, e.g. T- and B- cells, T-helper cells, Killer cells, Memory cells and macrophages.
  • specific immune cells e.g. T- and B- cells, T-helper cells, Killer cells, Memory cells and macrophages.
  • An intestine in balance interacts with the
  • Certain clinical conditions may cause severe disturbances to and malfunctions of vital systemic functions, e.g. intestinal functions, immune responses, removal of antigens, debris and toxins from body tissues and organs.
  • vital systemic functions e.g. intestinal functions, immune responses, removal of antigens, debris and toxins from body tissues and organs.
  • Primary causes of such disturbances and malfunctions may be microbial and viral infections, inflammations, tissue damages and tumour diseases as well as side effects from drug therapies and psychosocial influences.
  • such primary causes may lead to numerous secondary clinical conditions of transient and/or chronic nature, such as rheumatoid arthritis, ulcerous colitis, Crohn's disease, Irritable Bowel Syndrome, Multiple Sclerosis, cancerous diseases, diarrhoea and constipation, opportunistic infections, immune deficiencies, food intolerances and allergies, stasis wounds, autoimmune diseases etc.
  • Digestive tract and its functions i.e. from mouth cavity to large intestine, have been found to be of uttermost importance to this invention as it constitutes a central function for the supply of nutrients and other metabolites and catabolites that are required for syntheses and biochemical reactions for systemic functions and systems, such as maintaining mucosa layers, recovery of essential substances and leaking of stimuli to the immune system to enable formation of antibodies and for programming stem cells into specific immune cells.
  • a malfunctioning and disturbed digestive tract may yield insufficiently digested, converted or transformed nutrients, metabolites, catabolites etc., i.e. they are not fully recognisable by cells or useful for biological syntheses and biochemical reactions. This may lead to an overload of non- recognisable/non-useful substances, i.e. regarded by the immune system as constituting antigens, debris and toxins to be neutralised by the immune system and finally discarded by liver and kidney functions.
  • a healthy body most often recovers from transient episodes of a malfunction/ disturbance to the tract but if protracted antigen, debris and toxins can be accumulated in the body tissues and fluids. Finally, the immune system will be impoverished by the overload and become less responsive leading amongst other to clinical conditions.
  • the microbial contents of the intestine is to digest and convert foodstuff into nutrients and other essential substances for biological syntheses and reactions of the body.
  • the microbial cells are merely "factories" that excrete a cascade of bioactive organic substances rather than converting the foodstuff themselves .
  • bioactive substances are enzymes, organic acids, hormones, bacteriocins and more that create optimal conditions for the survival and proliferation of each strain of the microflora. Also, such created conditions are optimised for all enzymatic activities that are responsible for amongst other the breakdown and conversion of foodstuff.
  • This cascade of bioactive substances may be different from strain to strain as the optimal conditions are different for each strain and for each enzyme. Disturbances to the microbial balance of the intestine may lead to accumulation of antigens, debris and toxin in organs, tissues and body fluids, as well as inflammations, mild to severe clinical primary and secondary conditions not only of the intestines but also to related systems and functions, such as enzymatic/catalytic spectrum, programming of stem cells into T- and B-cells, erythrocytes and other specialised cells, Peyer's Patches, liver and kidney performance.
  • Enzymes and catalytic activities originating from amongst other the intestinal flora and immune cells are believed to be as essential to this invention as a functional intestine.
  • the full mechanism of interaction between the intestine, lymphoid immune system and other immune functions as well as scavenging of the body from antigens, debris, by-products, toxins, free radicals etc. is not absolutely clear.
  • Enzymes and catalytic activities are very basic and essential in all life-forms in the vegetable and animal kingdoms.
  • Early evolved life forms such as prokaryotic cells, like bacteria, to eukaryotic cells in warm-blooded species all are utterly dependent on enzymatic and catalytic activities for their metabolism, communication, defence, survival and multiplication.
