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  Methods and compositions for ameliorating the undesirable effects of chemotherapyUSPTO Application #: 20060089313Title: Methods and compositions for ameliorating the undesirable effects of chemotherapy Abstract: In one aspect, the present invention provides chemoprotectant compositions that each comprise at least two of the chemoprotectants disclosed herein. The chemoprotectant compositions of the invention are useful, for example, for ameliorating at least one adverse effect of chemotherapy. In another aspect, the present invention provides methods of ameliorating at least one adverse effect of chemotherapy, the methods each comprising the step of administering to a subject undergoing chemotherapy an amount of a chemoprotectant composition that is effective to ameliorate at least one adverse effect of the chemotherapy. (end of abstract) Agent: Christensen, O'connor, Johnson, Kindness, PLLC - Seattle, WA, US Inventors: Jonathan Kil, Eric D. Lynch USPTO Applicaton #: 20060089313 - Class: 514018000 (USPTO) Related Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Designated Organic Active Ingredient Containing (doai), Peptide Containing (e.g., Protein, Peptones, Fibrinogen, Etc.) Doai, Cyclopeptides, 3 Or 4 Peptide Repeating Units In Known Peptide Chain The Patent Description & Claims data below is from USPTO Patent Application 20060089313. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS-REFERENCE TO RELATED APPLICATION [0001] This application claims the benefit of U.S. Provisional Application No. 60/334,140, filed Nov. 29, 2001. FIELD OF THE INVENTION [0002] The present invention relates to methods and compositions for ameliorating the undesirable effects of chemotherapy, such as chemotherapy that utilizes cisplatin. BACKGROUND OF THE INVENTION [0003] One approach to the treatment of cancer is chemotherapy in which one or more chemical substances that are toxic, or otherwise deleterious, to the cancerous cells are administered to an individual suffering from cancer. Unfortunately, most, if not all, chemotherapeutic agents cause undesirable effects that adversely affect the health of the patient. [0004] By way of example, the chemotherapeutic agent cisplatin (cis-diamminedichloroplatinum) is a heavy metal complex, with platinum as the central atom surrounded by two chloride atoms and two ammonia molecules in the cis position. Cisplatin produces interstrand and intrastrand crosslinkage in DNA of rapidly dividing cells, thus preventing DNA, RNA, and/or protein synthesis. [0005] Cisplatin is typically used (often in combination with other chemotherapeutic agents, such as paclitaxel, cyclophosphomide, vinblastine, doxorubicin and bleomycin) to treat patients having metastatic testicular tumors, metastatic ovarian tumors, carcinoma of the endometrium, bladder, head, or neck. Unfortunately, cisplatin causes numerous adverse effects, such as seizures, peripheral neuropathies, ototoxicity, hearing loss, deafness, vertigo, dizziness, blurred vision, nausea, vomiting, anorexia, diarrhea, constipation, myelosuppression, thrombocytopenia, anemia, neutropenia, and nephrotoxicity. [0006] Thus, there remains a need for compositions and methods that ameliorate or eliminate the undesirable effects of chemotherapy. In particular, there remains a need for compositions and methods that ameliorate or eliminate one or more, or all, of the undesirable effects of cisplatin chemotherapy. SUMMARY OF THE INVENTION [0007] In one aspect, the present invention provides chemoprotectant compositions that each comprise at least two of the chemoprotectants disclosed herein. The chemoprotectant compositions of the invention are useful, for example, for ameliorating at least one adverse effect of chemotherapy. [0008] In another aspect, the present invention provides pharmaceutical compositions that each include: (a) a chemoprotectant selected from the group consisting of methionine, N-acetyl-DL-methionine, S-adenosylmethionine, cysteine, homocysteine, cystathione, cysteamine, N acetylcysteine, glutathione, glutathione ethylester, glutathione diethylester, glutathione triethylester, cysteamine, DiNAC, RibCys, RibCyst, .beta.-LactCys, .alpha.