Methods of using smad7 antisense oligonucleotides based on biomarker expression 机翻标题: 暂无翻译,请尝试点击翻译按钮。

公开号/公开日
WO2017055611 A2 2017-04-06 [WO201755611]WO2017055611 A9 2017-07-27 [WO201755611]WO2017055611 A3 2017-08-31 [WO201755611] / 2017-04-062017-07-272017-08-31
申请号/申请日
2016WO-EP73518 / 2016-09-30
发明人
BELLINVIA SALVATORE;MONTELEONE GIOVANNI;BARDEN HORAN GERALD SCOTT;
申请人
CELGENE;CELGENE ALPINE INVEST;NOGRA PHARMA;
主分类号
IPC分类号
A61K-031/712A61P-001/00C12N-015/113G01N-033/50
摘要
(WO201755611) Described herein are methods of treating inflammatory bowel disease (IBD) in a patient having IBD using SMAD7 antisense oligonucleotides.
机翻摘要
暂无翻译结果,您可以尝试点击头部的翻译按钮。
地址
代理人
代理机构
;
优先权号
2015US-62235556 2015-09-30
主权利要求
(WO201755611) 1. A method for treating or managing inflammatory bowel disease (IBD) in a patient having IBD, wherein the method comprises (a) analyzing a first level of Interleukin-5 (IL-5) in the patient; (b) administering to the patient an initial dose of a SMAD7 antisense oligonucleotide (AON); (c) analyzing a second level of IL-5 in the patient after the administering step; and wherein: i. if the second level of IL-5 is the same or higher than the first level of IL-5, then: administering to the patient a subsequent dose that is equal to or greater than the initial dose, and/or administering to the patient a subsequent dose at an equal or higher frequency than the initial dose; or ii. if the second level of IL-5 is lower than the first level of IL-5, then administering to the patient a subsequent dose that is equal to or smaller than the initial dose, and/or administering to the patient a subsequent dose at an equal or lower frequency than the initial dose.  4. A method for treating or managing IBD in a patient having IBD, wherein the method comprises (a) administering to the patient an initial dose of a SMAD7 AON; (b) analyzing the level of IL-5 in the patient after the administering step; and wherein i. if the level of IL-5 is above normal levels of IL-5, then administering to the patient a subsequent dose that is greater than or equal to the initial dose, and/or administering to the patient a subsequent dose at an equal or higher frequency than the initial dose; or ii. if the level of IL-5 is below normal levels of IL-5, then administering to the patient a subsequent dose that is equal to or smaller than the initial dose and/or administering to the patient a subsequent dose at an equal or lower frequency than the initial dose.  7. A method for treating or managing inflammatory bowel disease (IBD) in a patient having IBD, wherein the method comprises (a) analyzing the base level of IL-5 in the patient; and (b) if the base level of IL-5 is above normal levels of IL-5, then administering to the patient an initial dose of a SMAD7 AON.  64. A method for treating or managing IBD in a patient with IBD having above normal IL-5 levels following administration of a dose of a SMAD7 AON, said method comprising administering to said patient a further dose of said oligonucleotide that is greater than or equal to the prior dose.  65. A method for treating or managing IBD in a patient with IBD having below normal IL-5 levels following administration of a dose of SMAD7 AON, said method comprising administering to said patient a further dose of said oligonucleotide that is less than or equal to the prior dose.  66. A method of treating or managing IBD in a patient with IBD having above normal IL-5 levels, said method comprising administering to said patient a dose of a SMAD7 AON.  77. A method of monitoring the treatment or management of IBD in a patient with IBD, the method comprising analyzing IL-5 levels in the patient following each SMAD7 AON administration, wherein the absence of a decrease in IL-5 levels indicates that the treatment or management is not effective.  80. A method of treating or managing IBD in a patient with IBD having above normal levels of IL-5, comprising increasing the amount of a SMAD7 AON administered to the patient until IL-5 levels in the patient decrease.  82. A SMAD7 AON for use in a method for treating or managing IBD in a patient having IBD, wherein the method comprises analyzing the level of IL-5 in the patient to determine appropriate levels of SMAD7 AON administration.  84. A SMAD7 AON for use in a method for treating or managing IBD in a patient having IBD, wherein the method comprises (a) analyzing the level of IL-5 in the patient; and (b) if the level of IL-5 is above normal levels of IL-5, then administering to the patient an initial dose of the SMAD7 AON.  85. A method for treating or managing inflammatory bowel disease (IBD) in a patient having IBD, wherein the method comprises (a) analyzing a first level of IL-13 in the patient; (b) administering to the patient an initial dose of a SMAD7 AON; (c) analyzing a second level of IL- 13 in the patient after the administering step; and wherein: i. if the second level of IL-13 is the same or higher than the first level of IL-13, then: administering to the patient a subsequent dose that is equal to or greater than the initial dose, and/or administering to the patient a subsequent dose at an equal or higher frequency than the initial dose; or ii. if the second level of IL-13 is lower than the first level of IL-13, then administering to the patient a subsequent dose that is equal to or smaller than the initial dose, and/or administering to the patient a subsequent dose at an equal or lower frequency than the initial dose.  88. A method for treating or managing IBD in a patient having IBD, wherein the method comprises (a) administering to the patient an initial dose of a SMAD7 AON; (b) analyzing the level of IL-13 in the patient after the administering step; and wherein i. if the level of IL-13 is above normal levels of IL-13, then administering to the patient