  • Enzymes are part of virtually all catalytic processes in biological systems, such as replicating RNA-sequences, digesting foodstuff into nutrients, configuring and transforming organic sequences, substances and precursors into useful reagents and to act as an immunological defence against amongst other cancer cells, e.g. the complement system.
  • phytotrophs can accumulate energy from light and certain enzymes may convert this energy into chemical-bond energy.
  • chemotrophs collect free energy derived from the digestion of food and enzymes convert this energy into chemical-bond ATP, adenosine tri-phosphate. This ATP energy is then used for mechanical energy, such as muscular contraction, and to transport molecules and ions against chemical and electrical gradients .
  • Species in the early phases of the evolution such as monocellular life forms and species with lymphatic and/or with lymphatic and early blood systems as well as certain plants, seem to have enzymes of a more multifunctional nature than what is found in more sophisticated warm-blooded species, like mammals.
  • the multi-functionality may pertain to a more limited number of required catalytic activities and that these activities are closely related but also to the relative simplicity of these early species in which for instance food digestion is an integral part of immunological scavenging for foreign intruders and debris.
  • Such enzymes can be given a variety of chemical/biochemical catalytic activities and biological properties dependent on modification of configuration parameters and formulation procedures. Such modifications seem to diversify the clinical responses of the specific enzyme formulations such as specific targeting of viral host cells, infectious cells, pathogenic bacteria and fungi, inflammatory cells, tumour cells or pain mediators as well as malfunctioning and dead cells.
  • the basic enzyme structure gives the enzyme its basic or preferential enzymatic activity, such as being a trypsin, a galactosidase, a pepsin, a cellulase etc. by in- vitro methods.
  • This basic structure acts as a scaffold onto which other naturally occurring substances from the species itself and added substances/compounds/molecules/ions may bind for several reasons and for multiple purposes. Such reasons and purposes could be to protect the basic structure, to extend or enhance the dynamic recognition function and to configure the basic enzyme for a specific task or function, such as becoming a scavenger, an immune-stimulator (as the enzyme's actions and formed end products increase the chemotactic intensity and other means of intracellular communication), digestive enzyme etc.
  • Carotenoid substances such as astaxanthine are believed to be very essential add-ons in forming the described complexes and their biological properties. It is also believed that these add-ons may form structures similar to micelles, liposome or even cellular-type membranes around the enzymatic scaffold.
  • compositions which are active for restoring certain basic and vital systemic body functions to improve quality of life of persons suffering from severe systemic diseases and conditions.
  • Another object of the present invention relates to the use of the above-mentioned compositions for the manufacturing of a medicine for treatment or prevention the above-mentioned diseases and conditions.
  • a further object of the present invention is to provide a product in the form of dietary supplement, additive, food supplement, functional food, homeopathic and natural medicine, nutraceutical and health product comprising the pharmaceutical compositions .
  • compositions are preferably administrated as a regiment, leading to three biological phases, i.e. cleansing up of accumulated antigens, debris and toxins, building up of intestinal and immune functions and stabilisation at an improved and maintained quality of life level.
  • the regiment has been developed and tested in patients suffering from severe systemic conditions, such as cancerous diseases, HIV/AIDS, chronic inflammations and certain autoimmune diseases, and secondary conditions of such primary diseases, such as bacterial, viral and fungous infections, inflammations, diarrhoea, dehydration, and pain.
  • severe systemic conditions such as cancerous diseases, HIV/AIDS, chronic inflammations and certain autoimmune diseases
  • secondary conditions of such primary diseases such as bacterial, viral and fungous infections, inflammations, diarrhoea, dehydration, and pain.
  • the focus has been to 1) cleanse the system from antigens, debris, toxins and free radicals, 2) to restore the intestinal functions as the very basis of a functional body and 3) leading to a phase of long-term stabilised conditions with no clinical sign of primary and/or secondary symptoms.
