Edifoligide sodium(Edifoligide sodium) - 药物靶点：E2F1_专利_临床

概要

基本信息

药物类型

TF Decoy

别名

E2F decoy ODN、E2F duplex decoy、E2F transcription factor decoy

+ [7]

靶点

E2F1

作用方式

抑制剂

作用机制

E2F1抑制剂(转录因子E2F1抑制剂)

治疗领域

心血管疾病其他疾病泌尿生殖系统疾病

在研适应症-

非在研适应症

动脉闭塞性疾病冠心病血管移植物阻塞+ [4]

原研机构

Anesiva, Inc.

在研机构-

非在研机构

Anesiva, Inc.

权益机构-

最高研发阶段终止临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构/序列

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Sequence Code 29359050

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Sequence Code 29883143

来源: *****

关联

3

项与 Edifoligide sodium 相关的临床试验

NCT00086164

/ Terminated临床1/2期

A Phase 1/2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Pilot Trial to Assess the Effect of Treatment of the Recipient Vein of a Polytetrafluoroethylene (PTFE) Vascular Access Graft With Two Concentrations of E2F Decoy as Compared to Placebo on Neointimal Hyperplasia and the Preservation of Graft Function in Patients With Chronic Renal Failure Requiring Hemodialysis

The purpose of this study is to determine the effect of recipient vein pretreatment of edifoligide (E2F Decoy), compared to placebo, on graft/recipient vein stenosis in polytetrafluoroethylene (PTFE) vascular access grafts placed for hemodialysis at 6 months after enrollment.

开始日期2004-05-01

申办/合作机构

Anesiva, Inc.

NCT00042081

/ Completed临床3期

A Phase III, Multi-Center Randomized, Double-Blind, Placebo-Controlled Trial of the Ex Vivo Treatment With CGT003 of Coronary Vein Grafts in Patients Undergoing Coronary Artery Bypass Graft Procedures

The purpose of this study is to determine the efficacy of graft pretreatment with CGT003 (E2F Duplex Decoy), as compared to placebo, on the incidence of patients experiencing vein graft failure after coronary artery bypass surgery.

开始日期2002-07-01

申办/合作机构

Anesiva, Inc.

NCT00041925

/ Completed临床2/3期

A Phase III, Multi-Center Randomized, Double-Blind, Placebo-Controlled Trial of the Ex Vivo Treatment With CGT003 of Peripheral Vein Grafts in Patients Undergoing Peripheral Arterial Bypass Graft Procedures

The purpose of this study is to determine the efficacy of graft pretreatment with the E2F decoy, CGT003, as compared to placebo, on the occurrence of graft failure among patients who receive autogenous vein grafts to treat chronic critical limb ischemia; on the occurrence of clinically significant graft stenosis (more than or equal to 70%); and on the incidence of critical limb ischemia (e.g., gangrene, non-healing ischemic ulcers or ischemic rest pain).

开始日期2001-11-01

申办/合作机构

Anesiva, Inc.

100 项与 Edifoligide sodium 相关的临床结果

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100 项与 Edifoligide sodium 相关的转化医学

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100 项与 Edifoligide sodium 相关的专利（医药）

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49

项与 Edifoligide sodium 相关的文献（医药）

2018-07-01·Circulation. Cardiovascular interventions

Frailty for Critical Limb Ischemia

Communications

作者: Shishehbor, Mehdi H. ; Li, Jun

See Article by Takeji et al Critical limb ischemia (CLI), despite advancements in revascularization technology and technical approaches, continues to be associated with significant morbidity and mortality.1–3 Although most operators consider endovascular approach as the first-line therapy for CLI,2–5 controversy remains as to which approach (medical, endovascular, or surgical) is optimal. Classic considerations in the decision between endovascular versus surgical revascularization have been operator experience, anatomy, availability of conduit, age, and patient comorbidities. Meanwhile, those who are bedridden with or without severe dementia have usually been treated with medical therapy only or major amputation. The ultimate goal for CLI is to provide a therapy that would minimize suffering and allow independent ambulation. Accordingly, many risk scores, including BASIL (Bypass versus Angioplasty in Severe Ischemia of the Leg), PREVENT III (Edifoligide for the Prevention of Infrainguinal Vein Graft Failure), and FINNVASC (Finland National Vascular), have been developed to help in these decisions, but none are widely used. These risk scores, while informative, only provide data on measured comorbidities and lack information on other important risk factors, such as nutritional status, physical fitness, inflammation, degree of tissue loss, and overall health status of the patients. Therefore, a prognostic instrument that could potentially capture these unmeasured confounders would be of significant value in helping physicians and patients make proper treatment decisions and set appropriate expectations. To this end, Yamaji et al6 examined the prognostic value of frailty in patients with CLI. This current study6 adds to the growing body of literature to identify frailty as a potential prognostic measure in patients undergoing revascularization for CLI. The authors prospectively evaluated patients who presented with Rutherford classification IV-VI symptoms and risk-stratified them based on the clinical frailty scale. Clinical follow-up at 2 years demonstrated that those with …

