Background Art [00021 Cancer cells are different from normal healthy cells in several respects. One way in which virtually all cancer cells differ from normal healthy cells is that cancer cells derive a major proportion of their energy from glycolysis. Normal healthy cells utilize an oxidative metabolism in which only a small proportion of energy is derived from glycolysis. Cancerous neoplasms require an alteration of energy production with transition from non-invasive premalignant to invasive malignant morphology, ranging from large beginning tumors to necrotic cancers, including the acquisition of angiogenesis, increased glucose utilization (with increased lactic acid production) and typical tumor morphologies.

[0003] The increased lactic acid production of multi-cell tumors causes the micro environment outside the tumor to become more acidic, leading to a reduced pH. This decreased pH kills the normal tissue cells, which surround the tumor and which require a pH of 7.31 or higher to maintain health and viability. As a consequence, the tumor is surrounded by necroticised normal cells. When sufficient alkalinizing agents are not available to the normal, healthy cells and tissues surrounding the tumor, this promotes the extension ("invasion") of the tumor into normal tissues, increasing tissue permeability and the

formation of new blood vessels (angiogenesis).

(0004] The values of pHe measured (the pH of the immediate environment of the tumor), vascularization, angiogenesis and surrounding tissue permeability correlate with invasiveness and metastasis. Low pHe makes cultured tumor cell lines more metastatic. Metastasis is responsible for 90% of cancer deaths, according to the American Cancer Society.

[0005] Cancerous viability zone is dependent on an acidic micro-environment. This is due in part to their aberrant energy metabolism, which produces lactic acid and carbonic acid and in part to incomplete vascularization, which causes insufficient oxygen supply (hypoxia).

The common denominator for virtually all cancerous tumors is a reduced pH at the tumor's edge. This pHe (micro-environment) generally ranges between 5.50 and 7.20 with an optimum growth rate occurring at a pH between 6.60 and 6.80.

[0006] The energy metabolism of tumor cells being acidic is uniquely different from viable healthy cells and provides a basis for the selective destruction of all stages of advancement that may lead to cancers and all varieties of cancerous neoplasms.

[0007] DEFINITIONS : pH, where the p stands for the word"power"while the H stands for the element Hydrogen. The actual definition of pH is the negative logarithm of the hydrogen ion activity. pH=log (H+). The parameter pHe is the pH on the exterior, and pHi is the pH on the interior of the cell.

[0008] The pH within tumor cells (pHi) is similar to (or even more alkaline than) the pH of normal tissue cells. The pH of the micro-environment of the tumor (pHe), however, is more acidic than that of normal tissues. It should be noted that the term"tumor micro- environment"refers to both the non-cellular area within the tumor and the area directly outside the tumorous tissue and does not pertain to the intracellular compartment of the cancer cell itself.

[0009] Tumors tend to be both hypoxic and acidic. Due to microcirculatory characteristics, chronically hypoxic tissues are going to be (i. e. are always) acidic, whereas transiently hypoxic tissues may be acidic. The more central portion of the tumor is hypoxic, the exterior is transiently hypoxic.

[0010] Cancers exhibiting the lowest pHe values are more acidic and more aggressive and hostile to the surrounding normal healthy viable cells and more likely to be fatal to the patient. Low pHe promotes persistent antigenic and metastic signaling, metastatic spread of cancer and neovascularization (including angiogenesis, enhancing blood flow to the tumor mass). Low pHe decreases the efficacy of the immune response to cancer cells. An acidic hypoxic environment causes genomic instability, and increased resistance to conventional cancer treatment procedures (e. g. , drugs, radiation).

[0011] There are other important consequences of aberrant energy metabolism. As compared to normal cells, cancer cells have a lower energy charge (ATP/ (ADP + Pi)).

Additionally, cancer cells typically have cellular distributions of ions that are different from normal healthy cells. Neoplastic and cancer cells usually contain excess internal sodium and grossly excess internal calcium, often with a deficiency in internal potassium. Cancer cells have ion fluxes across their membranes that are different from normal cells (e. g. increased H+ efflux). Cancer cells invariably have membrane electrical potentials (inside relative to outside) that are less electro-negative than normal cells. Aberrant ion concentrations such as high internal sodium or high internal calcium can induce apoptosis and or can modify the recognition of the cancer cell by the immune system.

[0012] Development of cancer involves a competition between the growth of neoplastic cells and their destruction by immunological processes. The genetic changes accompanying carcinogenesis have attracted great interest and much is known about the molecular mechanisms involved. Such changes are a prerequisite to the development of the malignant disease, but are not sufficient by themselves to overcome the immune defenses. Thus, cancer can be prevented by therapies that potentiate the proper functioning of defenses such as immune response and apoptosis, so the balance between cancer propagation and cancer elimination is shifted to promote cancer elimination.

[00131 PRIOR ART TREATMENT MODALITIES [0014] 1. Surgery: cancer therapies rely heavily on surgical intervention for the removal of the tumor load. There are high risks and stress associated with the surgery and post operative

complications, high costs and high risks of life threatening metastases. It is extremely difficult to be certain that the entire cancer is completely removed as residual cancer cells frequently survive and metastasize. Surgery produces pain (acidosis), reduction of which requires a separate drug that potentially contributes to chemical and psychological addiction.

[0015] 2. Chemotherapy relies primarily on differential toxicity. Treatment in general is toxic to normal viable cells and often does not reach the targeted tumor or tumors.

[0016] 3. Radiation therapy's mode of action is by the causation of damage to rapidly growing cells. Radiation also causes permanent genetic damage to non-cancerous normal healthy viable cells and further contributes to the reduction of pH.

[0017] 4. Immunotherapy employs several forms of immune cells isolated from patient's blood (e. g. dendritic cells, lymphokine activated killer cells). A limitation of the immunotherapeutic approach is the limited number of tumor types that have successfully been treated (e. g. melanoma, kidney tumors), the complex and expensive procedure and the limited success rates.

