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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.AH

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.

Authors+Show Affiliations

University of Michigan Healthcare System, Ann Arbor, MI 48109-0311, USA. pagross@umich.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17452167

Citation

Grossman, Paul Michael, et al. "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." American Heart Journal, vol. 153, no. 5, 2007, pp. 874-80.
Grossman PM, Mendelsohn F, Henry TD, et al. 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;153(5):874-80.
Grossman, P. M., Mendelsohn, F., Henry, T. D., Hermiller, J. B., Litt, M., Saucedo, J. F., Weiss, R. J., Kandzari, D. E., Kleiman, N., Anderson, R. D., Gottlieb, D., Karlsberg, R., Snell, J., & Rocha-Singh, K. (2007). 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. American Heart Journal, 153(5), 874-80.
Grossman PM, et al. 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;153(5):874-80. PubMed PMID: 17452167.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Grossman,Paul Michael, AU - Mendelsohn,Farrell, AU - Henry,Timothy D, AU - Hermiller,James B, AU - Litt,Marc, AU - Saucedo,Jorge F, AU - Weiss,Robert J, AU - Kandzari,David E, AU - Kleiman,Neal, AU - Anderson,R David, AU - Gottlieb,Daniel, AU - Karlsberg,Ronald, AU - Snell,Jeffery, AU - Rocha-Singh,Krishna, PY - 2006/08/19/received PY - 2007/01/29/accepted PY - 2007/4/25/pubmed PY - 2007/5/23/medline PY - 2007/4/25/entrez SP - 874 EP - 80 JF - American heart journal JO - Am. Heart J. VL - 153 IS - 5 N2 - 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. SN - 1097-6744 UR - https://www.unboundmedicine.com/medline/citation/17452167/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-8703(07)00154-8 DB - PRIME DP - Unbound Medicine ER -