  • the two components of the MM-regiment are:
  • Mecosome An catalytic product, named Mecosome, to target malfunctioning cells and to amplify/re-establish chemotactic communication
  • M-Powder A microbial agent , named M-Powder, comprising of well- known and safe microbial strains to restore and maintain a functional intestinal flora.
  • the four components of the MMPM-regiment are:
  • a chemical agent named Mesodine, for cleansing of debris, toxins and scavenging of free radicals of the liver, kidneys, and blood/lymph streams.
  • Mecosome An catalytic product, named Mecosome, to target malfunctioning cells and to amplify/re-establish chemotactic communication
  • M-Powder A microbial agent, named M-Powder, comprising of well- known and safe microbial strains to restore and maintain a functional intestinal flora
  • a herbal component named Phumpat, to stabilise certain elements of the body.
  • the regiments have been evaluated as food/dietary supplement and the components have been administrated orally together with normal food intake.
  • This invention relates to the findings that a composition comprising of a microbial agent and a catalytic product (the MM-regiment) can alleviate, reduce and completely remove secondary conditions and symptoms, such as infections, inflammations, pain, diarrhoea, food intolerances and allergies, incontinence, in patients suffering from mild symptoms to severe systemic disease, such as intestinal infections and inflammations and autoimmune diseases.
  • a composition comprising of a microbial agent and a catalytic product (the MM-regiment) can alleviate, reduce and completely remove secondary conditions and symptoms, such as infections, inflammations, pain, diarrhoea, food intolerances and allergies, incontinence, in patients suffering from mild symptoms to severe systemic disease, such as intestinal infections and inflammations and autoimmune diseases.
  • composition comprising of a microbial agent and a catalytic product further comprising a chemical agent, named Mesodine and a herbal component, named Phumpat (the MMPM-regiment) can alleviate, reduce and completely remove secondary conditions and symptoms, such as infections, inflammations, itching and pain, diarrhoea and dehydration, lipodystrophy, insomnia and tumours, in patients suffering from severe systemic disease, such as HIV/AIDS, cancer and autoimmune diseases.
  • MMPM-regiment the MMPM-regiment
  • the regiments can also remove the primary causes of such systemic diseases.
  • the regiments can reduce side effects and adverse reactions from other therapies and drugs, e.g. HAART, cytostatics, radiation and antiviral, for treating the primary causes and secondary conditions, e.g. antibiotics and antiphlogistics, can be reduced and completely removed and that such therapies and drugs can be re-introduced without recurrence of side effects/adverse reactions when taking the regiment as a concurrent treatment .
  • therapies and drugs e.g. HAART, cytostatics, radiation and antiviral
  • the primary causes and secondary conditions e.g. antibiotics and antiphlogistics
  • the two or four components of the MM- and MMPM regiments respectively can be added to different products in the form of dietary supplement, additive, food supplement, functional food, homeopathic and natural medicine, nutraceutical and health product, i.e. formulations for the general well-being such as vitamins salts, minerals, lipids, microbial cells.
  • Functional food is cheese, yoghurt, cereal and sweets, for instance.
  • the microbial agent, M-Powder is a blend of naturally- occurring and safe strains harvested from soil .
  • Typical composition of M-Powder per gram Pediococcus pentosaceus, 3.5 x 10 4"9 , typically 3 x 10 7 c.f.u;
  • Pichia farinosa 5.5 x 10 4"8 , typically 3 x 10 s c.f.u;
  • -Organic acids such as lactic acid, acetic acid, succinic acid.
  • -Digestive enzymes such as amylase, galactosidase, proteinases, peptidases, lipase, hemicellulase, cellulase, pectinase, and catalase.
  • pediocin bacteriocin
  • -Vitamin B complex and growth factors.
  • Final product is an aluminium sachet filled with 1.5 g of M- Powder .
  • a non-limiting example of a method for obtaining the microbial agent is described below.
  • Topsoil is harvested from a biotope of an annual mean temperature of minimum +16°C during a period when the relative humidity of the topsoil is above 18%.