[0018] These prior art therapies often adversely affect ionic function and further reduce the systemic pH, pHe and pHi and contribute to a reduction of the acidic tumor micro- environment and further compromise the patients survival and recovery rates and compromise nutrient assimilation. Note, approximately thirty percent of cancer patients die from malnutrition. A far better strategy is to provide therapies that alter the tumor cells ability to transport H+ and other ionic species across its membrane, by obtaining a targeted shifting (increase) to a physiologically optimum, functioning range to a cellular pHe and cellular pHi range that is outside the cancer cell's viability zone and simultaneously provides an electro-physical barrier to pH reduction and improves resistance to tumor formation and invasion, and simultaneously switches off the angiogenesis and metastasis signals that occur in a reduced pH eliminating metastasis seeding and neovascularization.

[0019] The foregoing discussion reflects the current state of the art of which the present inventor is aware. Reference to, and discussion of, this material is intended to aid in discharging Applicant's acknowledged duty of candor in disclosing information that may be

relevant to the examination of claims to the present invention. However, it is respectfully submitted that none of the above information discloses, teaches, suggests, shows, or otherwise renders obvious, either singly or when considered in combination, the invention described and claimed herein.

Disclosure of Invention (0020] The invention provides a new method and formula for administering a non-toxic pharmaceutical composition (drug) to mammalian patients and more specifically humans suffering from cancerous neoplasms for eliminating and preventing the formation of a hostile cancer viability zone and tumor growing micro-environment. The nontoxic invention is effective in treating a wide variety of cancers and for anti-metastasis and remission from cancerous tumors and will work on cancers with larger patient populations. The formula has a high efficacy vs. toxicity ratio, enabling a large portion of the cancer treatment to be on an outpatient basis, resulting in substantial cost savings and reserving costly in-patient testing for patients with advanced or recalcitrant cancers.

[0021] The inventive formula contains cesium and rubidium, which are alkali metals with chemical and physical characteristics similar to potassium, the main internal cation of normal healthy viable cells. Potassium ion currents are central to the ionic physiology of normal viable healthy cells. Mammalian cells generally respond to hypoxic conditions that induce glycolytic energy metabolism with large potassium fluxes. Trans-membrane fluxes and cellular accumulation of cesium and rubidium ions are governed by similar cellular mechanisms as those which govern potassium movements; however, cesium and rubidium ions move at slower rates and accumulate to different degrees.

[0022] These ions alter the ionic physiology of the cell, including inhibition of trans- membrane movement of potassium. Cesium and rubidium are effective for the control of potassium fluxes and linked hydrogen ion (H+) and other fluxes making them essential elements for anti-cancer activities that target the metabolic differences on all varieties of cancers'neoplasms by manipulating the systemic pH and the pHe of the localized tumor

micro-environment and provides a targeted shifting (increase) of the pHe and pHi of normal healthy viable cells to their optimum or near optimum range (outside cancers viability zone), providing an electrophysical barrier resisting tumor growth, tumor invasion, metastasis proliferation seeding and adhesion and neovascularization for all stages of malignancies including cancers highly resistant to conventional therapies, bypassing cancer cell's mechanisms of resistance against conventional anti-cancer procedures and drugs.

[0023] A therapy that takes into account the consequences of low pHe and low systemic pH, and that increases tumor pHe, without causing serious side effects, is a significant improvement over the prior art.

[0024] An advantage of the invention is that by administering water soluble salts that provide circulating ions of cesium and or rubidium, shifting the systemic and localized pH to the physiologically optimum range, eliminates acidosis locally in the tumor microenvironment and systemically renders cancer cells non-viable by optimizing anti- cancer immune surveillance and function, reducing the lifelong health costs by optimizing the electrophysical capacity of healthy viable cells for cancerous disease resistance.

[0025] A further advantage of the invention is that it can be cost effectively administered as a stand alone therapy or to co-administer with anti-metastatic treatment therapies useful in the (immuno) therapy of cancers, thus enhancing the ability of normal healthy viable cells and tissues to tolerate and resist acidic invasions and decreased pHe and pHi and eliminating the tumors ability to transport essential ionic species (e. g. H+) across its membranes, especially when used in combination with conventional cancer therapies such as chemotherapy, radiotherapy and surgery and prevents the recurrence of cancer and increases the life expectancy of patients with advanced cancers.

[0026] The formula described in the invention has several related effects on development of the cancer micro-environment resulting from the same internal dynamics. First, the formula interferes with the hypoxic acidic energy metabolism of the cancer cells. This effect renders the cells less able to supply the energy required for the rapid proliferation typical of cancer cells resulting in elimination of the viability zone of the cancer cells. Secondarily, the

formula reduces acidification (both systemically and locally in the tumor micro-environment) and increases oxygenation, eliminating the adverse effects caused by acidic hypoxia.

[0027] The key to using aberrant energy metabolism as a way to specifically target the cancer cell's micro-environment is to administer an ionic formula comprising an alkaline salt or salts that can reduce localized acidity levels in cancerous tumors that has little or no toxicity to normal healthy viable cells and increases the pH of the tumor micro-environment, thus causing the non-viability and apoptosis of tumor cells, leading to the elimination of tumors and metastases forcing the cancer cells to die or normalize. Administering sufficient quantities of the formula reduces pain and eliminates the hypoxic acidification produced by the cancer cells so that the systemic physiologic pHe ranges between 7. 31 to 7.44, and more preferably 7.40. When the pHe is close to this physiological optimum range, anti-cancer activities of the immune system function in an optimal biochemical, ionic and electro- physiological environment.

[0028] Malignant tumor survival requires neovascularization which preferentially occurs at reduced systemic pH and pHe. The induction of new blood vessels (neovascularization /angiogenesis) will be suppressed or eliminated at more alkaline pHe values. An acidic/hypoxic micro-environment is a major factor in the induction of metastasis, propagation, and seeding. Therefore, administration of sufficient quantities of the formula will eliminate the risk of metastatic proliferation will also mitigate the acidotic effects of tumor necrosis, thus reducing the need to surgically remove dead tumor tissue in some patients and eliminates tumor-generated pain.

