Title of Invention

RUTAPHOS

Abstract

Cancer is a major health problem among men and women worldwide and the incidence is continuously increasing in industrialized nations. During the last two decades extensive basic and clinical research for diagnosis and treatment of several type of cancers have altered the outcome of the disease. However, it remains one of the leading causes of death in humans. Although conventional chemotherapies have traditionally been used to treat patients with various types of cancer, their side-effects and damage to normal cells have been of great concern. Blood forming bone marrow cells are the first to be adversely affected, leading to a decline in the number of peripheral blood cells. Until now there is no chemical agent which either singly or in combination which can effectively wipe-out the cancer cells from the bodies of patients suffering from cancer but have no side-effects on normal cells. Therefore, formulation of a new chemical agent that can kill cancer cells and at the same time restore the body cells to normal condition is important. Thus our invention is the process for formulation of such a novel chemical (in combination), which has got an innovative action as mentioned above. Details of our formula The Ruta graveolens 6, homeopathic preparation. Ruta graveolens Linn (family Rutaceae), an extract of which has been used in traditional homeopathy, is a perennial plant The main active compound of this plant is Rutin (C27H30O263H2O), isolated from the leaves of Ruta graveolens. Calcarea Phosphorica (Calcium Phosphate) 3X, Ca3(PO4)2 - is also a homeopathic biochemic preparation available in the market.