  • a stock Culture is made from 5 kg of collected soil, 25 kg of soya bean flour, 2 kg of hexose sugar, e.g. mannose . Humidity is adjusted to 25-27% with pure water.
  • the mixture is fermented under aeration, e.g. tumbling, at +32-35°C for 48 hours.
  • a greyish powder is collected and dried at +45 0 C until rest humidity is below 12%, approximately 4 hours.
  • the yield is approx. 27 kg and it can be stored in paper bags in a dark and dry place for maximum 3 months.
  • the product, M-Powder is made from 550 kg of rice bran, 20 kg of soya bean flour and 5 kg of Stock Culture. Humidity is adjusted to 45-47% with pure water. The mixed powder is fermented during 7 days .
  • the fermentation is stopped by drying the product at +45 0 C until the rest • humidity is below 12%.
  • the catalytic product, Mecosome is based on a serine protease extracted and isolated from fish, molluscs and crustacean species.
  • the final product is formulated into a 1 g lozenge containing 1% Mecosome.
  • the basic enzyme is identified as a member of the chymotrypsin/trypsin/elastase family with a molecular weight of 30-32 kDalton by SDS-electrophoresis .
  • Residues of the solvent was removed under vacuum, 30 min. , from the collected water phase before being diluted 2 times, using 50 mM TRIS-HCl, pH 7.4, to ensure a conductivity corresponding to ⁇ 0.1 M NaCl at 22 0 C.
  • This aqueous solution was pumped onto an equilibrated, 50 mM TRIS-HCl, pH 7.4, DEAA Sepharose filled column, (Pharmacia, Sweden) and thereafter rinsed with 3 bed volumes of 50 mM TRIS-HCl, pH 7.4, for the A280 detector to register a baseline 0 -value with regard to protein detection.
  • a gradient desorption procedure was applied using two buffers, i.e. 50 mM TRIS-HCl, pH 7.4 and 1 M NaCL + 50 mM TRIS-HCl, pH 7.4. These buffers were mixed to a linear increase of the NaCl-concentration, from 0 M to 1 M NaCl, over 20 bed volumes. Fractions were collected and measured for tryptic activity using SAAP and/or BAEE as substrates and a standardised spectrophotometrical method was used. Fractions showing tryptic activity were further analysed for molecular size, i.e. SDS- and Native Electrophoresis, isoelectric point, 3.1-3.3, Absorption peak, 273-279 nm and spectrum and other enzymatic activities.
  • Exposure to light Standard fine chemical trypsins showed a successive activity loss to >75% after 2 x 10 hours exposure to subtropical sunlight.
  • Aqueous catalytic products of Mecosome showed an activity increase of up to 10% under identical conditions as above.
  • Oxygenation Aqueous catalytic products of Mecosome showed an activity increase of 12 to 23% after 1 minute's aeration and still after 8 hours' continuous aeration. Aerated samples left to rest for 30 minutes returned to their pre-aeration activity level. The aeration procedure was repeated more than 10 times on the same samples and the increased activity level was repeated each time.
  • Standard fine chemical trypsins showed very quick activity losses, >75%, in minutes to 2 hours, under aeration by an air pump.
  • Aqueous catalytic products of Mecosome stored at - 20, -40 and -9O 0 C were all within the accuracy of the method, i.e. +3%, during the 12-months' test period. Freeze-dried catalytic products, stored at +4 0 C, showed an initial activity loss of 50-80% and no further activity losses could be detected during the test period of 24 months.
  • Aqueous catalytic products of Mecosome stored at +4 0 C showed an activity loss of ⁇ 5% in 35 days and stored at room temperature, +20- +24°C, showed an activity loss of in average 12%, ranging from 8 to 17%, in 12 months.
  • Powder, lozenge, cream, gel and lotion formulations made from aqueous catalytic products of Mecosome showed no activity loss outside the accuracy of the method in 24 months, stored at ambient temperature.