[0029] The formula may be administered as a short-term therapy, or long term prophylactic cancer therapy to electrophysically suppress the formation of the electrophysical source of cancer. The formulas contain the ions of cesium and or rubidium and alkalinize (donate alkaline electrons) the acidic hypoxic dependent cancerous neoplasms. The low pHe is a consequence of tumor growth and aggressively hostile to the growth and survival of normal viable cells and promotes tumor invasion and perfusion and further contributes tumorigenic transformation. The common denominator for all cancerous neoplasms is that they require a

reduced extracellular pHe (microenvironment) which is more acidic than the intracellular pHi. The cancerous tumors pHe (tumor microenvironment) and viability zone ranges from 5.50 to 7.25, having an optimum growth rate ranging from 6.7 to 6.8. Cesium and or rubidium ions have beneficial ionic characteristics for normal viable healthy cells that require a pHe ranging from 7. 31 to 7.45, optimally 7.37 to 7.40, with an optimum pHi ranging from 6.60 to 6.80. The formulas cesium and rubidium ions raise the systemic pH of the patient and provide sufficient circulating concentration of cesium and or rubidium ions to the tumor microenvironments, thus increasing tumor pHe to a physiologically optimum range for controlling the rate of cancer apoptosis and or necrosis. The invention neutralizes the acidic substances excreted by the cancer cells. Such a response is instrumental in reduction and elimination of tumor acidotic generated pain and systemic prevention of metastasis and tumor invasion.

[0030] The alkaline salt solution (drug) can be administered for injection directly into the blood circulation in sufficient quantities providing sufficient circulating concentrations to a cancer patient to obtain sufficient ionic saturation for reducing the localized acidity levels in the tumor micro-environment and systemically eliminating metastasis mobilization, seeding and adhesion. The cesium and rubidium ions encapsulate the primary tumor and sites other than the site of the primary tumor and promote systemic pH resistance to cancer formation propagation and neovascularization. The alkaline ions produce ionic changes in the pHe and systemic pH manipulating ionic chemistry which enhances the ability of healthy viable cells and normal tissues surrounding the tumor to tolerate and resist decreased pHe and decreased pHi and resist transport of H+ across its membranes, providing an electrophysical barrier to tumor invasion, eliminating the cancer viability zone (formation and propagation environment) and preventing the formation of the cancer-causing microenvironmental conditions, which are a prerequisite for tissue invasion and metastatic seeding and adhesion and the aberrant energy metabolism necessary for the viability of cancer formation and growth.

[0031] Administering sufficient quantities of the formula reduces the acidity levels and

eliminates the tumor cell's ability to transport H+ across its membrane, and prevents the development from non-invasive premalignant to invasive malignant morphology including the acquisition of angiogenesis, and increases glucose utilization and acid production to effectively obtain cancer prophylaxis.

[0032] The efficacy in a particular patient can be assessed through observations relating to cancer ionic physiology. Clinical observation and diagnostic testing is used for adjustment of the dosages, for controlling the degree, or rate, of efficacy, in order to fall within the targeted pHi and pHe and systemic pH ranges; as an example the targeted saliva pH should range between 7.35 to 7.50, and only briefly rise above 7.70.

[0033] The invention provides a method and formula for administration of salts containing cesium and rubidium for surgical intervention, to simplify the procedure, by administering the formula one to two weeks prior to surgery to encapsulate cancerous tumors to define the border between the cancerous tumor and non cancerous healthy tissues, minimizing surgical trauma.

[0034] The invention provides a non-addictive anti-cancer formula for readjusting ionic function to specific pH targets suitable for all stages of cancer including advanced staged cancers, lactic acidosis, which substantially reduces the pH of the entire blood circulation common in the end stages of terminal cancer. By administering sufficient circulating concentrations of ions of cesium and or rubidium the pHe, pHi and systemic pH are optimized and stabilized. Effects include those secondary to the inhibition of the large trans- membrane potassium movements resulting from hypoxic energy metabolism. The formula is administered to patients suffering from cancer to obtain shifts in pH, correction of excessive sodium accumulation, increase of membrane electrical potential and improvement of capacity of the sodium/calcium exchange mechanisms and promotes systemic hydration.

[0035] Administration of the formula suppresses a wide variety of infectious microorganisms which often have acidotic energy metabolisms as a large number of cancer deaths are due to secondary infections, primarily from bacteria. If a patient's immune system is suppressed by acidosis, either bacterial-included or tumor generated by raising the pH to

the targeted physiologically optimum ranges, and thus are eradicated. The treatment described herein will improve the systemic functioning of the immune system, helping the patient fight off secondary infections and simultaneously reduces or eliminates cancer- induced acidotic pain and inflammation.

[0036] The invention further provides a method for monitoring a cancer patient's saliva pH for indicating the predisposition for the development of cancer, and provides a means for detecting a wide variety of cancers prior to the appearance of clinical symptoms and simultaneously indicates the stage or progression of the cancer and determines the dosages to be administered for therapeutic gain in cancer prophylaxis and therapy.

[0037] The inventive formula prevents recurrences of malignant tumors after the surgical treatment and increases the average life expectancy of patients with late stage cancers and avoids surgical treatment in a number of benign, premalignant and malignant tumors.

[0038] The invention further provides a method and formula for gene repair and therapy by inhibiting the transition from premalignant (non-invasive) to malignant (invasive) morpholog including the acquisition of angiogenesis and increased glucose utilization (with increased lactic and carbonic acid production). This low pH, hypoxia and nutrient deprivation can lead to mutations and result in genetic heterogeneity in tumors, thus cell lineages are selected with tolerance to tumor microenvironment and increased proliferation.

[00391 Administration of the formula can be used as an immuno modulatory therapy for a wide variety of cancers. The targeted goal is to manipulate pHi of healthy viable cells above the chronic mutation pH of 6.40 obtaining a pHi in a physiological optimum range between 6.60 to 6.80 for gene stabilization and genetic systemic repair and cancer prophylactic effects and optimizing the immune system to fight cancer cells to obtain prophylaxis of a wide variety of cancerous neoplasms.

[0040] The invention further provides a method and formula for improved chemotherapy and radio-therapy that are negatively affected by a low pH. Administration of the formula enables normal healthy tissues to tolerate and resist decreased pHe and decreased pHi, which controls the transport of H+ across its membranes and provides an electrophysical barrier to

resist tumor invasion and reduces therapeutic chemotherapy dosages, enhancing cytostatic efficiency and enabling healthy viable cells to reach a physiologically optimum pHe range between 7.31 and 7.45, preferably 7.40 ; thus inhibiting the tumor cell's ability to repair themselves after damage by radiation or chemotherapy, promoting the enhancement of tumor necrosis after X-ray radiation or chemotherapy and simultaneously reducing adverse symptoms, such as nausea, physiological depression, energy loss, and chronic fatigue, which are common in chemotherapy and radiotherapy by reducing the damaging acidotic effects of these procedures and the risk of DNA mutations caused by radiation and chemotherapeutic drugs, thus reducing the risk of causing further cancer in healthy cells.