Full Text

Field of Invention This invention relates to a combination of Ruta and Calcarea Phos (RUTAPHOS) - A product formulation for regression of intracranial tumors and other tumors occurring in the human body. This product relates broadly to Medicine, specifically Homeopathic Medicine and treatment of Tumors, specifically Tumors of the Brain and has some effect on tumors of other parts. Background of Invention In our clinics, we have the privilege to treat many serious illnesses like brain tumors, cancers and such. By this process, we have acquired tremendous experience and have fixed specific medicines for all diseases. Dr. Prasanta Banerji has presented scientific papers in many international Homeopathic Conferences and in 1995 was invited to present a paper at the 5th International Conference of Anticancer Research, in Corfu, Greece. In this conference he presented a paper on 16 cases of Intracranial Neurocysticercosis completely cured with the homeopathic medicines Ruta graveolens and Calcarea Phosphorica. The paper on the individual action of these drugs was published in "In Vivo": International Journal of In Vivo Research, 15:181-184 (2001). The paper was very well received and research into the svnergistic action of these medicines in combination was started by us at The University of Texas MD Anderson Cancer Center in Houston, Texas, USA. Page 2 of 15 Subsequently, along with the Professor of Cell Biology and Genetics, Dr. Sen Pathak, at the University of Texas MD Anderson Cancer Center, Houston, one paper has been published entitled "Ruta 6 selectively induces cell death in brain cancer cells but proliferation in normal peripheral blood lymphocytes: A novel treatment for human brain cancer" in the International Journal of Oncology, volume 23, number 4, October 2003, 975-982 pages. This paper showed that that the synergistic action of Ruta and Caicarea Phos (Rutavhos) was universally good for all types of tumors of the brain with a marked affinity to cure the glioblastoma. Object of Invention Cancer is a major health problem among men and women worldwide and its incidence is continuously increasing in industrialized nations. During the last two decades, extensive basic and clinical research for diagnosis and treatment of several types of cancer has altered the outcome of the disease. However, it remains one of the leading causes of death in humans. Cancer patients are frequent users of Complementary and Alternative medicine (CAM). Recently use of homeopathy modalities for pain relief, post mastectomy problems, chemotherapy related symptoms, and other consequences of cancer treatment have gained enormous popularity. Homeopathy is an effective and scientific system of healing that assists the natural tendency of the body to heal itself. It is an increasingly popular alternative system of medicine that is based on the principle of similars. Conventional treatments are usually directed towards the symptoms of the diseases, whereas classical homeopathic treatments are mostly targeted towards the individual, but, in our modified treatment methods, specific homeopathic medicines are targeted to specific diseases. The homeopathic practitioner generally believes that use of ultra low doses of chemicals and toxins, if selected properly can be used for cancer prevention and therapeutics. Therefore, further research like conventional medicine may provide scientific basis of effectiveness of homeopathic medicine. The long-term objective of our research has been to understand the effectiveness and underlying synergistic action mechanism of combination of homeopathic drugs such as Ruta graveolens and Calcarea Phosphorica against cancer. These drugs have shown great promise in our clinics for the better management of variety of cancers, especially of the intracranial variety. The main investigation and research being carried out at present by us at various institutions abroad, such as the University of Texas MD Anderson Cancer Center at Houston, USA, and the Huntington Medical Research Institute, Pasadena, California, USA, on the synereistjc action of these medicines is to determine how they modulate the immune system and retard the aggressiveness of tumor growth. In this way, we are far ahead in substantiating, in the laboratory, the clinical findings of above-mentioned homeopathic medicines and have scientific basis for our claim as to their anti-neoplastic properties using conventional scientific methodologies. Summary of the Invention Although conventional chemotherapies have traditionally been used to treat patients with various types of cancer, their side effects and damage to normal cells have been of great concern. Blood forming bone marrow cells are the first to be adversely affected, leading to a decline in the number of peripheral blood cells. Until now there Page 4 of 15 is no chemical agent which other singly or in synergy with anv other similar agent, can effectively wipeout cancer cells from the bodies of patients and vet, not have anv adverse effect on normal cells Therefore, formulation of a new chemical agent, which can kill cancer cells and at the same time restore the body ceils to normal condition, is important Thus our invention, a combination of Ruta and Calcarea Phos (Rutaphos) - A product formulation for regression of intracranial tumors and other tumors occurring in the human