  • Catalytic products were diluted 100 to 400 times in such formulations compared to the purified fractions above.
  • Native electrophoresis shows that the catalytic products start from approx. 60 kDalton and can be greater than 400 kDalton.
  • the protein bands are not necessarily absolute distinct in their appearance but rather like more intensely dyed patches or stains.
  • SDS-electrophoresis i.e. denatured e-phoresis, of the identical fractions shows that the basic tryptic enzyme can be found in all compositions in the mentioned molecular interval .
  • catalytic products vary with regard to their net charges, this is not related to their molecular size, e.g. a larger composition is necessarily not more negatively charged than a smaller composition. Ion-exchange methods can therefore be used to further separate catalytic products as such methods seem not to destroy or damage the compositions.
  • the herbal component, Phumpat is a commercially available herbal remedy, e.g Registration No. G 729/47 with Thai FDA, used for stabilisation of the elements of the body.
  • the final product is formulated into a 500 mg gelatine capsule.
  • a capsule of Phumpat contains : Smilax corbularia kunth Smilax glabra Wall, ex Roxb. Boesenbergia rotunda (L.) Mansf . Albiza procera (Roxb.) Benth Diospyros rhodocalyx Kurz
  • the chemical component, Mesodine is a commercially product, e.g. Registration No.: 12-1-09448-1-0037 with Thai FDA, used for balancing of the body fluids.
  • a capsule of Mesodine contains : L-Glutathion 100,00 mg
  • Vitamin E Complex 5,00 mg Zinc Chelate (as Zinc 1,00 mg) 5,00 mg
  • Mesodine is based on antioxidants, glutathione, ⁇ -lipoic acid and vitamin C and E, that scavenge the liver and kidneys for free radicals, cellular mediators and toxic substances and removes such material from the body system.
  • Antioxidants clear reactive oxygen species, ROS, from the cells. Oxidative stress and ROS-induced alterations of membrane lipids, hyaluronate, essential proteins and DNA are associated Alzheimer's disease, Parkinson's disease, cancer and aging.
  • Antioxidant preparations are used for treating certain inflammations, certain cancers, ischemic conditions as well as for cosmetic products, such as anti-aging and anti-wrinkle products.
  • the final product is formulated into a 520 mg gelatine capsule.
  • MMPM MM
  • M-Powder Mecosome
  • Mecosome Mecosome
  • the present invention typically involves administering the catalytic product in an amount from 0.01 to 10 mg per day, preferably from 0.1 to 1 mg per day, and the microbial agent in an amount from 0.5 to 10 g per day, preferably from 2 to 4 g-
  • the two components of the composition can either be administrated concurrently or non-concurrently.
  • concurrently means that the two components are administrated within 1 hour of each other.
  • the two components MM i.e. the test treatment, were administered orally or topically once to twice a day:
  • M-Powder Three men and two women in early HIV-phase with minor clinical signs of the infection were treated with M-Powder, 2 x 1.5 g per day, and Mecosome Lozenge, 1%, twice per day, for more than 18 months. No antiretroviral therapies were used during this period.
  • Stabilised AIDS-patients Two men and two women who had been treated with MMPM for 10 to 14 months and who had reached stabilised clinical conditions and almost pre-disease quality of life standards, were treated with M-Powder, 2 x 1.5 g per day, and Mecosome Lozenge, 1%, twice per day, for 6 to 11 months. No antiretroviral therapies or other drugs were used during this period.
  • liver metastases were basically gone and only shades of the metastases could be detected by CT scan.
  • Prostate cancer One male suffered from prostate cancer and was in very severe situation. After 4 months on M-Powder and Mecosome Lozenge, standard treatment, he was given a clear bill of health and could go back to his job again. Unfortunately he died 1.5 years later of different reasons.
  • Cholesterol levels stayed between 180 to 220 during a 12 months' period, he regained weight and his joint pain and other related problems decreased to acceptable levels .
