Claims for Patent: 10,105,389

Summary for Patent: 10,105,389

Title:	Method and compositions for treating cancerous tumors
Abstract:	The present invention relates to the use of chlorine dioxide compositions for treating cancerous tumors. The present invention relates to compositions and methods for treating cancerous tumors, including naive, metastatic and recurrent cancers. The compositions comprise chlorine dioxide in an effective amount, which is injected into the cancerous tumor at least once, and often at least several times over the course of treatment. The chlorine dioxide compositions are injected directly into the cancerous tumor and the resulting tumor is effectively eliminated from the patient or subject over a period of one to several days to a few weeks, often after a single injection, or multiple injections at one session into the tumor. Often, an initial injection or multiple injections at one session are sufficient to dissolve the cancerous tumor. Often the cancer is eliminated (as evidenced by no remission) in a period of no more than several days to about two-three months and does not recur.
Inventor(s):	Alliger; Howard (Melville, NY)
Assignee:
Application Number:	15/475,704
Patent Claims:	1. A method of treating a cancerous tumor in a patient or subject in need comprising administering an effective amount of a composition comprising a solution of chlorine dioxide stabilized with urea, thiourea or monomethylurea wherein said composition is administered directly into the tumor to be treated. 2. The method according to claim 1 wherein said stabilized chlorine dioxide solution comprises urea or thiourea. 3. The method according to claim 1 wherein said stabilized chlorine dioxide solution comprises urea. 4. The method according to claim 3 wherein said stabilized chlorine dioxide solution is prepared by combining a chlorite solution and urea in solution, mixing thoroughly to provide a mixed chlorite/urea solution and adding an acid to the chlorite urea solution, mixing thoroughly to provide a chlorite/urea/acid final solution and allowing the final solution to clarify to provide the stabilized chlorine dioxide solution. 5. The method according to claim 1 wherein said chlorine dioxide composition is an aqueous solution of chlorine dioxide. 6. The method according to claim 1 wherein said chlorine dioxide composition is a gelled solution of chlorine dioxide. 7. The method according to claim 6 wherein said gelled solution comprises glycerin in an effective amount as the gelling agent. 8. The method according to claim 1 wherein said method comprises administering said chlorine dioxide composition a single time directly into said cancerous tumor. 9. The method according to claim 8 wherein said method comprising injecting said composition directly into the core of the cancerous tumor. 10. The method according to claim 1 wherein said method comprises administering said chlorine dioxide composition in multiple sites in the cancerous tumor. 11. The method according to claim 1 wherein said method comprises administering said chlorine dioxide composition throughout said cancerous tumor. 12. The method according to claim 1 wherein said cancerous tumor is a cancer selected from the group consisting of carcinoma, lymphoma, melanoma and sarcoma. 13. The method according to claim 1 wherein said cancerous tumor is a squamous-cell carcinoma, adenocarcinoma, hepatocellular carcinoma or a renal cell carcinoma. 14. The method according to claim 1 wherein said cancerous tumor is a cancer of the bladder, bowel, breast, cervix, colon, esophagus, head, kidney, liver, lung, neck, ovary, pancreas, prostate, or stomach, Burkitt's lymphoma, Non-Hodgkin's lymphoma, melanoma, Ewing's sarcoma, hemangiosarcoma, Kaposi's sarcoma, liposarcoma, myosarcomas, peripheral neuroepithelioma, synovial sarcoma, glioma, astrocytoma, oligodendroglioma, ependymoma, gliobastoma, neuroblastoma, ganglioneuroma, ganglioglioma, medulloblastoma, a pineal cell tumor, meningioma, meningeal sarcomas, neurofibroma, Schwannoma. 