[0041] The invention further provides a method and formula for immunotherapy and prophylaxis of a wide variety of cancers neoplasms. The administration of the formula with potassium and other electrolytes enhances the ability of immune cells including macrophages, natural killer cells and T-cells to obtain an optimal functional equilibrium, obtaining an improved immune surveillance for tumor cells.

[0042] It is known in the art that more acidic conditions (reduced pH) create a status of chronic immune stimulation and inflammation, which is evidenced by impaired functional immune balances. Restoration of the optimum (slightly alkaline) pH not only strongly improves immune function, but also the interaction between the immune system and the psychoneuroendocrine system (e. g. hypothalamus-pituitary-adrenal axis) is positively influenced. Thus, this immunomodulatory treatment not only stimulates the immune reactivity towards cancer cells, but also can improve the mental health situation of cancer patients.

[0043] The invention further provides a method and formula for suppression of acidophilic pathogens and disease resistance. The compromised immune system of cancer patients (as a consequence of inflammation, chemotherapy, or radiotherapy) is often not capable of resisting microbial invasion combined with the impaired immune-surveillance regarding tumor cells combined with the expression of viral genetic material that may lead to cancer, and is suppressed by eliminating the pH dependent acidophilic pathogen's viability zone.

[0044] Administration of the formula enables normal healthy viable cells and tissues to act as a barrier to pathogen invasion which enhances the ability of normal healthy viable cells to electrophysically resist decreased pHe and pHi by sufficient administration of the formula increases the pH, stimulating immune response and obtains pathogen suppression, the targeted shifting (raising) increasing the ionic concentration of the normal healthy viable cells pHe and pHi to physiological optimum range and thus eliminates the reduction of systemic pH, cellular pHi, and cellular pHe and mitochondria pH. Simultaneously, extending the normal healthy viable cell's life span and enhances resistance against acid-mediated invasion of a wide variety of viruses and other opportunistic pathogens, such as bacteria, yeasts and fungi.

[0045] The invention further provides a method and formula for suppression of tumor generated pain. Cancerous tumors generate lactic and carbonic acid and (H+) secretion lowering of the pH of the tumor microenvironment. This acid secretion is the cause of tumor- generated pain. The current invention's alkaline ions preferably raise the pHe above 7.21, a pH level that the lactic and carbonic acids disassociate, thus reducing or eliminating tumor generated pain in cancer patients. Thus, the normal cells surrounding the tumor cells, including nerve and immune cells are restored including physiological improvement to intracellular energy production and metabolism.

[0046] The invention further provides a method and formula for suppression and elimination of neovascularization and angiogenesis. The formula is therapeutically effective for repairing and normalizing neovascularization and preventing neovascularization. The administration of the formula increases (raising) the normal viable cell's pHe and pHi to more physiological optimum values outside cancer's viability zone and manipulates the neovascularization pH. Cesium and rubidium ions reduce or eliminate the lowering of the systemic pH, cellular pHi and cellular pHe and have angiogenesis inhibiting activity i. e. the formula inhibits the formation of blood vessels. As an antiangiogenic agent, the ions will be effective in treating degenerative diseases which require a separate and new blood flow.

[0047] The invention further provides a method and formula for supporting surgical

therapy for cancer and suppresses infections during surgery and recovery and by promoting the healing cycle of the normal viable cells, and enables a previously unavailable method and formula of surgical wound care. Additionally, residual tumor cells will encounter a more hostile environmental (more alkaline) pHe and, as a consequence, they are suppressed and eliminate the recurrence of malignant tumors after the surgical treatment and increase the average life expectancy of patients with late stage cancers. The anticancer therapy avoids surgical treatment in a number of cases. It is therefore an object of the present invention to provide a new and improved [0048] Other novel features which are characteristic of the invention, as to organization and method of operation, together with further objects and advantages thereof will be better understood from the following description, in which preferred embodiments of the invention are illustrated by way of example. The various features of novelty which characterize the invention are pointed out with particularity in the claims annexed to and forming part of this disclosure. The invention resides not in any one of these features taken alone, but rather in the particular combination of all of its structures for the functions specified.

[0049] There has thus been broadly outlined the more important features of the invention in order that the detailed description thereof that follows may be better understood, and in order that the present contribution to the art may be better appreciated. There are, of course, additional features of the invention that will be described hereinafter and which will form additional subject matter of the claims appended hereto. Those skilled in the art will appreciate that the conception upon which this disclosure is based readily may be utilized as a basis for the designing of other structures, methods and systems for carrying out the several purposes of the present invention. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention.

[0050] Further, the purpose of the Abstract is to enable the national patent office (s) and the public generally, and especially the scientists, engineers and practitioners in the art who are not familiar with patent or legal terms or phraseology, to determine quickly from a cursory

inspection the nature and essence of the technical disclosure of the application. The Abstract is neither intended to define the invention of this application, which is measured by the claims, nor is it intended to be limiting as to the scope of the invention in any way.

[0051] Certain terminology and derivations thereof may be used in the following description for convenience in reference only, and will not be limiting. For example, words such as"inward"and"outward"would refer to directions toward and away from, respectively, the geometric center of an area and designated parts thereof. References in the singular tense include the plural, and vice versa, unless otherwise noted.

Best Mode for Carrying Out the Invention [0052] The preferred embodiment provides an ionic pH cancer therapy for inhibiting tumor metastatic activity for effective anti-vascularization and tumor suppression and remission for a wide variety of cancers including, but not limited to adenocarcinoma, adenocystoma, undifferentiated cancer, sarcoma, neurofibroxanthoma, fibroxanthoma, chondrosarcoma, osteosarcoma, lymphosarcoma, reticulosarcoma, carcinoma, carcinosacroma, adenoma prostate and mastopathy ; and a wide variety of cancerous neoplasms such as but not limited to throat, lungs, stomach, small intestine, colon, rectum, nasal cavity/sinuses, nasopharynx, gall bladder, kidneys, bladder, breast, heart, cervix, uterus, vagina, ovaries, testes, thymus, prostate, bones, skin, brain, liver, including undifferentiated cancer.