  • Rheumatoid arthritis A group of 5 people, aged 55 to 72, with a long medical history of the inflammation, i.e. deformed fingers and other joints, permanent ache/pain, movability disabilities and digestion deficiencies from time to time with severe diarrhoeas .
  • This group includes a large population of all ages and it refers to a short-term treatment of typical symptoms of stomach diseases, food poisoning and tourist diarrhoea.
  • M- Powder 1.5 g was taken twice a day. The onset of the effects was very quick and tummy aches disappeared within 2 hours and no one stayed on the treatment for more than 4 days to fully recover .
  • test persons After 14 days on M-Powder the test persons began to test foodstuff containing lactose and gluten respectively. Two persons from the lactose group and 1 person from the gluten group experienced mild allergy symptoms but after 22 days on M-Powder all test person could eat normal foodstuff without experience food intolerance.
  • M-Powder 1.5 g within 2 to 12 hours from experiencing the typical symptoms of nausea, vomiting, and fever. Stomach pain disappeared within 2 hours and all symptoms faded away in 24 hours, including normal defecation.
  • This group includes more than 40 individuals on a daily maintenance dose of 1.5 g of M-Powder.
  • the group is classified as "otherwise-healthy-people" without any specific clinical symptoms or only minor.
  • the main purpose of this group was to evaluate any possible side effects from the M-Powder treatment as such effects are very unlikely to be observed in other groups with more complex clinical conditions.
  • This group reported subjective assessments of improved health and general well being but no possible or likely side effects or adverse reaction could be observed.
  • the time frame for some of the individuals is more than a year.
  • Gastrointestinal functions were restored in 2-7 days, i.e. diarrhoea stopped and within 1 month abdominal pain, nausea and vomiting stopped as well.
  • Liver dysfunctions such as hepatotoxicity and jaundice, normalised in 1-4 weeks regarding elevated liver enzyme concentrations and yellow discoloration of the skin.
  • Mecosome Lozenge 1 %
  • Mecosome spray 2%
  • the present invention typically involves administering the chemical agent in an amount from 0.1 to 10 g per day, preferably from 0.5 to 4 g per day; the catalytic product in an amount from 0.01 to 10 mg per day, preferably from 0.1 to 1 mg per day; the microbial agent in an amount from 0.5 to 10 g per day, preferably from 2 to 4 g; and the herbal component in an amount from 0.1 to 10 g per day, preferably from 0.5 to 5 gram per day.
  • the four components of the composition can either be administrated concurrently or non-concurrently.
  • concurrently means that the four components are administrated within 1 hour of each other.
  • the four components were administered orally together with food intakes in the morning, midday and evening:
  • Phumpat 2 capsules a 500 mg, Mesodine, 2 capsules a 520 mg, M-Powder, 1 sachet a. 1.5 g, M-Lozenge, 1 lozenge a 1 g.
  • Phumpat 2 capsules a. 500 mg
  • Phumpat 2 capsules a. 500 mg, Mesodine, 2 capsules a 520 mg, M-Powder, 1 sachet a. 1.5 g, M-Lozenge, 1 lozenge a. 1 g.
  • Dehydration was a severe condition in all patients suffering from diarrhoea.
  • the condition stabilised as diarrhoea stopped and was normalised within 7 days based on drinking and urination patterns.
  • Weight gain was approximately 2-4% in the first month for patients with severe diarrhoea and dehydration symptoms. A more moderate but steady weight gain was recorded for all other patients. Patients with pre-treatment eating difficulties, i.e. wounds, blister and soreness of tongue, lips and throat, showed a continued weight loss in the first month but the trend turned as these conditions faded.
  • CD4 counts increased about 40% in about 3 months' time in patients on concurrent antiretroviral therapies and this increase was detectable after approximately 3-4 weeks in to the treatment.
  • CD4 counts in patients on no concurrent antiretroviral therapy showed an initial decrease of about 25% in the first month of treatment and stayed at low levels for the next 3 months. Thereafter, the CD4 counts started to rise and after 4 months, i.e. 8 months in to the treatment, the CD4 counts were above pre-treatment levels. None of the patients showed the expected clinical signs of dropping CD4 levels.