15. The method according to claim 1 wherein said cancerous tumor is bowel cancer, breast cancer, prostate cancer, cervical cancer, uterine/endometrial cancer, lung cancer, ovarian cancer, testicular cancer, thyroid cancer, esophageal cancer, pancreatic cancer, stomach cancer, liver cancer, colon cancer, melanoma, Hodgkin's disease, Wilms' tumor and teratocarcinoma. 16. The method according to claim 1 wherein said treatment is combined with radiation therapy. 17. The method according to claim 1 wherein said composition is co-administered with at least one additional anticancer agent. 18. The method according to claim 17 wherein said additional anticancer agent is an antimetabolite, an inhibitor of topoisomerase I and II, an alkylating agent, a microtubule inhibitor or a mixture thereof. 19. The method according to claim 17 wherein said additional anticancer agent is everolimus, trabectedin, abraxane, TLK 286, AV-299, DN-101, pazopanib, GSK690693, RTA 744, ON 0910.Na, AZD 6244 (ARRY-142886), AMN-107, TKI-258, GSK461364, AZD 1152, enzastaurin, vandetanib, ARQ-197, MK-0457, MLN8054, PHA-739358, R-763, AT-9263, a FLT-3 inhibitor, a VEGFR inhibitor, an EGFR TK inhibitor, an aurora kinase inhibitor, a PIK-1 modulator, a Bcl-2 inhibitor, an HDAC inhbitor, a c-MET inhibitor, a PARP inhibitor, a Cdk inhibitor, an EGFR TK inhibitor, an IGFR-TK inhibitor, an anti-HGF antibody, a PI3 kinase inhibitors, an AKT inhibitor, a JAK/STAT inhibitor, a checkpoint-1 or 2 inhibitor, a focal adhesion kinase inhibitor, a Map kinase kinase (mek) inhibitor, a VEGF trap antibody, pemetrexed, erlotinib, dasatanib, nilotinib, decatanib, panitumumab, amrubicin, oregovomab, Lep-etu, nolatrexed, azd2171, batabulin, ofatumumab (Arzerra), zanolimumab, edotecarin, tetrandrine, rubitecan, tesmilifene, oblimersen, ticilimumab, ipilimumab, gossypol, Bio 111, 131-I-TM-601, ALT-110, BIO 140, CC 8490, cilengitide, gimatecan, IL13-PE38QQR, INO 1001, IPdR.sub.1 KRX-0402, lucanthone, LY 317615, neuradiab, vitespan, Rta 744, Sdx 102, talampanel, atrasentan, Xr 311, romidepsin, ADS-100380, sunitinib, 5-fluorouracil, vorinostat, etoposide, gemcitabine, doxorubicin, irinotecan, liposomal doxorubicin, 5'-deoxy-5-fluorouridine, vincristine, temozolomide, ZK-304709, seliciclib; PD0325901, AZD-6244, capecitabine, L-Glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]- benzoyl]-, disodium salt, heptahydrate, camptothecin, PEG-labeled irinotecan, tamoxifen, toremifene citrate, anastrazole, exemestane, letrozole, DES(diethylstilbestrol), estradiol, estrogen, conjugated estrogen, bevacizumab, IMC-1C11, CHIR-258,); 3-[5-(methylsulfonylpiperadinemethyl)-indolylj-quinolone, vatalanib, AG-013736, AVE-0005, the acetate salt of [D-Ser(But) 6,Azgly 10] (pyro-Glu-His-Trp-Ser-Tyr-D-Ser(But)-Leu-Arg-Pro-Azgly-NH.sub.2 acetate [C.sub.59H.sub.84N.sub.18Oi.sub.4-(C.sub.2H.sub.4O.sub.2).sub.x where x=1 to 2.4], goserelin acetate, leuprolide acetate, triptorelin pamoate, medroxyprogesterone acetate, hydroxyprogesterone caproate, megestrol acetate, raloxifene, bicalutamide, flutamide, nilutamide, megestrol acetate, CP-724714; TAK-165, HKI-272, erlotinib, lapatanib, canertinib, ABX-EGF antibody, erbitux, EKB-569, PKI-166, GW-572016, lonafarnib, BMS-214662, tipifarnib; amifostine, NVP-LAQ824, suberoyl analide hydroxamic acid, valproic acid, trichostatin A, FK-228, SU11248, sorafenib, KRN951, aminoglutethimide, arnsacrine, anagrelide, L-asparaginase, Bacillus Calmette-Guerin (BCG) vaccine, bleomycin, buserelin, busulfan, carboplatin, carmustine, chlorambucil, cisplatin, cladribine, clodronate, cyproterone, cytarabine, dacarbazine, dactinomycin, daunorubicin, diethylstilbestrol, epirubicin, fludarabine, fludrocortisone, fluoxymesterone, flutamide, gemcitabine, gleevac, hydroxyurea, idarubicin, ifosfamide, imatinib, leuprolide, levamisole, lomustine, mechlorethamine, melphalan, 