[0053] The invention provides a method and formula by administering therapeutically effective dosages of salts containing cesium and or rubidium ions and balanced electrolytes, in a pharmaceutical delivery form which meets certain ionic, electrochemical and electro- physiological cellular requirements, and supportive nutrients to raise the systemic pH in cancer patients to eliminate acidic hypoxia, the alkaline ions differentially raise the pHe of the tumor microenvironment due to the low buffering capacity of the cancerous tumors' interstitial fluid in the tumor microenvironment. When the acidity of a cancerous tumor's micro environment is shifted to a more electro-physiologically optimum pHe range above 7. 31, preferably 7.37 to 7.42, the patient's metabolic and immune systems (including

antibodies, macrophage cells, etc. ) function more effectively and reduce and inhibit cancer cell replication. If a patient's immune system is suppressed by a systemic or localized acidic hypoxic biological environment, either viral or bacterial-induced or tumor-generated, the therapy described herein will improve the immune response and function by obtaining a targeted increase of the systemic pH and pHe to physiologically optimum ranges to resist a wide variety of secondary infections. Such a response is instrumental in the prevention of cancer growth, invasiveness and anti metastasis and promotes tumor immunology response by the immune system.

[0054] METHOD OF MANUFACTURE [0055] The invention utilizes pharmaceutically acceptable salts containing cesium and/or rubidium ions, as a stand alone therapy, or as an effective adjunct in conjunction with a wide variety of conventional cancer therapies as an example, but not limited to: any combination of pharmaceutically acceptable salts or compounds containing ions of cesium and rubidium which disassociate and ionize may be employed in the formula as an example but not limited to the term"pharmaceutically acceptable salt"is intended to include all acceptable salts such as, but not limited to, citrate, malate, carbonate, chloride, fumarate, phosphate, Arginate, Ascorbate, Caprylate, Cysteinate, Methionine, Glutamate, Gluconate, Glycinate, Aspartate, Asporotate, Bisulfonate Lysinate, humic Fulvic, Succate, Carnate, Lactate, Trisulfate, Tartrate, acetate, lactobionate, benzenesulfonate, laurate, benzoate, bicarbonate, benzoic, caseinate, bisulfate, mandelate, bitartrate, mesylate, borate, methylbromide, bromide, methylnitrate, calcium edetate, methylsulfate, camsylate, mucate, napsylate, nitrate, clavulanate, N-methylglucamine, citrate, ammonium salt, dihydrochloride, oleate, edetate, oxalate, edisylate, pamoate (embonate), estolate, palmitate, esylate, pantothenate, fumarate, phosphate/diphosphate, gluceptate, polygalacturonate, gluconate, salicylate, glutamate, stearate, glycollylarsanilate, sulfate, hexylresorcinate, subacetate, hydrabamine, succinate, hydrobromide, tannate, hydrochloride, tartrate, hydroxynaphthoate, teoclate, iodide, tosylate, isothionate, triethiodide, lactate, panoate, valerate, and the like which can be used as a

dosage form for modifying the solubility or hydrolysis characteristics, or can be used in sustained release or pro-drug formulations.

[0056] In a broader sense, the invention provides a method of treating cancer, using an alkaline salt solution prepared from a water-soluble, pharmaceutically acceptable organic acid. There is variability in the ionization capability of the salts of cesium and rubidium with some ionizing more readily than others.

[0057] Additionally, other cesium and rubidium salts might be used including various organic or metallic salts, preferably meeting the following requirements: (1) they should be pharmaceutically acceptable and have an acceptably low level of toxicity ; (2) they should allow the salt to be infused into the patient in a stable and slightly alkaline solution having a pH ranging between 7.30 to 7.45 in water or a buffered saline solution; (3) they should have sufficiently high levels of solubility in water or a buffered saline solution; and (4) they should have sufficiently high levels of cationic (alkaline) dissociation to allow the remaining negatively charged ions to effectively reduce the acidity levels of tumor pHe (micro- environment) and systemically eliminate metastasis.

[0058] The toxicity of the salts of cesium and rubidium will depend on the salt combinations. For example, carbonate, malate, chloride, citrate and sulfate salts are safer, the phosphate is relatively safe but may interact with calcium metabolism, while others have various levels of toxicity and should be used with caution. The organic species are as the organic acids are readily metabolized.

[0059] The invention employs an alkaline salt solution formed by the following chemical formula:"MA", where"MA"substantially dissociates in water solution to form"M+"and "A-"."M"is the alkali metal moiety, which may be cesium and or rubidium. "A"is the anionic moiety, which may be any compatible nontoxic inorganic species such as but not limited to chloride, sulfate, carbonate or phosphate etc.; or it may be any compatible organic species such as lactate, citrate or acetate, etc.

[0060] In the event that it is necessary to combine the alkali metal moiety with an anionic moiety, for example, the hydroxide of the alkali metal can be combined with the acid form of

the desired anion, thus:"MOH + HA = MA + H20". In the case of acids that can dissociate more than one hydrogen ion, the final product may be partially protonated, for example, "MHC02", the bicarbonate salt, or"M2CO2", the carbonate salt. The final formula can be designed by controlling the stoichiometry of the reaction or by any known manufacturing process to obtain the required final pH and ionic concentrations. For example, citric acid can be used to neutralize a solution of cesium hydroxide until a pH ranging between 7.20 and 7.50, and preferably ranging between 7. 31 and 7.42, is obtained, or precise amounts of cesium hydroxide can be mixed with predetermined amounts of acid so that on dissolution a predetermined physiologic pH range will be obtained. If tumor metabolism is monitored by lactate or lactate dehydrogenase (LDH) measurements, it may be preferable to avoid use of lactate to minimize background lactate or LDH signals. If salts of cesium or rubidium are not available then cesiumrubidium may be administered.

