MDGN-201(MDGN-201) - 药物靶点：EPO receptor_专利_临床

概要

基本信息

药物类型

基因疗法

别名

Epodure、Erythropoietin gene therapy、MDGN 201 TARGTepo secreting EPO

+ [2]

靶点

EPO receptor

作用机制

EPO receptor调节剂(促红细胞生成素受体调节剂)

治疗领域

神经系统疾病内分泌与代谢疾病血液及淋巴系统疾病+ [1]

在研适应症-

非在研适应症

肾性贫血终末期肾脏病帕金森病

原研机构

Aevi Genomic Medicine, Inc.

在研机构-

非在研机构

Aevi Genomic Medicine, Inc.Medgenics Medical (Israel) Ltd.

最高研发阶段终止临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

3

项与 MDGN-201 相关的临床试验

NCT02468414 / Terminated临床2期

Safety & Efficacy of Prolonged Physiologic EPO Level Treatment of Anemia in ESRD Patients Undergoing Peritoneal Dialysis Using MDGN201 TARGTEPO

The objectives of this study are to assess safety and to evaluate the biologic activity of TARGTEPO treatment in Peritoneal Dialysis patients

开始日期2015-06-01

申办/合作机构

Aevi Genomic Medicine, Inc.

[+1]

NCT02378662 / Terminated临床2期

Safety & Efficacy of Prolonged Physiologic Erythropoietin (EPO) Level Treatment of Anemia in End Stage Renal Disease (ESRD) Patients Undergoing Peritoneal Dialysis (PD)Using MDGN201 TARGTEPO

The objectives of this study are to assess safety and to evaluate the biologic activity of TARGTEPO treatment in Peritoneal Dialysis patients

开始日期2015-04-01

申办/合作机构

Aevi Genomic Medicine, Inc.

[+1]

NCT02117427 / Completed临床1/2期

Safety and Efficacy of Sustained Erythropoietin Therapy of Anemia in Chronic Kidney Disease (CKD) Patients and End-Stage Renal Disease (ESRD) Dialysis Patients Using MDGN201 TARGTEPO

The objectives of this study are to assess safety and to evaluate the biologic activity of TARGTEPO treatment.

开始日期2014-05-27

申办/合作机构

Aevi Genomic Medicine, Inc.

[+1]

100 项与 MDGN-201 相关的临床结果

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100 项与 MDGN-201 相关的转化医学

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100 项与 MDGN-201 相关的专利（医药）

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1

项与 MDGN-201 相关的文献（医药）

2012-03-01·Nature Medicine1区 · 医学

New blood-boosting drugs aim to staunch renal anemia

1区 · 医学

作者: Moyer, Melinda Wenner

Peginesatide, if approved, would be available only to patients on dialysis, who comprise 380,000 of the 26 million people in the US with chronic kidney disease.So, companies are working towards developing broader-reaching anemia therapies, too.One such strategy involves gene therapy.For example, the US-Israeli biopharmaceutical company Medgenics is advancing a cell-based erythropoietin gene therapy, called Epodure, for predialysis patients.The treatment involves harvesting a sliver of tissue from beneath a person′s skin, transducing it with an adenovirus engineered to express the gene encoding erythropoietin and then implanting the altered tissue back into participants several weeks later.In early clin. data presented in Nov. at the American Society of Nephrol.′s Kidney Week meeting in Philadelphia, the company reported that treatment with Epodure provided more than six months of elevated Hb levels in around half of the trial participants, with the longest effect maintained 30 mo out from treatment.By far the least intrusive therapy would be a pill to treat renal anemia, and San Francisco-based FibroGen is working toward that goal.The company has developed an oral drug that ramps up production of endogenous erythropoietin by stabilizing hypoxia-inducible factor 1α (HIF1α), a protein required for its expression.Although the company abandoned its first HIF1α stabilizer in 2007 after a study participant died of liver failure, preliminary results from an ongoing phase 2 trial look promising.In data announced at last year′s Kidney Week meeting, the company′s second-generation mol., FG-4592, proved more effective and safer than the original.One lingering concern with FibroGen′s approach is that HIF1α affects a number of biol. pathways, not just the production of red blood cells.So, researchers are still waiting on longer-term data to gauge whether the mol. causes any "unintended or undesirable consequences beyond stimulating erythropoiesis," notes Jeffrey Berns, a nephrologist at the University of Pennsylvania Perelman School of Medicine in Philadelphia.Still, the idea that individuals with anemia could one day replace injections with a pill is exciting, Choi says. "We′re going to be waiting with bated breath."

100 项与 MDGN-201 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
帕金森病	临床2期	美国	Medgenics Medical (Israel) Ltd.	2015-06-01
帕金森病	临床2期	美国	Aevi Genomic Medicine, Inc.	2015-06-01
肾性贫血	临床2期	以色列	Aevi Genomic Medicine, Inc.	2015-04-01
肾性贫血	临床2期	以色列	Medgenics Medical (Israel) Ltd.	2015-04-01
终末期肾脏病	临床2期	以色列	Medgenics Medical (Israel) Ltd.	2015-04-01
终末期肾脏病	临床2期	以色列	Aevi Genomic Medicine, Inc.	2015-04-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02378662 (CTgov)	临床2期	肾性贫血 \| 终末期肾脏病	2	MDGN201 TARGTEPO (Group A)	醖襯膚鹹繭齋蓋鹹齋醖(壓築醖顧鏇艱顧網窪衊) = 選築簾構鹹壓觸顧鹹艱鏇構艱願遞膚鬱蓋衊鬱 (廠醖鹽餘衊艱鏇製範膚, 憲獵淵廠憲鑰網鹹築憲 ~ 鬱鏇蓋鏇餘觸繭齋醖齋) 更多	-	2018-10-19
				MDGN201 TARGTEPO (Group B)	醖襯膚鹹繭齋蓋鹹齋醖(壓築醖顧鏇艱顧網窪衊) = 選積鑰鹽壓廠襯觸餘簾鏇構艱願遞膚鬱蓋衊鬱 (廠醖鹽餘衊艱鏇製範膚, 艱蓋築鬱積繭窪簾醖夢 ~ 積淵憲選構觸廠選網鹹) 更多