2016-07-01·Journal of vascular surgery2区 · 医学

Validation of the Wound, Ischemia, foot Infection (WIfI) classification system in nondiabetic patients treated by endovascular means for critical limb ischemia

2区 · 医学

Article

作者: Stavroulakis, Konstantinos ; Stachmann, Arne ; Beropoulis, Efthymios ; Bisdas, Theodosios ; Torsello, Giovanni ; Schwindt, Arne

BACKGROUND:

The Society for Vascular Surgery Lower Extremity Guidelines Committee developed the Wound, Ischemia, foot Infection (WIfI) a classification system to predict the amputation risk in patients with critical limb ischemia (CLI). A number of published studies have already evaluated its prognostic value. However, most of the included patients were diabetic, and the validation was done independent of the revascularization procedure. This single-center study evaluated the prognostic value of WIfI stages in nondiabetic patients treated by endovascular means.

METHODS:

A retrospective analysis was performed of prospectively collected data of nondiabetic patients treated by endovascular means between January 2013 and September 2014. All patients were classified according to their wound status, ischemia index, and extent of foot infection to four classes: very low risk, low risk, moderate risk, and high risk. Comorbidities and vascular lesions for each group were analyzed. The prognostic value of WIfI was analyzed based on the amputation-free survival, overall survival rate, and freedom from amputation at 12 months.

RESULTS:

Data from 302 CLI patients treated in the study period were reviewed. A total of 219 patients (73%) underwent an endovascular intervention, and among them, 126 nondiabetic patients (58%) were enrolled in this study. Most patients were classified as low risk (33%), and the prevalence of very low-risk, moderate-risk, and very high-risk patients was 23%, 23%, and 21%, respectively. The modified Edifoligide for the Prevention of Infrainguinal Vein Graft Failure (PREVENT III) score was statistically significantly higher in the high-risk group (5.2 ± 2.4) than in the very low-risk, low-risk, and moderate-risk groups (4.3 ± 2.5, 3.5 ± 2.3, 4.5 ± 2.2, respectively; P = .048). One major amputation (1%) was performed during the hospital stay in a high-risk patient. Mean follow-up was 14 ± 8 months. The amputation-free survival at 12 months was 87%, 81%, 81%, and 62%, in the very low-risk, low-risk, moderate risk, and very high-risk groups, respectively (P = .106). The difference was statistically significant between the very low-risk and high-risk groups (hazard ratio, 3.4; 95% confidence interval, 1.1-10.3; P = .029). A similar trend was also observed for 1-year survival between the very low-risk and the high-risk groups (87%, 84%, 81%, 65%; P = .166). The amputation rate during the follow-up time was 0%, 2% (n = 6), 3% (n = 5), and 12% (n = 9) for the very low-risk, low-risk, moderate-risk, and very high-risk groups, respectively (P = .033).

CONCLUSIONS:

The WIfI classification system predicted the amputation risk and survival in this highly selected group of nondiabetic CLI patients treated by endovascular means, with a statistically significant difference between very low-risk and high-risk patients already at 1 year.

2015-12-01·Journal of vascular surgery2区 · 医学

Objective performance goals after endovascular intervention for critical limb ischemia

2区 · 医学

Article

作者: Davies, Mark G ; El-Sayed, Hosam F

OBJECTIVE:

During the last decade, primary endoluminal therapy for critical limb ischemia (CLI), assessed as rest pain and tissue loss of the lower extremity, has significantly increased. Reporting of patient-centered outcomes using the new Society for Vascular Surgery objective performance goals (OPGs) has been limited. This study examined the OPGs for infrainguinal endovascular management of CLI.