body A combination of Ruta and Calcarea Phos (Rutaphos), is the formulation of such a novel chemical (in svnergy) which has an innovative action as mentioned above Details of our formula for a combination of Ruta and Calcarea Phos (Rutaphos) Ruta The Ruta graveolens 6, homeopathic preparation Ruta graveolens Linn (family Rutaceae), an extract of which has been used in traditional homeopathy, is a perennial plant. The main active compound of this plant is a flavone, Rutin (C27H30O16,H2O), isolated from the leaves of Ruta graveolens Known uses of this medicine are as follows ? The fibrous tissue ? The aponeurosis, tendons and the periosteum ? Feeling of intense lassitude, weakness and despair. ? Best action on periosteum, cartilages, eyes and uterus. ? Eye strain followed by headache ? Eyes red, hot and painful from sewing or reading fine prints ? Disturbance of accomodation ? Overstrained ocular muscles ? Pressure over eye brows Asthenopia ? Feeling as if blunt sticks were being poked in ears Page 5 of 15 ? Difficult faces, constipation. ? Carcinoma affecting lower bowel. ? Prolapsus ani every time the bowels move. ? Prolapsus uteri and ani after confinement.. ? Lumbago, stiffback. ? Spine and limbs bruised. ? Deposits in periosteum, tendons and about joints, especially wrist. ? Ganglia. ? Contraction of fingers. ? Sciatica; worse lying down at night. ? Tendons sore. Thigh pains when stretching the limbs. ? Complaints from straining flexor tendons. ? Sprains; injured bruised bones, fractures. ? All parts of body on which he lies, even in bed. are painful as if bruised 2. Calcarea Phosphorica Calcarea Phosphorica (Calcium Phosphate) 3X, Ca3(PO4)2 - is also a homeopathic biochemic preparation available in the market. Known uses of this medicine are as follows: ? It acts upon the vegetative system, exciting moderately the functions of secretion and absorption, resulting in a condition of impaired nutrition of all organs. ? It acts on glands causing induration and swelling. ? It has special affinity for the mucous membranes, the fibrous systems and the nervous and lymphatic systems of the abdomen. ? It acts on deep muscles, producing abscesses. ? Calcarea Phosphorica helps in the formation of bones and ? Its deficiency causes rickets in children; Osteoporosis and osteomalacia in old age, paraesthesia, convulsions, opacity of lens, calcification of basal ganglia, topical ulceration and fungal infection of skin, bleeding disorders, and curdling of milk, positive Chvostek's sign, Trousseau's sign, and tetanic seizures. ? It acts on bones producing swelling, softening and bending of bones. It is a definite stimulant to the periosteum. Hither to unknown before is the fact that in the svnereistic action of the combination, they induce complete regression /prolonged arrest of brain tumors while maintaining normal peripheral blood cell counts. Page 6 of 15 Method of preparation, administration and dosage The product, a combination of Ruta and Calcarea Phos (Rutaphos) is to be prepared in the following way: 10 millilitres of Ruta Graveolens 6 is added to 1 litre of distilled water (The Pharmacopoeia of India). In this solution are suspended 65 grams of Calcarea Phosphorica 3X. This combination is to be shaken well before being taken, 2 millilitres a dose orally four times a day. The dosage is the same for adults as well as for children. Brief descriptions of the accompanying drawings Figure 1. Bar diagram study of the chief complaints of neoplastic cases of intracranial tumors used to substantiate evidence. Figure 2. Possible mechanism of the synergistic effect of the Ruta graveolens (flavone) and Calcium Phosphate on neoplastic brain tumors. Detailed description of the invention with reference to the accompanying drawings Intracranial tumors are not only important for their significant incidence throughout the globe; which range from 11 to 19 per 100,000 population (1,2), but these lesions are mainly notable for the difficulty of their treatments, poor prognosis and the intractable condition of those suffering from them. However, in about fifty percent cases the intracranial lesions are metastatic where the primary sites are present elsewhere in the body. In the remaining cases, the tumors are mainly derived from neurons, glia or their supporting meningo-vascular structures. A particularly embarrassing situation is Page 7 of 15 that of histologically proved benign tumors that act as malignant ones due to their location of being in the intracranial cavity and thereby pressing on vital structures. If we look into the methods of treatment these tumors, though the scenario appears not much encouraging, there are various modalities of treatment, namely medical therapy, surgery, radiation therapy, chemotherapy and immunotherapy. In a large number of such tumors even these modalities are difficult to administer. Thus in many cases total surgical removal of the tumor is not possible and sometimes partial removal is effected. Similarly response to radiotherapy and chemotherapy is poor in many cases and in a considerable percentage of cases their administration is contraindicated. In some cases i.e., in patients with supratentorial tumors, anticonvulsants are needed mostly as a palliative measure. In our clinics however, we have successfully treated patients of intracranial tumors for a long time with alternative medicinal