[0061] Secondary ingredients are chosen to complement or potentiate the action of the cesium and rubidium ions. Potentiation of cesium and or rubidium ionic therapy can be accomplished by inclusion of ingredients that enhance the shift towards apoptosis induced by ionic physiology. Examples are compounds that stimulate calcium accumulation, such as calcium supplements with potassium and magnesium, preferably in a 2 to 1 ratio, vitamin D3, selenium salts, calcitonin, calcium ionophores, etc. , compounds that defeat the elimination of sodium from cancer cells such as monensin or inhibitors of sodium/potassium exchange, compounds that alter pH regulating characteristics such as nigericin, amiloride and its derivatives, 4,4-diisothiocyanostilbene 2, 2-disulfonic acid and bafilomycin. Further examples are compounds that decrease glucose utilization by tumor cells, such as ionidamine, and compounds that independently increase the activation of apoptosis.

[0062] Another class of ingredients which potentiate the activity of the cesium and or rubidium ions are ingredients which stimulate or support the immune system and normal healthy viable cells, especially those which may be nutrient deficient as a secondary consequence of cancer, such as magnesium, zinc, vitamin B2 and B 12, ingredients that complement the salts of cesium and or rubidium therapy which may be useful in reducing

cancer viability. These include the wide variety of chemotherapies and immunotherapies that do not target ionic physiology. Additional classes of ingredients which complement the ionic action of rubidium and or cesium salts therapy are those which minimize the toxic effects of tumor necrosis. These include systemic hydration and internal cell hydration, other alkalizing treatments, treatments that reduce the toxicity of solid tumor necrosis and are nutritionally stimulating combined with dietary intervention, such as, carbohydrate restriction and supplementation appropriate to the physiological stress associated with cancer therapy or tumor necrosis. Additional classes of ingredients may complement the action of rubidium and or cesium salts and balanced electrolyte support such as potassium, magnesium and other mineral supplements, which compensate for potassium and other mineral losses which may occur at higher dosages. Mineral supplements including trace minerals and ions are also used to obtain and maintain the desired pH range of bodily fluids and proper cellular metabolism.

[0063] Compounds such as antibiotics with anti-viral, antifungal, and anti-mold activity may be included if appropriate. Chelation therapy to reduce or eliminate lead, mercury, cadmium, etc. may be included if appropriate. Enzyme therapy may be included if appropriate.

[0064] Cesium and rubidium salts in a crystalline form described herein are required for purposes such as storage or oral administration. The salts may be manufactured by conventional methods containing buffered salt or salts. The salt or salts may be orally administered without previous dissolution or they may be prepared as a pharmaceutical solution suitable for ingestion or injectable solutions in a sterile buffered saline solution isotonic to blood. For example, solutions for pharmaceutical injection should be prepared with a composition that renders the solutions pH ranging between 7.20 to 7.45.

[0065] The aqueous solution for oral administration may be from any pharmaceutical source. As an example, but not limited to, the method of manufacture is to use water processed by Electro-Chemical Activation (E. C. A. ) to process a variety of concentrations, altering the electro-viscous characteristics improving the impedance to improve internal cell hydration. The salts containing cesium and or rubidium ions may be introduced into the

solution, as an example, lowering the surface tension ranging between 40 to 68 dynes per cm2 and increasing the water bond angle ranging from 105° to 115°, preferably ranging <BR> <BR> between 110° to 114°, having an O. R. P. ranging from-250 m. v. to-700 m. v. , preferably-300 m. v. to-550 m. v.; the solution pH ranges between 8.00 to 9.80, preferably 8.60 to 9.30. l0066] METHOD OF USE [0067] The alkaline salt solution is administered to a cancer patient in sufficient quantities for injection into the blood circulation, a sufficient quantity of a suitable alkali (alkaline salt solution) such as, acid in water or saline buffer, e. g. Ringers solution administered by a suitable method such as, but not limited to, periodic injections, intravenous infusion, rectal, vaginal, nasogastric, transdermal application, peritoneal, subcutaneous, sublingual, intramuscular, intrathecal, use of an implanted osmotic mini-pump or other slow-release methods or devices, etc. The injected solution is isotonic to blood and has a pH ranging between 7.30 to 7. 44, preferably 7.37 to 7.42. Periodic injection or continuous intravenous infusion are preferred.

[0068] The active ingredients (drug) may take the form of gels, oils, bandages dressings, topical lotions, douche solutions, surgical irrigation solutions suppositories, colon irrigation solutions, or drop dispersions, encapsulation in liposomes, micro-particles, enteric coatings, micro capsules, transdermal patches, etc.

[0069] Formulations for oral administration may be presented in unit-dose or multi-dose containers, for example sealed ampoules and vials and may be presented as discrete units such as capsule, cachets or tablets each containing a predetermined amount of the ingredients; as a powder or granules; as a solution or a suspension in an aqueous liquid or a non-aqueous liquid; or as oil in water liquid emulsion or water in oil liquid emulsion. The formula may be presented as a bolus, electuary or paste.

[0070] In general, the prescribed dosage required for therapeutic efficacy in cancer patients will be dependent on such factors as the patient's saliva, urine, and blood pH, weight, age, nutritional background, gender, physical symptoms and condition, duration and frequency of administration, chosen route of administration, and the variety of cancer and its stage of

advancement.

[0071] The alkaline salts described herein can also be administered orally if desired, such as in liquid form, in a tablet or capsule, or as a food additive. If oral administration is used, the dosage should be in the ranging between 1,000 mg to 10,000 mg per 24 hrs.

[0072] The oral LD-50 for cesium citrate for a 70kg male is approximately 2.6 grams/kg or 182 grams. The salt or compound of the invention may be administered orally or via injection at a dose ranging from 1 to 100 mg/kg per 24 hours, preferably ranging from 3 to 50 mg/kg per 24 hours. Doses above 3 mg/kg per 24 hours may preferably be administered in a series of smaller doses over a prolonged period, i. e. by infusion over several hours. The dosage range for adults generally ranges between 2,000 mg to 10,000 mg per 24 hours, preferably 4,000 mg to 7,000 mg per 24 hours. Administration from tablets or other forms which is effective at such dosages or as a multiples of the same, for instance, discrete units containing 500 mg to 2,500 mg, preferably 750 mg to 2, 000 mg. As a general guide, the effective cancer dosage range for cesium is 0.1 to 5 mEq per kilogram per 24 hours for cancer therapy, 0.005 to 0.1 mEq per kilogram per 24 hrs. Doses over 1 mEq per kilogram should be used only for critical (life threatening) cases with careful monitoring for stress symptoms. Juvenile doses are generally l/2 of the adult range, depending on weight, etc.