-LactCys, MeliCys, MaltCys, CellCys, OTCA, allopurinol, 1-methylallopurinol, 2-methylallopurinol, 5-methylallopurinol, 7-methylallopurinol, 1,5-dimethylallopurinol, 2,5-dimethylallopurinol, 1,7-dimethylallopurinol, 2,7-dimethylallopurinol, 5,7-dimethylallopurinol, 2,5,7-trimethylallopurinol, 1-ethoxycarbonylallopurinol, 1-ethoxycarbonyl-5-methylallopurinol, 2-phenyl-1,2-benzoisoselenazol-3(2H)-one, and 6-diSeCD; and (b) a chemotherapeutic agent. [0009] In another aspect, the present invention provides methods of ameliorating at least one adverse effect of chemotherapy, the methods each comprising the step of administering to a subject undergoing chemotherapy an amount of a chemoprotectant composition that is effective to ameliorate at least one adverse effect of the chemotherapy. The chemoprotectant composition comprises one or more (such as at least two) of the chemoprotectants disclosed herein. BRIEF DESCRIPTION OF THE DRAWINGS [0010] The foregoing aspects and many of the attendant advantages of this invention will become more readily appreciated as the same become better understood by reference to the following detailed description, when taken in conjunction with the accompanying drawings, wherein: [0011] FIG. 1 shows a plot of the percentage of live, cultured, NuTu-19 ovarian cancer cells versus concentration of cisplatin in the culture medium. The number of live cells was measured after culturing the cells for 24 hours in the presence of cisplatin. [0012] FIG. 2 shows a plot of the percentage of live, cultured, NuTu-19 ovarian cancer cells versus the concentration (in units of .mu.M) of N-acetyl-cysteine (NAC) in the culture medium. The viability of NuTu-19 cells cultured in the presence of N-acetylcysteine, but not in the presence of cisplatin, is shown by the upper graph. The viability of NuTu-19 cells cultured in the presence of both N-acetylcysteine and cisplatin (at a concentration of 43 .mu.M) is shown by the lower graph. [0013] FIG. 3 shows a plot of the percentage of live, cultured, NuTu-19 ovarian cancer cells versus the concentration of Ebselen in the culture medium. The viability of NuTu-19 cells cultured in the presence of Ebselen, but not in the presence of cisplatin, is shown by the upper graph. The viability of NuTu-19 cells cultured in the presence of both Ebselen and cisplatin (at a concentration of 43 .mu.M) is shown by the lower graph. [0014] FIG. 4 shows a plot of the percentage of live, cultured, NuTu-19 ovarian cancer cells versus the concentration of allopurinol in the culture medium. The viability of NuTu-19 cells cultured in the presence of allopurinol, but not in the presence of cisplatin, is shown by the upper graph. The viability of NuTu-19 cells cultured in the presence of both allopurinol and cisplatin (at a concentration of 43 .mu.M) is shown by the lower graph. [0015] FIG. 5 shows a plot of the percentage of live, cultured, NuTu-19 ovarian cancer cells versus the concentration of N-acetylcysteine in the culture medium. The viability of NuTu-19 cells cultured in the presence of N-acetylcysteine and Ebselen (at a concentration of 47 .mu.M), but not in the presence of cisplatin, is shown by the upper graph. The viability of NuTu-19 cells cultured in the presence of N-acetylcysteine, Ebselen (at a concentration of 47 .mu.M) and cisplatin (at a concentration of 43 .mu.M) is shown by the lower graph. [0016] FIG. 6 shows a plot of the percentage of live, cultured, NuTu-19 ovarian cancer cells versus the concentration of allopurinol in the culture medium. The viability of NuTu-19 cells cultured in the presence of allopurinol and Ebselen (at a concentration of 47 .mu.M), but not in the presence of cisplatin, is shown by the upper graph. The viability of NuTu-19 cells cultured in the presence of allopurinol and Ebselen (at a concentration of 47 .mu.M) and cisplatin (at a concentration of 43 .mu.M) is shown by the lower graph. [0017] FIG. 7 shows a graph showing the number of inner ear hair cells in rat cochlea that were cultured, in vitro, in the presence of 43 .mu.M cisplatin (10), or 43 .mu.M cisplatin plus 47 .mu.M Ebselen (12), or 47 .mu.M Ebselen (14). [0018] FIG. 8 shows the permanent threshold shift (PTS) in hearing at 8 kHz, 16 kHz, 24 kHz and 32 kHz of rats treated with saline and DMSO (vehicle control) (20), or with cisplatin (at a dosage of 16 mg/kg body weight) in the presence of Ebselen (at a dosage of 16 mg/kg body weight) (22). Ten cochlea were tested per treatment. [0019] FIG. 9 shows the permanent threshold shift (PTS) in hearing at 8 kHz, 16 kHz, 24 kHz and 32 kHz of rats treated with cisplatin (at a dosage of 16 mg/kg body weight) in the presence of allopurinol (at a dosage of 16 mg/kg body weight)(30), or in the presence of the combination of allopurinol (at a dosage of 8 mg/kg body weight) and Ebselen (at a dosage of 8 mg/kg body weight)(32). Four cochlea were tested per treatment. Continue reading... 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