A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-Selection Study of Ad2/Hypoxia Inducible Factor (HIF)-1a/VP16 in Patients with Intermittent Claudication. (WALK)

Basic data for this project

Description

This Phase 2 gene transfer study will look at whether different doses of Ad2/HIF-1a/VP16 can be tolerated safely by direct injection into the leg muscles when the blood flow is not sufficient to meet the oxygen demands of the leg muscles. The study will also assess whether patients who receive the investigational drug product are able to increase their maximal walking time using a standardizes treadmill walking test. Seventy-five patients will be enrolled into each of 5 study drug groups (3 groups of Ad2/HIF-1a/VP16 gene transfer and 1 placebo group) for a total of 300 patients overall. Three different doses of Ad2/HIF-1a/VP16 gene transfer will be studied. The dose range was previously tested in animals and in the Phase 1 human studies. A placebo group is included in the study to compare safety and efficacy of different doses of Ad2/HIF-1a/VP16 with placebo. Each patient will receive a single set of 20 injections of gene transfer of placebo in one administration to each leg for a total of 40 injections.