Faculty Collaboration Database

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. Am Heart J 2007 May;153(5):874-80

Date

04/25/2007

Pubmed ID

17452167

DOI

10.1016/j.ahj.2007.01.038

Scopus ID

2-s2.0-34247353352 (requires institutional sign-in at Scopus site)   77 Citations

Abstract

BACKGROUND: This 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.

METHODS: Subjects 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.

RESULTS: A 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.

CONCLUSION: Intramuscular 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.

Author List

Grossman PM, Mendelsohn F, Henry TD, Hermiller JB, Litt M, Saucedo JF, Weiss RJ, Kandzari DE, Kleiman N, Anderson RD, Gottlieb D, Karlsberg R, Snell J, Rocha-Singh K

Author

Jorge Saucedo MD Chief, Professor in the Medicine department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adult
Aged
Aged, 80 and over
Ankle
Blood Pressure
Brachial Artery
Calcium-Binding Proteins
Carrier Proteins
Cell Adhesion Molecules
Double-Blind Method
Exercise Tolerance
Female
Genetic Therapy
Genetic Vectors
Humans
Injections, Intramuscular
Intermittent Claudication
Male
Middle Aged
Peripheral Vascular Diseases
Plasmids
Quality of Life
Treatment Outcome
Walking