Professor Dan Atar, the Coordinating Investigator of the F.I.R.E. (FX06 In ischemia and REperfusion) trial, a Phase II clinical study of FX06, will present the results of the trial at 12-noon on September 2nd in the Hot Line III Session at the European Society of Cardiology Congress in Munich, Germany.
"Re-establishment of blood flow, either by catheter-based balloon-intervention (PCI) or by thrombolysis, is necessary and life-saving in the treatment of acute myocardial infarctions. However, such interventions can lead to further damage to the heart muscle due to blood vessel dysfunction and inflammation," said Dan Atar, Professor of Cardiology at the Aker University Hospital, University of Oslo, Norway. "Based on the F.I.R.E. results, FX06 has been shown to reduce damage to the heart muscle by inhibiting inflammation and protecting vascular function. We predict that FX06 may become a novel treatment for STEMI patients undergoing PCI, representing a major advance in acute cardiac care."
The Phase II clinical trial of FX06 (F.I.R.E. study) was completed in March 2008, with data indicating a statistically significant reduction in myocardial necrosis following intravenous application of FX06 concurrent with reperfusion. FX06 is a peptide that binds to VE-cadherin, a target on the surfaces of endothelial cells, which form the inner cell layer of blood vessels, thereby preserving blood vessel function. This leads to reduced inflammation, reduced oedema and reduced infarct sizes.
About the study:
The F.I.R.E. (FX06 In Ischemia and REperfusion) trial was conducted between October 2006 and March 2008 as a randomized, double-blind, placebo-controlled study involving 234 patients from 26 leading centres of interventional cardiology in Europe. The study evaluated infarct size in patients undergoing percutaneous coronary intervention (PCI) for acute ST-segment elevation myocardial infarction (STEMI). FX06 was administered intravenously to patients during reperfusion treatment, and the effect on heart muscle preservation was then assessed using the most advanced imaging technology: cardiac magnetic resonance imaging (CMR). The primary endpoint was reduction in infarct size at five days after myocardial infarction.
Results showed that at 5 days post-PCI, the necrotic zone of the infarct was significantly reduced by 58% and the total affected zone of the left ventricle was reduced by 21%. This was accompanied by a reduction in markers of heart muscle cell necrosis. After 4 months, the resulting scar mass was reduced by 37%, suggesting that a reduction of reperfusion injury indeed may lead to decrease in scar tissue formation. Major adverse cardiac events in the FX06 group were also lower compared to the placebo group, which may indicate an effect of the drug on adverse patient outcome after an infarction.
Authors:
Professor D Atar
Tel: +49 89 5700 1806 (PR Agency)
E-mail: dan.atar@online.no
Notes to editor
This press release accompanies both a presentation and an ESC press conference given at the ESC Congress 2008. Written by the investigator himself/herself, this press release does not necessarily reflect the opinion of the European Society of Cardiology.