METHODS:

A prospective database of patients undergoing endovascular treatment of the lower extremity for CLI between 2000 and 2011 was queried. Evaluated were clinical efficacy (absence of recurrent symptoms, maintenance of ambulation and absence of major amputation), amputation-free survival (survival without major amputation), and freedom from major adverse limb events (MALEs; above-ankle amputation of the index limb or major reintervention - new bypass graft, jump/interposition graft revision).

RESULTS:

A total of 728 patients (60% male; age, 68 ± 14 years) underwent lower extremity interventions for CLI (66% tissue loss); of these, 39% had superficial femoral artery and tibial interventions. Diabetes mellitus was present in 71%, hyperlipidemia in 64%, and chronic renal insufficiency in 37%. Technical success was 96%. The overall rate at 30 days of major adverse cardiovascular events (MACEs) was 3% and MALEs was 12%. At 5 years, clinical efficacy was (mean ± standard error of the mean) 42% ± 5%, amputation-free survival was 41% ± 7%, and freedom from MALEs was 51% ± 4%. Clinical efficacy was significantly different in those presenting with rest pain and tissue loss and in the anatomic high-risk group compared with the clinical high-risk group, and both were worse compared with the group without clinical or high-risk criteria.

CONCLUSIONS:

Endoluminal therapy for CLI is associated with early low MACE rates but high MALE rates. When the key outcome of amputation free survival is considered, predictors of a better outcome were absence of current smoking, a lower modified Edifoligide for the Prevention of Infrainguinal Vein Graft Failure (PREVENT III) amputation risk score, better preoperative ambulation status, lower MACEs, and discharge disposition to home. The presence of tissue loss and anatomic risk factors negatively affect outcomes. Longer-term outcomes after endovascular intervention for CLI remain relatively poor, with <40% success in objective performance outcomes at 5 years.

100 项与 Edifoligide sodium 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03949	-	-	DB06556

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
冠心病	临床3期	美国	Anesiva, Inc.	2002-07-01
动脉闭塞性疾病	临床3期	加拿大	Anesiva, Inc.	2001-11-01
血管移植物阻塞	临床3期	美国	Anesiva, Inc.	2001-11-01
血管移植物阻塞	临床3期	加拿大	Anesiva, Inc.	2001-11-01
增生	临床3期	美国	Anesiva, Inc.	2001-11-01
增生	临床3期	加拿大	Anesiva, Inc.	2001-11-01
缺血	临床3期	美国	Anesiva, Inc.	2001-11-01
缺血	临床3期	加拿大	Anesiva, Inc.	2001-11-01
外周血管疾病	临床3期	美国	Anesiva, Inc.	2001-11-01
外周血管疾病	临床3期	加拿大	Anesiva, Inc.	2001-11-01

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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


NCT00042081 (PREVENT IV, Pubmed \| Am Heart J)	临床3期	-	-	Edifoligide	餘衊網醖襯餘襯鏇鬱鹽(窪範壓鑰顧憲壓醖範獵) = 願壓積鬱網醖製繭膚繭鏇範觸顧鹽構鹹窪餘糧 (醖構願遞網繭網獵鹽廠 ) 更多	-	2012-09-01
				Placebo	餘衊網醖襯餘襯鏇鬱鹽(窪範壓鑰顧憲壓醖範獵) = 醖醖遞鑰製餘襯鏇餘醖鏇範觸顧鹽構鹹窪餘糧 (醖構願遞網繭網獵鹽廠 ) 更多
NCT00042081 (Prevent IV, Pubmed \| JAMA)	临床3期	冠状动脉旁路移植术并发症	3,014	Edifoligide	淵鏇製醖鏇淵壓選構簾(遞襯願構簾窪淵壓廠鹽) = 範淵築範繭築糧觸淵鬱膚鏇衊繭淵選繭鑰網繭 (膚築鹽製遞構築網齋選 ) 更多	不佳	2005-11-16
				Placebo	淵鏇製醖鏇淵壓選構簾(遞襯願構簾窪淵壓廠鹽) = 鏇構鹽觸廠構範簾廠製膚鏇衊繭淵選繭鑰網繭 (膚築鹽製遞構築網齋選 ) 更多