a subsequent dose that is greater than or equal to the initial dose, and/or administering to the patient a subsequent dose at an equal or higher frequency than the initial dose; or ii. if the level of IL-13 is below normal levels of IL-13, then administering to the patient a subsequent dose that is equal to or smaller than the initial dose and/or administering to the patient a subsequent dose at an equal or lower frequency than the initial dose.  91. A method for treating or managing inflammatory bowel disease (IBD) in a patient having IBD, wherein the method comprises (a) analyzing the base level of IL-13 in the patient; and (b) if the base level of IL-13 is above normal levels of IL-13, then administering to the patient an initial dose of a SMAD7 AON.  148. A method for treating or managing IBD in a patient with IBD having above normal IL-13 levels following administration of a dose of a SMAD7 AON, said method comprising administering to said patient a further dose of said oligonucleotide that is greater than or equal to the prior dose.  149. A method for treating or managing IBD in a patient with IBD having below normal IL-13 levels following administration of a dose of SMAD7 AON, said method comprising administering to said patient a further dose of said oligonucleotide that is less than or equal to the prior dose.  150. A method of treating or managing IBD in a patient with IBD having above normal IL-13 levels, said method comprising administering to said patient a dose of a SMAD7 AON.  161. A method of monitoring the treatment or management of IBD in a patient with IBD, the method comprising analyzing IL-13 levels in the patient following each SMAD7 AON administration, wherein the absence of a decrease in IL-13 levels indicates that the treatment or management is not effective.  164. A method of treating or managing IBD in a patient with IBD having above normal levels of IL-13, comprising increasing the amount of a SMAD7 AON administered to the patient until IL-13 levels in the patient decrease.  166. A SMAD7 AON for use in a method for treating or managing IBD in a patient having IBD, wherein the method comprises analyzing the level of IL-13 in the patient to determine appropriate levels of SMAD7 AON administration.  168. A SMAD7 AON for use in a method for treating or managing IBD in a patient having IBD, wherein the method comprises (a) analyzing the level of IL-13 in the patient; and (b) if the level of IL-13 is above normal levels of IL-13, then administering to the patient an initial dose of the SMAD7 AON.  169. A method for treating or managing inflammatory bowel disease (IBD) in a patient having IBD, wherein the method comprises (a) analyzing a first level of IL-25 in the patient; (b) administering to the patient an initial dose of a SMAD7 AON; (c) analyzing a second level of IL- 25 in the patient after the administering step; and wherein: i. if the second level of IL-25 is the same or higher than the first level of IL-25, then: administering to the patient a subsequent dose that is equal to or greater than the initial dose, and/or administering to the patient a subsequent dose at an equal or higher frequency than the initial dose; or ii. if the second level of IL-25 is lower than the first level of IL-25, then administering to the patient a subsequent dose that is equal to or smaller than the initial dose, and/or administering to the patient a subsequent dose at an equal or lower frequency than the initial dose.  172. A method for treating or managing IBD in a patient having IBD, wherein the method comprises (a) administering to the patient an initial dose of a SMAD7 AON; (b) analyzing the level of IL-25 in the patient after the administering step; and wherein i. if the level of IL-25 is above normal levels of IL-25, then administering to the patient a subsequent dose that is greater than or equal to the initial dose, and/or administering to the patient a subsequent dose at an equal or higher frequency than the initial dose; or ii. if the level of IL-25 is below normal levels of IL-25, then administering to the patient a subsequent dose that is equal to or smaller than the initial dose and/or administering to the patient a subsequent dose at an equal or lower frequency than the initial dose.  175. A method for treating or managing inflammatory bowel disease (IBD) in a patient having IBD, wherein the method comprises (a) analyzing the base level of IL-25 in the patient; and (b) if the base level of IL-25 is above normal levels of IL-25, then administering to the patient an initial dose of a SMAD7 AON.  232. A method for treating or managing IBD in a patient with IBD having above normal IL-25 levels following administration of a dose of a SMAD7 AON, said method comprising administering to said patient a further dose of said oligonucleotide that is greater than or equal to the prior dose.  233. A method for treating or managing IBD in a patient with IBD having below normal IL-25 levels following administration of a dose of SMAD7 AON, said method comprising administering to said patient a further dose of said oligonucleotide that is less than or equal to the prior dose.  234. A method of treating or managing IBD in a patient with IBD having above normal IL-25 levels, said method comprising administering to said patient a dose of a SMAD7 AON.  245. A method of monitoring the treatment or management of IBD in a patient with IBD, the method comprising analyzing IL-25 levels in the patient following each SMAD7 AON administration, wherein the absence of a decrease in IL-25 levels indicates that the treatment or management is not effective.  248. A method of treating or managing IBD in a patient with IBD having above normal levels of IL-25, comprising increasing the amount of a SMAD7 AON administered to the patient until IL-25 levels in the patient decrease.  