This is a Phase I/II clinical trial. The objective of this study is to evaluate the safety and anti-ischemic effects of adenovirus mediated hFGF-4 gene transfer in patients with stable exertional angina (Class II and Class III) so that a potentially safe and effective dose may be selected for a subsequent study. This is a double-blind, ascending dose, placebo controlled study. Each dose group consists of at least nine active and three placebo patients. The lowest dose (3.2 x 10"9 viral particles) will be studied first. For each dose group, safety observations during the first two weeks are reviewed and safety confirmed for the first patient randomized to active medication before dosing the second patient randomized to active medication. Safety observations for two weeks after the second patient are reviewed and safety confirmed before dosing the remaining patients in each dose group. Sponsor unblinding for all patients is allowed, but the patient, investigator, and his staff all remain blinded throughout the study. Core laboratories read, in a blinded fashion, exercise ECGs, stress echocardiograms, and coronary angiography.
NIH ExPorter
NIH ExPorter