A Phase II Multicenter, Double-Blind, Placebo-Controlled, Trial of VLTS-589 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease

The purpose of this study is to evaluate the safety and tolerability of VLTS-589 compared with placebo, administered bilaterally to the lower extremities, in subjects with intermittent claudication and to determine the effect of VLTS-589 in peak walking time (PWT) for subjects receiving VLTS-589 compared with subjects receiving placebo.

开始日期2003-06-01

申办/合作机构

Valentis

100 项与 Del-1 gene therapy(Valentis, Inc.) 相关的临床结果

登录后查看更多信息

100 项与 Del-1 gene therapy(Valentis, Inc.) 相关的转化医学

登录后查看更多信息

100 项与 Del-1 gene therapy(Valentis, Inc.) 相关的专利（医药）

登录后查看更多信息

项与 Del-1 gene therapy(Valentis, Inc.) 相关的文献（医药）

2007-05-01·American Heart Journal2区 · 医学

Results from a phase II multicenter, double-blind placebo-controlled study of Del-1 (VLTS-589) for intermittent claudication in subjects with peripheral arterial disease

2区 · 医学

Article

作者: Neal Kleiman ; Marc Litt ; David E. Kandzari ; Jeffery Snell ; Jorge F. Saucedo ; Timothy D. Henry ; R. David Anderson ; Ronald Karlsberg ; Daniel Gottlieb ; James B. Hermiller ; Farrell Mendelsohn ; Robert J. Weiss ; Paul Michael Grossman ; Krishna Rocha-Singh

BACKGROUNDThis study compared VLTS-589 (plasmid encoding the angiomatrix protein Del-1 in conjunction with poloxamer 188) with poloxamer 188 control, for the treatment of intermittent claudication in patients with moderate to severe peripheral arterial disease.METHODSSubjects with bilateral intermittent claudication and peak walking time (PWT) between 1 and 10 minutes on 2 qualifying (reproducible; within 25% of each other) treadmill tests were enrolled. Patients received VLTS-589 or poloxamer 188 control, administered as 21 intramuscular injections to each lower extremity (42 mL in each extremity). In addition to safety and tolerability, efficacy evaluations compared to baseline included the following: change in PWT at 90 days (primary end point), change in claudication onset time, change in ankle brachial index (ABI), and change in quality of life measures.RESULTSA total of 105 patients were randomized and treated. During the 30, 90, and 180 days follow-up, mean PWT, claudication onset time, and ABI were significantly increased compared to baseline values in both treatment groups with no significant difference between groups in the primary or secondary end points. In addition, both groups demonstrated significantly improved quality of life at follow-up vs baseline, with no significant differences between groups. Serious adverse events were similar in both groups--none were definitely treatment-related.CONCLUSIONIntramuscular delivery of both Del-1 expressing plasmid and the control resulted in significant improvement in exercise capacity compared to baseline at 30, 90, and 180 days. There was no difference in outcome measures associated with the Del-1 plasmid.

2004-06-01·Human Gene Therapy2区 · 医学

Design of the Del-1 for Therapeutic Angiogenesis Trial (DELTA-1), a Phase II Multicenter, Double-Blind, Placebo-Controlled Trial of VLTS-589 in Subjects with Intermittent Claudication Secondary to Peripheral Arterial Disease

2区 · 医学

Article

作者: Erikson, Marlena ; Annex, Brian H. ; Grossman, Paul M. ; Hiatt, William R. ; Mendelsohn, Farrell O. ; Regensteiner, Judith G. ; Olin, Jeffrey W. ; Rajagopalan, Sanjay ; Young, Stuart

The objective of this phase II investigation is to assess the safety and efficacy of a plasmid mediated approach to induce angiogenesis/arteriogenesis with the angiomatrix protein Del-1 (developmentally regulated endothelial locus 1), in subjects with intermittent claudication (IC) secondary to peripheral arterial disease (PAD). VLTS-589 is an investigational nonviral therapeutic comprising a plasmid-expressing Del-1 formulated with poloxamer 188 (facilitating agent). One hundred subjects with bilateral PAD and IC will be randomized after careful screening to bilateral intramuscular delivery of VLTS-589 or placebo. A total of 84 mg of plasmid or placebo will be delivered as 42 intramuscular injections (2 ml per injection, 21 injections or 42 ml in each extremity of either plasmid or placebo) in both lower extremities. The subjects in the study will be followed at regular intervals for a year after study drug administration (days 30, 90, 180, and 365) with the primary endpoint being the safety and tolerability of VLTS-589 and change in peak walking time (PWT) at day 90. The secondary endpoints include percent and absolute change in resting ankle brachial Index, claudication onset time, and quality of life measured at various time points. DELTA-1 represents the largest plasmid-based gene transfer trial designed to test the efficacy of a Del-1 as a therapeutic approach in patients with IC caused by PAD. The novel aspects of the protocol include the usage of a Del-1 plasmid-polaxamer formulation to enhance gene transfer at doses that are an order of magnitude different than other comparable trials in a unique bilateral intramuscular dosing pattern to maximize transfection/clinical efficacy and general applicability to patients with PAD.

100 项与 Del-1 gene therapy(Valentis, Inc.) 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
间歇性跛行	临床2期	美国	Valentis	2003-06-01
心肌缺血	临床2期	-	Valentis, Inc.	-
外周动脉疾病	临床2期	-	Valentis, Inc.	-
外周动脉疾病	临床2期	-	Valentis, Inc.	-

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ASGCT2003 人工标引	临床1期	外周动脉疾病	20	VLTS-589	(蓋簾構衊糧選鑰壓廠觸) = no serious adverse events attributable to VLTS-589 had been noted in this study 構齋憲鹹齋膚築夢衊選 (構選鏇選觸壓衊網鹹築 )	积极	2003-05-01