6-mercaptopurine, mesna, methotrexate, mitomycin, mitotane, mitoxantrone, nilutamide, octreotide, oxaliplatin, pamidronate, pentostatin, plicamycin, porfimer, procarbazine, raltitrexed, rituximab, streptozocin, teniposide, testosterone, thalidomide, thioguanine, thiotepa, tretinoin, vindesine, 13-cis-retinoic acid, phenyialanine mustard, uracil mustard, estramustine, altretamine, floxuridine, 5-deooxyuridine, cytosine arabinoside, 6-mecaptopurine, deoxycoformycin, calcitriol, valrubicin, mithramycin, vinblastine, vinorelbine, topotecan, razoxin, marimastat, COL-3, neovastat, BMS-275291, squalamine, endostatin, SU5416, SU6668, EMD121974, interleukin-12, IM862, angiostatin, vitaxin, droloxifene, idoxyfene, spironolactone, finasteride, cimitidine, trastuzumab, denileukin diftitox, gefitinib, bortezimib, paclitaxel, irinotecan, topotecan, doxorubicin, docetaxel, vinorelbine, bevacizumab (monoclonal antibody) and erbitux, cremophor-free paclitaxel, epithilone B, BMS-247550, BMS-310705, droloxifene, 4-hydroxytamoxifen, pipendoxifene, ERA-923, arzoxifene, fulvestrant, acolbifene, lasofoxifene, idoxifene, TSE-424, HMR-3339, ZK186619, PTK787/ZK 222584, VX-745, PD 184352, rapamycin, 40-O-(2-hydroxyethyl)-rapamycin, temsirolimus, AP-23573, RAD001, ABT-578, BC-210, LY294002, LY292223, LY292696, LY293684, LY293646, wortmannin, ZM336372, L-779,450, PEG-filgrastim, darbepoetin, erythropoietin, granulocyte colony-stimulating factor, zolendronate, prednisone, cetuximab, granulocyte macrophage colony-stimulating factor, histrelin, pegylated interferon alfa-2a, interferon alfa-2a, pegylated interferon alfa-2b, interferon alfa-2b, azacitidine, PEG-L-asparaginase, lenalidomide, gemtuzumab, hydrocortisone, interleukin-11, dexrazoxane, alemtuzumab, all-transretinoic acid, ketoconazole, interleukin-2, megestrol, immune globulin, nitrogen mustard, methylprednisolone, ibritgumomab tiuxetan, androgens, decitabine, hexamethylmelamine, bexarotene, tositumomab, arsenic trioxide, cortisone, editronate, mitotane, cyclosporine, liposomal daunorubicin, Edwina-asparaginase, strontium 89, casopitant, netupitant, an NK-1 receptor antagonists, palonosetron, aprepitant, diphenhydramine, hydroxyzine, metoclopramide, lorazepam, alprazolam, haloperidol, droperidol, dronabinol, dexamethasone, methylprednisolone, prochlorperazine, granisetron, ondansetron, dolasetron, tropisetron, pegfilgrastim, erythropoietin, epoetin alfa, darbepoetin alfa or a mixture thereof. 20. A method of treating a cancerous tumor in a patient or subject in need comprising administering into the tumor an effective amount of a chlorine dioxide composition comprising chlorine dioxide in an amount ranging from about 5 parts per million to about 1,000 parts per million, urea in an amount ranging from about 5 parts per million to about 50,000 parts per million and an acid effective to lower the pH of the composition to less than 4.5. 21. The method according to claim 20 wherein said composition is injected directly into the core of the tumor. 22. The method according to claim 20 wherein said composition is injected into multiple sites of the tumor. 23. The method according to claim 20 wherein said composition is injected throughout said tumor.

Details for Patent 10,105,389

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Recordati Rare Diseases, Inc.	ELSPAR	asparaginase	For Injection	101063	01/10/1978		2036-04-01
Merck Teknika Llc	TICE BCG	bcg live	For Injection	102821	06/21/1989		2036-04-01
Merck Teknika Llc	N/A	bcg vaccine	For Injection	103050	06/21/1989		2036-04-01
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	For Injection	103132	06/04/1986		2036-04-01
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	For Injection	103132			2036-04-01