preparations of Ruta Graveolens and Calcium Phosphate. Here we give as examples sixteen such cases that initially presented with various clinical signs and symptoms of intracranial tumors, which were also confirmed radiologically and / or histologically. Most of the cases were almost at their terminal stage of the disease when our treatment was started. The patients gradually improved as indicated by serial C.T scan studies and clinical examinations. Most of the tumors have regressed, a few are in a stage of prolonged arrest and the patients have resumed their normal lives. Page 8 of 15 In the long clinical experience of the inventors during the three decades, 1955-85, it became evident that the combination of a Ruta graveolens (Ruta g.; it contains rutin which is a flavone) and Calcium Phosphate was effective in regressing or arresting intracrania! tumors. Hence, from 1985 a detailed study was undertaken of fresh cases of such tumors. In all cases the combination therapy was administered, to study the synergjstic effect of the combination. The findings are given below. Chief Complaints: List of Exemplary Cases: Page9of 15 Patients with gliomas, meningiomas, retinoblastotna, neuroblastomas and cramopharyngiomas. Results of Treatment Analysis of the responses of these patients to our treatment indicates complete regression in 80% cases and prolonged arrest in 20% cases. The average duration of treatment was 34.7 months with a range of 8 to 89 months. Almost all patients were incapacitated during initiation of treatment and all of them are now normal and performing their usual regular activities. The details of the outcome of our treatment are given in the tables below. Page 10 of 15 Table of Results Discussion Here sixteen cases of neoplastic intracranial tumors are presented, as examples, where all medical records were properly maintained. The age of the patients varied between 3 ½ to 65 years. The age specific incidence of brain tumors has two peaks one just after birth i.e. 0 to 3 years of age, and one after middle age. Brain tumors are surpassed only by leukaemia as a cancer-related cause of death in children(3). These are statistical observations, and brain tumors can occur at any age. Intracranial tumors may lead to a generalized disturbance of cerebral function, and to signs and symptoms of increased intracranial pressure. In consequence, there may be personality changes, intellectual decline, emotional instability, seizures, headaches, nausea, vomiting, paralysis, loss of vision and malaise. If the pressure is increased in a particular cranial compartment, brain tissues may herniate into a compartment with Page 11 of 15 lower pressure. Signs and symptoms differ as per the position of the growth inside the brain. In this study we found that headache is the commonest symptoms in all cases. Headache in neoplastic tumors is mainly due to traction on the dura, blood vessels or cranial nerves, which results from local compression, elevation of intracranial pressure, oedema or hydrocephalus. Paralysis and problems of vision are also more commonly found in all neoplastic tumors (please see Figare 1}. This is mainly due to intra-axial location of all neoplastic tumors. With conventional treatment including multi-modality therapy, there are recurrences in many cases and most of the cases show poor prognosis. After treatment with Alternative medicines - a synergistic combination of Ruta Graveolens and Calcium Phosphate, there was definite improvement either as total regression or prolonged arrest. In most of the cases of intracranial tumors the patients are symptom free and enjoying their normal lives. At present it is very difficult to explain properly how these Alternative medicines act on brain tumors. The Ruta Graveolens may act through CD4 + T cell or through direct action on purines and pyrimidines. The active ingredient of the Ruta Graveolens which is a flavone and it's glycone are well known for their anti-inflammatory activities, gene regulations, chemoprevention of 20-methyl cholanthrene induced tumorigenesis in male Swiss albino mice, protection from UV-B induced DNA damage, prevention of gastric lesions induced by ethanol in rats and growth inhibitory effect on primary human transitional cell carcinoma mediated through type II estrogen binding sites (Type II EBS), The Flavone is also known to Page 12 of 15 protect against nuclear hazards and capillary bleedings. The Flavone can combine with all types of amines including purines and pyrimidines. In recent years many studies have been done with Rutin which is an active ingredient of Ruta Graveolens. It decreases urinary excretion of thymine glycol and thymidine glycol which are indices of DNA base damage in the whole body (4), can act as free radical scavenger and inhibitors of inflammatory and fibrotic process (5), protect DNA strand breaks (6) and prevents mutagenesis (7). The idea of addition of phosphate is that it activates phospholipase which cleaves a compound in the cell membrane called phosphatidylinositol biphosphate (PIB) which in turn activates protein kinase C which eventually lead to the synthesis of protein complex AP-1. The cleavage product by phospholipase also triggers an influx of already administered Calcium ions into the cell which will transfer cycloplasmic nuclear factor of activated T cell to the nucleus via Calmodulin