Claims for Patent: 9,745,567

Summary for Patent: 9,745,567

Title:	Compositions and methods for treating multiple sclerosis
Abstract:	Provided are electrokinetically-altered fluids (gas-enriched electrokinetic fluids) comprising an ionic aqueous solution of charge-stabilized oxygen-containing nanostructures in an amount sufficient to provide modulation of at least one of cellular membrane potential and cellular membrane conductivity, and therapeutic compositions and methods for use in treating inflammatory neurodegenerative condition or disease or at least one symptom thereof. The electrokinetically-altered fluids or therapeutic compositions and methods include electrokinetically-altered ioinic aqueous fluids optionally in combination with other therapeutic agents. Particular aspects provide for regulating or modulating intracellular signal transduction associated with said inflammatory responses by modulation of at least one of cellular membranes, membrane potential, membrane proteins such as membrane receptors, including but not limited to G-Protein Coupled Receptors (GPCR), and intercellular junctions (e.g., tight junctions, gap junctions, zona adherins and desmasomes). Other embodiments include particular routes of administration or formulations for the electrokinetically-altered fluids (e.g., electrokinetically-altered gas-enriched fluids and solutions) and therapeutic compositions.
Inventor(s):	Watson; Richard L. (McPherson, KS), Wood; Anthony B. (Dallas, TX), Archambeau; Gregory J. (Puyallap, WA)
Assignee:	REVALESIO CORPORATION (Tacoma, WA)
Application Number:	12/430,728
Patent Claims:	1. A method of alleviating symptoms of an inflammatory neurodegenerative condition or disease, comprising administering to a subject in need thereof a therapeutically effective amount of an oxygenated ionic aqueous solution of charge-stabilized oxygen-containing nanobubbles having an average diameter of less than 100 nanometers sufficient for alleviating symptoms of an inflammatory neurodegenerative condition or disease, said oxygenated ionic aqueous solution comprising sodium chloride, said oxygenated ionic aqueous solution oxygenated at a level of at least about 40 ppm oxygen, and wherein the inflammatory neurodegenerative condition or disease is a demyelinating disease of the subject's central nervous system. 2. The method of claim 1, wherein the charge-stabilized oxygen-containing nanobubbles have an average diameter of less than 90 nm. 3. The method claim 1, wherein the fluid comprises a form of solvated electrons. 4. The method of claim 1, wherein the inflammatory neurodegenerative condition or disease is multiple sclerosis. 5. The method of claim 1, wherein the oxygenated ionic aqueous solution modulates localized or cellular levels of nitric oxide. 6. The method of claim 1 wherein the electrokinetically altered aqueous fluid promotes a localized decrease of at least one cytokine selected from the group consisting of: IL-1beta, IL-8, TNF-alpha, and TNF-beta. 7. The method of claim 1, further comprising a synergistic or non-synergistic inhibition or reduction in inflammation by simultaneously or adjunctively treating the subject with another anti-inflammatory agent. 8. The method of claim 7, wherein said other anti-inflammatory agent comprises a steroid or glucocorticoid steroid. 9. The method of claim 8, wherein the glucocorticoid steroid comprises Budesonide or an active derivative thereof. 10. The method of claim 1, comprising combination therapy, wherein at least one additional therapeutic agent is administered to the patient. 11. The method of claim 10, wherein, the at least one additional therapeutic agent is selected from the group consisting of: glatiramer acetate, interferon-.beta., mitoxantrone, natalizumab, inhibitors of MMPs including inhibitor of MMP-9 and MMP-2, short-acting .beta..sub.2-agonists, long-acting .beta..sub.2-agonists, anticholinergics, corticosteroids, systemic corticosteroids, mast cell stabilizers, leukotriene modifiers, methylxanthines, .beta..sub.2-agonists, albuterol, levalbuterol, pirbuterol, artformoterol, formoterol, salmeterol, anticholinergics including ipratropium and tiotropium; corticosteroids including beclomethasone, budesonide, flunisolide, fluticasone, mometasone, triamcinolone, methyprednisolone, prednisolone, prednisone; leukotriene modifiers including montelukast, zafirlukast, and zileuton; mast cell stabilizers including cromolyn and nedocromil; methylxanthines including theophylline; combination drugs including ipratropium and albuterol, fluticasone and salmeterol, budesonide and formoterol; antihistamines including hydroxyzine, diphenhydramine, loratadine, cetirizine, and hydrocortisone; immune system modulating drugs including tacrolimus and pimecrolimus; cyclosporine; azathioprine; mycophenolatemofetil; and combinations thereof. 12. The method of claim 10, wherein the inflammatory neurodegenerative condition or disease is multiple sclerosis. 13. The method of claim 10, wherein the at least one additional therapeutic agent is a TSLP and/or TSLPR antagonist. 14. The method of claim 1, wherein the administration of the oxygenated aqueous fluid comprises administration to a cell network or layer of the subject, said cell network or layer comprising an intracellular junction, said administration further comprising modulation of the intercellular junction. 15. The method of claim 14, wherein the intercellular junction comprises at least one selected from the group consisting of tight junctions, gap junctions, zona adherins and desmasomes. 16. The method of claim 14, wherein the cell network or layers comprises at least one selected from the group consisting of endothelial cell and endothelial-astrocyte tight junctions in CNS vessels, blood-cerebrospinal fluid tight junctions or barrier, pulmonary epithelium-type junctions, bronchial epithelium-type junctions, and intestinal epithelium-type junctions. 17. The method of claim 1, wherein an ability of said oxygenated ionic aqueous solution to modulate of at least one of cellular membrane potential and cellular membrane conductivity persists for at least two months in a closed gas-tight container. 18. The method of claim 1, wherein the amount of oxygen present in the oxygenated ionic aqueous solution is at least 50 ppm at atmospheric pressure. 19. The method of claim 1, wherein the oxygenated ionic aqueous solution had an oxygen concentration of at least 50 ppm at the time it was generated. 20. The method of claim 1, wherein the oxygenated ionic aqueous solution is administered parenterally. 21. The method of claim 1, wherein the oxygenated ionic aqueous solution is administered by inhalation.

Details for Patent 9,745,567

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Biogen Inc.	TYSABRI	natalizumab	Injection	125104	11/23/2004		2039-02-26