  • Lipodystrophy was assessed to improve by 50% in 4 months with regard to re-distribution of subcutaneous fat from lower trunk/hips to face and arms . After 8 months treatment the skin conditions were more or less normalised and with that also the liver problems related to lipodystrophy. Social life and habits of most patients were affected to various degrees depending much on the pathological phase of the primary condition. Subjective perceptions were dramatic positive changes and improvements of social life situations as conspicuous clinical signs faded and normal habits could be resumed.
  • Pre-MMPM treatment viral load was 8,000.
  • This group includes around 45 patients with side effects/adverse reactions from HAART therapies, antibiotics and anti-inflammatory drugs, such as gastrointestinal, e.g. abdominal pain, diarrhoea, constipation, nausea and vomiting; CNS disorders, e.g. dizziness, insomnia, mood fluctuations, depressions and confusion; renal problems; liver dysfunction, e.g. hepatotoxicity .
  • MMPM was taken for as long as each patient stayed on prescribed medication, i.e. 7 days to 14 months .
  • Gastrointestinal functions were restored in 2-7 days, i.e. diarrhoea stopped and within 1 month abdominal pain, nausea and vomiting stopped as well .
  • Liver dysfunctions such as hepatotoxicity and jaundice, normalised in 1-4 weeks regarding elevated liver enzyme concentrations and yellow discoloration of the skin.
  • test persons served as their own historical controls. There was no change made to any prescribed conventional concurrent therapies or drugs during the test period. All persons were experiencing deterioration conditions in the 6 months prior to the test. The test period was 35 days.
  • test persons served as their own historical controls. There was no change made to any prescribed conventional concurrent therapies or drugs during the test period. All persons were experiencing deterioration conditions in the 6 months prior to the test. The test period was 35 days.
  • test persons served as their own historical controls. There was no change made to any prescribed conventional concurrent therapies or drugs during the test period. All persons were included upon experiencing an episode. The test period was 30 days.
  • Such infections may prevent normal food digestion and destroy the micro flora as well as preventing Peyer's Patches system of the small intestine to properly respond, immunologically.
  • An affected Peyer's Patches system may also cut off the immunological signals between CD4 and CD8 cells and other immune cells as well as affecting the programming of stem cells into functional immune cells.
  • the regiment has been designed to clean up the digestive tract and to restore its basic functions, to target and destroy infected cells and to neutralise and to remove toxic products and free radicals from the liver and kidneys.
  • M-Powder is a consortium of natural and live microbial strains and metabolites from such strains. This stabilised consortium restores the basic functions of the small intestine including the Peyer's Patches.
  • M-Powder may restore and maintain ,the basic functions of the small intestine and Peyer's Patches if taken daily or on a regular basis. If a regular intake of the product is disrupted, pre-treatment symptoms and conditions start to recur after 10 to 14 days. It is therefore suggested that the intestinal flora and functions must be supported as long as the underlying systemic insufficiencies/deficiencies/ malfunctions persist. M-Powder is likely to be one such product.
  • Mecosome is a catalytic product that targets amongst other infected cells and destroys such cells. Hypothetical mode of action is that the catalytic product identifies specific cell surface receptors expressed by malfunctioning cells. Such cells are identified, neutralised and destroyed, including their contents.
  • T-cells and APCs Antigen-Presenting-Cells
  • APCs Antigen-Presenting-Cells
  • Dead erythrocytes are digested from haematomas and bruises.
  • Infections are killed, bacterial, fungus and viral such as Staphylococcus aureus, Candida albicans and Herpes simplex I.
  • the enzyme composition leaves healthy and functional cells intact as can be seen from the development of red and healthy granulation tissue as well as proliferation and migration of dermal cells when treating topical wounds and blisters.
