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TAMARIS: NV1FGF gene therapy failed to prevent amputation, death in patients with PAD

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American Heart Association Scientific Sessions 2010

CHICAGO — NV1FGF gene therapy, a therapy still considered experimental in the US, produced numerically worse rates of amputation and mortality in patients with peripheral arterial disease compared with placebo, according to recently presented data.

The NV1FGF Gene Therapy Trial on Amputation-Free Survival in Critical Limb Ischemia (TAMARIS) was a phase 3, randomized, double-blind, placebo-controlled trial featuring 525 patients. The patients (70% men; mean age, 70 years) were at high risk of losing a leg due to PAD and were randomly assigned to either receive NV1FGF gene therapy (n=266) or placebo (n=259). Researchers performed injections in the leg muscle on days one, 15, 29 and 43 of the study.

The primary endpoint of time to major amputation or death favored the placebo arm with an RR of 1.11 (95% CI, 0.83—1.49) in the gene therapy group. Overall, the amputation rate among patients given placebo was 21% vs. 26% in those treated with gene therapy, while the mortality rate among those taking placebo were 15% vs. 18% in the NV1FGF arm, with neither result attaining statistical significance.

“This was a definitively negative trial,” said study author William R. Hiatt, MD, professor of medicine at the University of Colorado Denver School of Medicine, researcher in a press conference. “One question might be why was the phase 2 [trial] positive and the phase 3 [trial] negative? I would simply say that this underscores the need to do properly conducted phase 3 trials and that you shouldn’t make therapeutic decisions based on phase 2 trials.”

For more information:

• Hiatt W. LBCT III, Abstract 1790. Presented at: American Heart Associaiton Scientific Sessions 2010; Nov. 13-17; Chicago.

I would like to congratulate the investigators of the study. I can say from personal experience that conducting trials with patients with critical limb ischemia is one of the toughest ventures for an academic investigator to undertake. The patients are extremely sick and the event rates are very high.

This is indeed a global disease. In the US every year, 100,000 amputations are undertaken for patients with this condition. Multiplying them by the world population you can see that remains a large public health threat and therefore I certainly hope that investigations will continue into this realm.

– Douglas Losordo, MD
Cardiology Today Editorial Board

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