250. A SMAD7 AON for use in a method for treating or managing IBD in a patient having IBD, wherein the method comprises analyzing the level of IL-25 in the patient to determine appropriate levels of SMAD7 AON administration.  252. A SMAD7 AON for use in a method for treating or managing IBD in a patient having IBD, wherein the method comprises (a) analyzing the level of IL-25 in the patient; and (b) if the level of IL-25 is above normal levels of IL-25, then administering to the patient an initial dose of the SMAD7 AON.  253. A method for treating or managing inflammatory bowel disease (IBD) in a patient having IBD, wherein the method comprises (a) analyzing a first level of REG3a in the patient; (b) administering to the patient an initial dose of a SMAD7 AON; (c) analyzing a second level of REG3a in the patient after the administering step; and wherein: i. if the second level of REG3a is the same or higher than the first level of REG3a, then: administering to the patient a subsequent dose that is equal to or greater than the initial dose, and/or administering to the patient a subsequent dose at an equal or higher frequency than the initial dose; or ii. if the second level of REG3a is lower than the first level of REG3a, then administering to the patient a subsequent dose that is equal to or smaller than the initial dose, and/or administering to the patient a subsequent dose at an equal or lower frequency than the initial dose.  256. A method for treating or managing IBD in a patient having IBD, wherein the method comprises (a) administering to the patient an initial dose of a SMAD7 AON; (b) analyzing the level of REG3a in the patient after the administering step; and wherein i. if the level of REG3a is above normal levels of REG3a, then administering to the patient a subsequent dose that is greater than or equal to the initial dose, and/or administering to the patient a subsequent dose at an equal or higher frequency than the initial dose; or ii. if the level of REG3a is below normal levels of REG3a, then administering to the patient a subsequent dose that is equal to or smaller than the initial dose and/or administering to the patient a subsequent dose at an equal or lower frequency than the initial dose.  259. A method for treating or managing inflammatory bowel disease (IBD) in a patient having IBD, wherein the method comprises (a) analyzing the base level of REG3a in the patient; and (b) if the base level of REG3a is above normal levels of REG3a, then administering to the patient an initial dose of a SMAD7 AON.  316. A method for treating or managing IBD in a patient with IBD having above normal REG3a levels following administration of a dose of a SMAD7 AON, said method comprising administering to said patient a further dose of said oligonucleotide that is greater than or equal to the prior dose.  317. A method for treating or managing IBD in a patient with IBD having below normal REG3a levels following administration of a dose of SMAD7 AON, said method comprising administering to said patient a further dose of said oligonucleotide that is less than or equal to the prior dose.  318. A method of treating or managing IBD in a patient with IBD having above normal REG3a levels, said method comprising administering to said patient a dose of a SMAD7 AON.  329. A method of monitoring the treatment or management of IBD in a patient with IBD, the method comprising analyzing REG3a levels in the patient following each SMAD7 AON administration, wherein the absence of a decrease in REG3a levels indicates that the treatment or management is not effective.  332. A method of treating or managing IBD in a patient with IBD having above normal levels of REG3a, comprising increasing the amount of a SMAD7 AON administered to the patient until REG3a levels in the patient decrease.  334. A SMAD7 AON for use in a method for treating or managing IBD in a patient having IBD, wherein the method comprises analyzing the level of REG3a in the patient to determine appropriate levels of SMAD7 AON administration.  336. A SMAD7 AON for use in a method for treating or managing IBD in a patient having IBD, wherein the method comprises (a) analyzing the level of REG3a in the patient; and (b) if the level of REG3a is above normal levels of REG3a, then administering to the patient an initial dose of the SMAD7 AON.
法律状态
(WO201755611) LEGAL DETAILS FOR WO2017055611  Actual or expected expiration date=2019-03-30    Legal state=ALIVE    Status=PENDING     Event publication date=2016-09-30  Event code=WO/APP  Event indicator=Pos  Event type=Examination events  Application details  Application country=WO WOEP2016073518  Application date=2016-09-30  Standardized application number=2016WO-EP73518     Event publication date=2017-04-06  Event code=WO/A2  Event type=Examination events  International application published with declaration under Article 17 (2) (a)  Publication country=WO  Publication number=WO2017055611  Publication stage Code=A2  Publication date=2017-04-06  Standardized publication number=WO201755611     Event publication date=2017-07-27  Event code=WO/A9  Event indicator=Pos  Event type=Examination events  International application or ISR republished with corrections, alterations  Publication country=WO  Publication number=WO2017055611  Publication stage Code=A9  Publication date=2017-07-27  Standardized publication number=WO201755611     Event publication date=2017-08-31  Event code=WO/A3  Event indicator=Pos  Event type=Examination events  Later publication of ISR with revised front page  Publication country=WO  Publication number=WO2017055611  Publication stage Code=A3  Publication date=2017-08-31  Standardized publication number=WO201755611
专利类型码
A2A9A3
国别省市代码
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