News:F.I.R.E. Study Misses Primary Endpoint

September 2, 2008 by Scott P Williams [mailto:swilliams@perfuse.org]

The F.I.R.E. Study was an exploratory “proof of concept” trial testing the ability of FX06 to reduce reperfusion injury. 234 patients with ST elevation myocardial infarction were enrolled at 26 interventional cardiology centers throughout Europe. Patients were randomized in a double-blind manner to receive either FX06 (n=114) or placebo (n=120). Patients received a 400 mg of FX06 intravenously at two timepoints: at the start of the percutaneous coronary intervention (PCI) and 10 minutes into the PCI procedure. Patient follow up was conducted at 5 days and 4 months.

The trial’s primary outcome measure was infarct size as measured by cardiac magnetic resonance imaging (CMR) at 5 days. Patients treated with FX06 had a median delayed enhancement zone of 21.68 g, while patients receiving placebo had a median of 27.34 g. This 21% reduction in infarct size failed to reach statistical significance (p=0.207). There was a statistically significant 58% reduction in the necrotic core zone of the infract area demonstrated among patient that received FX06 (1.77 g) compared to patients that received placebo (4.20 g) (p=0.019).

There were no statistically significant differences achieved by FX06 in the study’s secondary endpoints of scar mass and infarct size at 4 months. Median total enhancement zone was reduced by 20% in the FX06 population when compared to placebo (15.37 g vs. 19.32 g; p=0.363). The median scar mass was 1.79 g in patients that received FX06 versus 2.84 g in patients that received placebo, a 37% reduction (p=0.159).

Similarly, trends in favor of FX06 were observed in the trial’s secondary endpoints of LV function at 5 days and 4 months post-procedure and Troponin I, but statistical significance was not achieved for both endpoints.

Major adverse cardiac events (MACE) occurred less frequently in the group that received FX06 (21 events vs. 29 events), which led Dr. Atar to speculate that this “may indicate an effect of the drug on adverse patient outcome after an infarction.

There are currently plans to further explore FX06’s role as a cardioprotective adjunct to PCI and its effect on the size of necrotic infarct zone in a 4000 patient trial.

The F.I.R.E. Study was funded by Fibrex Medical Research & Development GmbH. Dr. Atar received honoraria from Fibrex Medical Research & Development GmbH.