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The AGENT clinical trials programme

C.L Grines*

Division of Cardiology/3rd Floor Heart Center, William Beaumont Hospital, Royal Oak, USA

* C.L. Grines, Division of Cardiology/3rd Floor Heart Center, William Beaumont Hospital, 3601 West 13 Mile Road, Royal Oak, MI 48073-6769, USA. Tel.: +1-248-551-7280; fax: +1-248-551-8806
cgrines{at}beaumonthospitals.com

Abstract

AGENT and AGENT 2 are the first randomized, double-blind, placebo-controlled trials studying the benefits of stimulating coronary angiogenesis with gene therapy. To promote collateral circulation, Ad5FGF-4 was infused into coronary arteries of patients with chronic stable angina.

AGENT evaluated doses of Ad5FGF-4 from 3.3x108 to 3.3x1010 vp in 60 patients who tolerated the therapy well. Exercise time on a treadmill (ETT) improved in patients with baseline ETTs <=10 min, but not in pooled data from all doses. Additionally, 50% of patients given 1x1010 vp had increased ETT, versus 16% in the placebo group ( and 16, respectively, ). Doses of 1010 and 109 vp were chosen for further study.

AGENT 2 determined whether Ad5FGF-4 improved myocardial perfusion compared with placebo. A significant decrease in ischaemic defect size was observed in patients treated with Ad5FGF-4 compared with baseline (, 21% relative decrease, ) that was not found in placebo group (, ). Again, Ad5FGF-4 was well tolerated.

AGENT 3 and 4 trials were planned to determine the efficacy and safety of Ad5FGF-4 in selected doses in larger populations. An interim review of the data from AGENT 3 indicated no safety concerns. However, differences in ETT were unlikely to reach significance. Therefore, further recruitment in the trials was stopped.

Key Words: Myocardial ischaemia • Stable angina • Angiogenesis • Fibroblast growth factor • Adenovirus • Clinical trials


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