[0073] The dosages are adjusted (increased or decreased) as therapy progresses. The presence of stress effects determine the dosage or amounts of cesium and or rubidium salts administered with balanced electrolyte support. The therapy is most effective if the diet is nutritionally stimulating and does not contribute to acidotic stress. Carbohydrate restriction is encouraged to limit acidosis. For example, dietary foods and beverages with a pH below 2.50 should be completely eliminated, or neutralized. Foods with a low glycemic index are preferred and foods with a pH of 3.00 or lower and beverages and foods whose low pH results from phosphoric acid should be minimized. A neutral or slightly alkaline diet should be maintained during the therapy. Oral fluid consumption should be primarily derived from E. C. A. processed alkaline water with balanced electrolytes and trace minerals with a pH ranging from 7.50 to 9.30, initially from 7.50 and gradually increasing the fluid pH to 9.00 to

9.30 during the therapy cycle.

[0074] The patient's tumor or tumors should be monitored, as well as vital signs. The patient's saliva, urine and blood pH should be monitored and the dosage adjusted accordingly. The goal of dosage adjustment is to partially or wholly restore the pHe levels to optimum, ranging from 7.36 to 7.44, preferably 7.40, during the therapy; both the pH of the fluid inside the tumor or tumors and the pH of blood emerging from a tumor should be monitored and other indicating features of ionic therapy such as tumor sodium, potassium, magnesium and calcium levels and metabolites such as lactate should be monitored. Further indications of controlled efficacy are tumor suppression (shrinkage), metastasis elimination and tumor necrosis. Dosages that result in restoration of physiologic pHe and in an optimum or near optimum, as opposed to cancerous, ionic response to glycolytic metabolism are indications of the effectiveness of the therapy. A lack of adequate response by the tumor pHe (micro environment) and other indicators suggests dehydration and or insufficient dosage.

[0075] Excessive doses of rubidium and cesium salts can cause physiological stress; examples are mild diuretic effects, potassium depletion, low blood pressure or excessive alkalization. In cases where maximal efficacy is required during cancer treatment, the upper dosage limit is set by the stress symptoms. The maximum dosage must be below the point at which perturbation of electrolyte balance causes damage. The pH ranges noted above for therapeutic efficacy will provide information useful for the physician in assessment of physiological stress. The patient is to be well hydrated before initiation of therapy.

Dehydration should be monitored and promptly corrected if it occurs. Blood pH should not rise above 7.45, the targeted saliva pH ranges from 7.00 to 7.55, more preferably 7.40 to 7.50, and should not rise above 7.70. The targeted urine pH is 7.00 and should not rise above 7.1 to 7.20 and only briefly rise above 7.50 or fall below 5.00 or, only very briefly below 4.50. Symptoms of excessive pH increase are muscle aches or excessive numbness around the mouth. Sensations of excessive numbness indicate incipient effects on nerve tissue's ionic status. This indicates the need for temporary reduction of the dosage to avoid excessive alkalosis-induced stress and requires an increased dosage of potassium and magnesium and

electrolyte support until the symptoms are reduced to an acceptable therapeutic level. Doses should not exceed those that cause very slight sensations of numbness on the upper lip during therapy. Blood potassium should not fall below tolerable levels. Blood pressure and serum creatine levels should be monitored.

[0076] Example 1. Use of cesium and rubidium salts for cancer suppression and remission of the tumor microenvironment by oral administration of an aqueous solution containing: Cesium citrate ranging from 1,500 mg per 24 hours to 10,000 mg per 24 hours, more preferably 5,000 mg to 6,000 mg per 24 hours; with balanced electrolytes and nutrient support, for example, potassium (as phosphate or acetate) 500-2000 mg; calcium 2,500 mg- 5000 mg; magnesium citrate 200-1500 mg; iodine 50-400 mcg.; selenium (Selenomethionine) 50-200 mcg; vanadium (vanadyl sulfate) 500 to 1,000 mcg; zinc gluconate 30-200 mg; vitamin D3 (cholecarciferol) 2,000 to 4,000 IU; vitamin A 2,000 to 5,000 IU; vitamin C (buffered L-ascorbic acid) 1,000 to 5,000 mg; malic acid 100-500 mg; coenzyme Q 10 (ubiquinone) 10-50 mg; vitamin B3 (methyl nicotinate) 10-30 mg; vitamin B6 (pyridoxine hydrochloride) 1-20 mg; vitamin B12 (cyanocobalamin) 20-50 mg.

[0077] Example 2. Use of cesium and rubidium salts, an aqueous pharmaceutical solution for slow intravenous infusion directly into the blood circulation for anti-metastasis and anti- neo-vascularization therapy. Dosage per 24 hours generally ranges between 2,000 mg to 10, 000 mg Cesium Citrate per liter, more preferably 2,500 mg to 3,000 mg per liter, in a buffered saline solution with balanced electrolytes made isotonic to blood, such as cesium citrate and rubidium citrate at the aforementioned concentrations may also be utilized. As an example, solution administered by continuous intravenous drip (2x) per 24 hours, generally ranging from 250 cc to 1000 cc as necessary. If the patient's physiological condition is life threatening such as comatose or terminal stage cancer, a higher dosage may be required, as an example, 1,000 cc two to three times per 24 hrs.

[0078] Example 3. Oral capsules or tablets containing powdered salts of cesium and or rubidium. For administration to patients who are at high risk of reoccurrence of cancer after remission or as a prophylactic dosage for cancer suppression. As an example, but not limited

to: cesium citrate 400 mg; rubidium citrate 100 mg; with balanced electrolytes including potassium (preferably as phosphate or acetate) 150 mg to 1200 mg; calcium 2,500 mg; magnesium citrate 200 mg to 1,500 mg. The dosage of salts containing cesium and or rubidium administered in discrete tablets or capsules are coadministered with alkaline water and a suitable carbohydrate. The dosages generally range between 250 mg to 1000 mg per 24 hours, preferably 125 mg to 500 mg per 24 hours with nutrient support, for example, iodine 150-400 mcg.; selenium (Selenomethionine) 50-200 mcg; vanadyl sulfate 250-1000 mcg; zinc gluconate 50-200 mg; vitamin D3 (cholecarciferol) 1,000 to 4,000 IU; vitamin A 2,000 to 5,000 IU ; buffered vitamin C- (L-ascorbic acid); 1,000 to 5,000 mg; malic acid 3-5 mg; co-enzyme Q 10 (ubiquinone) 25-50 mg; vitamin B3 (methyl nicotinate) 5-20 mg; vitamin B6 25-100 mg; vitamin B12 (cyanocobalamin) 20-50 mcg.