  • Phumpat is a traditional herbal remedy that interacts with the body's natural responses and activities for the purpose of bringing balance and equilibrium to metabolic and protective functions .
  • Mesodine is based on antioxidants, glutathione, ⁇ -lipoic acid and vitamin C and E, that scavenge the liver and kidneys for free radicals, cellular mediators and toxic substances and removes such material from the body system.
  • Antioxidants clear reactive oxygen species, ROS, from the cells. Oxidative stress and ROS-induced alterations of membrane lipids, hyaluronate, essential proteins and DNA are associated with Alzheimer's disease, Parkinson's disease, cancer and aging.
  • Antioxidant preparations are used for treating certain inflammations, certain cancers, ischemic conditions as well as for cosmetic products, such as anti-aging and anti-wrinkle products.
  • a most important consequence of the regiment is the quick onset of effects and that a major part of improved conditions basically happen in the first month. This is important as many patients suffering from severe diseases and conditions most often die from acquired secondary conditions, such as infections and inflammations, that may cause sepsis, high TNF- releases, pulmonary and kidney failures etc. - not from the primary causes.
  • One possible application of a modified regiment may be to focus on treating secondary conditions and symptoms as this is likely to relieve the basic systemic functions from such actions and to let such basic functions target on the primary causes .
  • side effects and adverse reactions from other therapies follow a similar pattern of relief and elimination as for secondary conditions and symptoms using the regiment. Therefore, it is plausible that the intended effects and actions from antiviral and other therapies would be perceived as more effective if certain side effects/adverse reactions could be eliminated or reduced. Improved CD4 counts indicate this possibility.

Abstract

L'invention concerne une composition pharmaceutique utile pour traiter ou prévenir des maladies cancéreuses, le VIH/SIDA, des inflammations chroniques, certaines maladies auto-immunes et des états secondaires de telles maladies principales comme de infections bactériennes, virales et fongiques ; des inflammations, des diarrhées, la déshydratation et la douleur. La composition comprend un produit catalytique (basé sur de la protéase de sérine extraite et isolée d'un poisson, de mollusques et d'espèces de crustacés) nommé Mecosome ; et un agent microbien (comprenant les souches Pediococcus pentosaceus, Pichia farinosa, Dekkera bruxellenesis) nommé poudre M. L'invention concerne également l'utilisation de la composition et d'un produit comprenant la composition. La composition peut comprendre, en outre, un agent chimique nommé Mesodine, et un composant à base de plante nommé Phumpat. L'invention concerne enfin l'utilisation de la dernière composition mentionnée et d'un produit contenant la dernière composition mentionnée.
PCT/SE2007/000970 2006-11-03 2007-11-01 Composition, utilisation de ladite composition pour le traitement de maladies et d'états systémiques, et produit contenant ladite composition WO2008054293A1 (fr)

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SE0602334-5 2006-11-03

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Citations (3)

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WO1995014489A1 (fr) * 1993-11-22 1995-06-01 Phairson Medical Inc. Composition comprenant des composes utilises comme agent therapeutique
WO1997029645A1 (fr) * 1996-02-14 1997-08-21 Biofeed (Thailand) Co., Ltd. Aliment pour animaux
US6030612A (en) * 1994-11-22 2000-02-29 Phairson Medical Inc. Antimicrobial uses of multifunctional enzyme

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US6030612A (en) * 1994-11-22 2000-02-29 Phairson Medical Inc. Antimicrobial uses of multifunctional enzyme
WO1997029645A1 (fr) * 1996-02-14 1997-08-21 Biofeed (Thailand) Co., Ltd. Aliment pour animaux

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Publication number Priority date Publication date Assignee Title
US20140186318A1 (en) * 2012-09-14 2014-07-03 Case Western Reserve University Probiotic controlling fungi and uses thereof
US9987316B2 (en) * 2012-09-14 2018-06-05 Case Western Reserve University Probiotic controlling fungi and uses thereof

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