Munich, Germany, 2 September 2008- Data presented today at the European Society of Cardiology Congress demonstrates the effectiveness of a peptide called FX06 in preventing cardiac damage resulting from treatment following a heart attack. While reperfusion is well established as a standard of care, it paradoxically causes additional damage to heart muscle in patients surviving from these attacks - a phenomenon termed “reperfusion injury”. FX06 is a novel compound intended to prevent that damage.
“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 targets the surfaces of endothelial cells (which invest blood vessels) thereby interfering with blood vessel function. This leads to reduced inflammation, reduced edema 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%. After 4 months, the resulting scar mass was also reduced by 37%, suggesting that a reduction of reperfusion injury indeed leads to decrease in scar tissue formation. Four patients experienced major adverse cardiac events in the FX06 group versus sixteen in the placebo group, a significant difference. Cardiac related serious events were also lower in FX06 treated patients.
Dr. Rainer Henning Tel. 01/ 59999-170 Mobil: 0664/ 415 95 11 E-Mail: rainer.henning(at)fibrexmedical.com