JP-2022532766-A5 -

Dates

Publication Date

20230516

Application Date

20200515

Description

[Invention 1001]A method for treating a patient having familial adenomatous polyposis (FAP), comprising the step of administering to the patient a pharmaceutical therapy comprising a concomitant effective amount of eflornithine and sulindac, wherein the patient has at least a partially intact lower gastrointestinal tract.[Invention 1002]A method for delaying or preventing FAP events and/or FAP progression in a patient having familial adenomatous polyposis (FAP), comprising the step of administering to the patient a pharmaceutical therapy comprising a concomitant effective dose of eflornithine and sulindac, wherein the patient has at least a partially intact lower gastrointestinal tract.[Invention 1003]The method of the present invention 1001 or 1002, wherein the patient has an intact lower gastrointestinal tract.[Invention 1004]A method according to the present invention 1001 or 1002 for delaying the progression of FAP disease in the aforementioned patient.[Invention 1005]A method according to the present invention 1001 or 1002 that delays the need for colon surgery.[Invention 1006]A method according to the present invention 1001 or 1002 for preventing the need for colon surgery.[Invention 1007]A method according to the present invention 1001 or 1002 that delays the need for surgical intervention.[Invention 1008]A method according to the present invention 1001 or 1002 for preventing the need for surgical intervention.[Invention 1009]A method according to the present invention 1001 or 1002 for preventing the development of an adenoma.[Invention 1010]A method according to the present invention 1001 or 1002 for delaying the development of an adenoma.[Invention 1011]The method of the present invention 1010, wherein the adenoma is a high-risk adenoma.[Invention 1012]A method according to the present invention 1001 or 1002 for delaying the progression of polyposis.[Invention 1013]The method of the present invention 1012, which delays the need for endoscopic or surgical resection.[Invention 1014]A method according to the present invention 1001 or 1002 for preventing the progression of polyposis.[Invention 1015]The method of the present invention 1014 for preventing the need for endoscopic or surgical resection.[Invention 1016]A method according to the present invention 1001 or 1002 for delaying the formation of colorectal cancer in the aforementioned patient.[Invention 1017]A method according to the present invention 1001 or 1002 for preventing the formation of colorectal cancer in the aforementioned patient.[Invention 1018]The method according to any one of items 1001 to 1017 of the present invention, wherein the patient has an intact lower gastrointestinal tract including the colon, rectum, and ileal pouch.[Invention 1019]Any method of the present invention 1001 to 1018, wherein the patient's genotype is determined at position +263 (rs2302616) of at least one allele of the ODC1 gene.[Invention 1020]The method according to any one of items 1001 to 1019 of the present invention, wherein the genotype of the patient is determined to have T at position +263 (rs2302616) of at least one allele of the ODC1 gene.[Invention 1021]The method according to any one of the present invention 1001 to 1020, wherein the genotype of the patient is determined to have T at position +263 (rs2302616) of both alleles of the ODC1 gene.[Invention 1022]The method according to any one of the present invention 1001 to 1021, wherein the genotype of the patient is determined to have T at position +263 (rs2302616) of one allele of the ODC1 gene and G at position +263 (rs2302616) of one allele of the ODC1 gene.[Invention 1023]The method according to any one of items 1001 to 1022 of the present invention, wherein the genotype of the patient is determined at position +316 (rs2302615) of at least one allele of the ODC1 gene.[Invention 1024]The method according to any one of items 1001 to 1023 of the present invention, wherein the genotype of the patient is determined to have a G at position +316 (rs2302615) of at least one allele of the ODC1 gene.[Invention 1025]The method according to any one of the present invention 1001 to 1024, wherein the genotype of the patient is determined to have G at position +316 (rs2302615) of both alleles of the ODC1 gene.[Invention 1026]The method according to any one of the present invention 1001 to 1025, wherein the genotype of the patient is determined to have G at position +316 (rs2302615) of one allele of the ODC1 gene and A at position +316 (rs2302615) of one allele of the ODC1 gene.[Invention 1027]A method of preventing or reducing the risk of ototoxicity in the aforementioned patient, as described in any of the invention 1023 to 1026.[Invention 1028]Any method 1001 to 1027 of the present invention, wherein eflornithine is eflornithine hydrochloride.[Invention 1029]The method of the present invention 1028, wherein eflornithine hydrochloride is eflornithine hydrochloride monohydrate.[Invention 1030]The method of