100791 The physician should monitor the patient's saliva and adjust the dosages to obtain and maintain the targeted saliva pH ranges, optimally 7.40 to 7.55, only briefly up to 7.7.

Monitoring the urine pH such that the targeted pH should not rise above 7.1 to 7.2 or drop below 5.0, only very briefly fall below 4.5. Stress monitoring may be indicated if there are medical conditions that may be exacerbated by the pH selective therapy such as conditions relating to compromised or abnormal mineral absorption or low blood pressure.

{0080] Example 4. Treatment of cancer by administering cesium and rubidium salts with balanced electrolytes in combination with other anti-cancer agents, to lessen the risk of causing cancer in normal healthy cells when radiation therapy is used to treat cancer cells, or reduce the suppression of the immune response that often occur in conventional cancer therapies.

[00811 The method and formula for tumor remission and suppression of cancer may be used either preceding or subsequent to one or more conventional cancer therapies such as but not limited to radiation, cobalt, x-ray, laetrile or cytotoxic treatment procedures. The first method of treatment procedure may be a radiation treatment, and the second treatment procedure may be the administration of cesium and or rubidium salts. Radiation treatments can proceed on a schedule in combination with the administration of the formula to provide

optimum results. Such scheduling of the treatment and procedures can be prescribed by the physician following routine medical evaluation. In addition to cesium and or rubidium salts formulations, the tumor or tumors also may be treated with one or more cytotoxic chemical compounds in a treatment.

[0082] The method for treating cancerous tumors may include a first treatment procedure using a wide variety conventional cancer treatment technique and a second treatment procedure which includes administering an effective amount of salts containing cesium and or rubidium with electrolytes. The first treatment procedure may be a treatment with one or more conventional cytotoxic chemical compounds. As examples, the cytotoxic chemical compound may be a nitrosourea, cyclophosphamide, adriamycin, 5-fluorouracil, paclitaxel and its derivatives, cisplatin or other cancer treating agents. The cytotoxic chemical compound and the cesium and or rubidium salts may be administered by any suitable delivery route. The first treatment procedure may take place prior to the second treatment procedure, after the second treatment procedure, or the two treatment procedures may take place simultaneously. In one example, the first treatment procedure (e. g. , discrete time intravenous dosage of cytotoxic chemical or chemicals) is completed before the second treatment procedure with cesium and or rubidium salts administration begins. As an alternative, the first treatment procedure may be a conventional radiation treatment regimen.

[0083] Example 5. Use of cesium and rubidium salts for surgical incision or wound irrigation. The treatment is administered to clean and irrigate a surgical wound, providing disinfecting, irrigation, and anti-metastasis activity and simultaneously promoting the healing cycle or otherwise sterilizing or treating the surgical wound. Treatment is initiated by washing or irrigating the incision or wound with a sterile, saline stream of fluid that may contain other antiseptic, antibiotic, or anesthetic solutions. The stream or flow is directed to the wound from a conventional medical type syringe or IV tubing. The irrigating fluid is splashed onto the incision or wound surface with a moderate amount of force sufficient to dislodge tumor debris, dead tissue, dirt, debris and bacteria and then collecting the fluids in a bag, or onto some absorbent disposable cotton bandages.

[0084] Example 6. Oral administration of salts containing cesium and rubidium for gene- stabilizing and repair or prophylactic therapy, with capsules or tablets of powdered salts containing cesium and or rubidium salts for cancer remission. This formulation is intended for use by patients who are at high genetic risk for the manifestation of cancer, as an example, or administering to cancer patients after therapy. Dosages range between 250 mg to 500 mg per 24 hrs, as an example, cesium malate 250 mg; potassium (preferably as phosphate, and or acetate) with balanced electrolytes and supportive nutrients. As an example, dietary foods and beverages with pH below 2.50 should be completely eliminated, or neutralized pH with a suitable form of calcium, etc. Oral fluid consumption should be primarily derived from alkaline water with a pH range from 7.50 to 9.30, preferably gradually increasing the pH of the fluids from 7.50 to 9.30. Foods with pH a below 3.00 and beverages and foods whose low pH results from phosphoric acid should be minimized. A neutral or slightly alkaline diet is maintained during the therapy. The patient should be monitored for stress and efficacy as described above, and the therapeutic doses adjusted to give a positive response with minimal stress. Failure to respond either initially or after a period of favorable response indicates that complementary or potentiating ingredients should be considered.

[0085] Example 7. Administration of salts of cesium and rubidium to encapsulate tumors infused into a patient over a continuous period such as several days in a row prior to cancer surgery to systemically encapsulate cancer (neoplasms) to more readily identify all the cancer cells (tumors) and remove as discrete lumps minimizing surgical trauma and postoperative complications and simplifying the surgical procedure and simultaneously eliminating the recurrence of malignant tumors and increasing the life expectancy of some patients.

[0086] The use of novel methods employing the formula of the present invention have qualities that will be appreciated as this application encompasses broader and other aspects than recited in these examples. The use of salts of cesium and or rubidium in treatment modalities is separate and distinct from the use in radiation therapy of man-made isotopes of cesium and or rubidium.

[0087] The foregoing disclosure is sufficient to enable one having skill in the art to practice the invention without undue experimentation, and provides the best mode of practicing the invention presently contemplated by the inventor. While there is provided herein a full and complete disclosure of the preferred embodiments of this invention, it is not intended to limit the invention to the exact construction, dimensional relationships, and operation shown and described. Various modifications, alternative constructions, changes and equivalents will readily occur to those skilled in the art and may be employed, as suitable, without departing from the true spirit and scope of the invention. Such changes might involve alternative materials, components, structural arrangements, sizes, shapes, forms, functions, operational features or the like.

[0088] Accordingly, the proper scope of the present invention should be determined only by the broadest interpretation of the appended claims so as to encompass all such modifications as well as all relationships equivalent to those described in the specification.