and Calcineurin associated with activation of all Calcium depending enzymes. Calcineurin mediates induction of human tumor necrosis factor (TNF) alfa gene in stimulated T and B cells (8). All these changes ultimately lead to apoptosis (9) or spontaneous regression/prolonged arrest (10) of different neoplastic tumorstplease see Figure 2). Thus this study clearly shows that a synergistic effect of the combination of Ruta Graveolens and Calcium Phosphate can be considered one conjointly (synergistic) important nucleating factor for initiating Spontaneous Regression or Prolonged Arrest of intracranial tumors. Although the present invention has been described in terms of specific embodiments, changes and modifications can be carried out without departing from the scope of the invention, which is intended to be, limited only by the scope of the appended claims. Page 13 of 15 References 1. Russell D.S. & Rubenstein L.J.; Pathology of Tumors of the Nervous System, 5th Edition; Baltimore, Williams & Wilkins; 1989. 2. Black P.M.; Brain Tumors, Parts 1 &2; N. Engl. J. Med.; 324: 1471 - 1476, 1555 - 1564; 1989. 3. Harsh G.R. IV & Gutin PH.; Brain Tumors; In Con's Current Therapy; Edited by Rakel RE.; W.B. Saunders Co.; 884 - 7; 1989. 4. Funabiki R, Takeshita K, Miura Y, Shibasato M, Nagasawa T, Dietary supplement of G ~ Rutin reduces oxidative damage in the rodent model, J Agric Food Chem, 47; 1078 - 82: 1999. 5. Afanas'eva IB, Ostrakhovitch E A, Mikhal'chik E V, Ibragimova G A, Korkiha L G, Enhancement of antioxidant and anti - inflammatory activities of bioflavonoid rutin complexation with transition metals. Biochem Pharmacol, 61: 677 - 84, 2001. 6. Aherne S A, O'Brien N M, Mechanism of protection by the flavonoids, quercetin and rutin, against tert-butylhydroperoxide - and menadione - induced DNA single strand breaks in Caco -2 cells, Free Radic Biol Med, 29: 507 - 14, 2000. 7. Bear WL, Teel RW, Effects of citrus flavonoids on the mutagenicity of heterocyclic amines and on cytochrome P 450 1A2 activity, Anti Cancer Res, 20: 3609 - 14, 2000. 8. Goldfeld A.E., Tsai E, Kincaid R, et al.; Calcineurin mediates human tumor necrosis factor alpha gene induction in stimulated T and B cells; Journal of Experimental Medicine; 180(2), 763 - 8; 1994. 9. Tomei L.D. & Cope F.O. (eds); Apoptosis, The Molecular Basis of Cell Death. Cold Spring Harbor, New York; Cold Spring Harbor Laboratory Press; 5 - 29; 1991. 10. Everson T. & ColeW; Spontaneous Regression of Cancer; Saunders; Philadelphia; 1996. Page 14 of 15 We claim: ] A combination of Ruta and Calcarea Phos (Rutaphos) - A new product formulation for regression of tumors of the brain, which is also effective in other tumors occurring in man to some extent, which comprises Ruta Graveolens 6 and Calcarea Phosphorica 3X and distilled water (The Pharmacopoeia of India) in the proportion of 1 ml - 10 ml : 1 gm - 10 gm : 1 ml - 200 ml. To The Controller of Patents The Patent Office, Kolkata 2. A product as claimed in Claim 1., wherein any other ratio of Ruta Graveolens 6, any other ratio of Calcarea Phosphorica 3X and any other ratio of distilled water (The Pharmacopoeia of India), will also have a definite beneficial effect on brain tumors and other malignant tumors of the body. Cancer is a major health problem among men and women worldwide and the incidence is continuously increasing in industrialized nations. During the last two decades extensive basic and clinical research for diagnosis and treatment of several type of cancers have altered the outcome of the disease. However, it remains one of the leading causes of death in humans. Although conventional chemotherapies have traditionally been used to treat patients with various types of cancer, their side-effects and damage to normal cells have been of great concern. Blood forming bone marrow cells are the first to be adversely affected, leading to a decline in the number of peripheral blood cells. Until now there is no chemical agent which either singly or in combination which can effectively wipe-out the cancer cells from the bodies of patients suffering from cancer but have no side-effects on normal cells. Therefore, formulation of a new chemical agent that can kill cancer cells and at the same time restore the body cells to normal condition is important. Thus our invention is the process for formulation of such a novel chemical (in combination), which has got an innovative action as mentioned above. Details of our formula The Ruta graveolens 6, homeopathic preparation. Ruta graveolens Linn (family Rutaceae), an extract of which has been used in traditional homeopathy, is a perennial plant The main active compound of this plant is Rutin (C27H30O263H2O), isolated from the leaves of Ruta graveolens. Calcarea Phosphorica (Calcium Phosphate) 3X, Ca3(PO4)2 - is also a homeopathic biochemic preparation available in the market.

Documents:

00180-cal-2002-abstract.pdf

00180-cal-2002-claims.pdf

00180-cal-2002-description(complete).pdf

00180-cal-2002-drawings.pdf

00180-cal-2002-form-1.pdf

00180-cal-2002-form-13.pdf

00180-cal-2002-form-18.pdf

00180-cal-2002-form-2.pdf

00180-cal-2002-letters patent.pdf

180-cal-2002-granted-abstract.pdf

180-cal-2002-granted-claims.pdf

180-cal-2002-granted-description (complete).pdf

180-cal-2002-granted-drawings.pdf

180-cal-2002-granted-form 2.pdf

180-cal-2002-granted-specification.pdf