�Fibrex Medical, a biopharmaceutical company focalisation on cardiovascular and incitive diseases, proclaimed positive Phase II results for FX06, a peptide for the treatment of reperfusion injury - the damage to heart musculus that results from remedial treatment following a marrow attack. The results testament be presented at the ESC Congress today in Munich, Germany.
The Phase II clinical trial of FX06 (F.I.R.E. study) in 234 patients with acute myocardial infarcts was completed in March 2008, with data indicating a statistically significant reduction in myocardial necrosis compared to placebo following endovenous application of FX06 during reperfusion discussion . FX06 is a peptide that binds to vascular endothelial (VE) cadherin, thereby inhibiting tissue inflammation and injury as well as preserving endothelial barrier function. These personal effects are deemed to be important for the bar of the paradoxical additional damage to the heart muscle known as reperfusion injury.
"We are entranced that FX06 has demonstrated efficacy in this Phase II tryout" stated Dr. Rainer Henning, President and CEO of Fibrex Medical. "FX06 is a first base in year product and we have demonstrated that it can provide clinical benefit by preventing reperfusion injury for the brobdingnagian number of patients world Health Organization survive heart attacks each year. FX06 can clearly be expected to become an significant addition to the armamentarium of the cardiologist in the catheter lab."
"Re-establishment of roue 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 tissue damage due to resulting rid radicals and an intense inflammatory answer," said Dan Atar, Professor of Cardiology at the Aker University Hospital, University of Oslo, Norway, wHO is the Coordinating Investigator for the F.I.R.E. Study. "Based on the F.I.R.E. results, we believe that FX06 lavatory inhibit this inflammatory response and thus prevent reperfusion injury in patients. We predict that FX06 may become a novel treatment for STEMI patients undergoing PCI representing a major advance in acute cardiac care."
Fibrex is at present planning an ambitious development program to bring this promising new product to registration and expect to carry this program out together with a licensing partner. This program will be discussed with regulatory agencies in US and Europe subsequently this year.
About Fibrex Medical Inc.
Fibrex Medical Inc. is a in camera held troupe headquartered in Cambridge, MA, USA with operations in Vienna, Austria. The Company is developing innovative therapeutics for incisive and intensive care in cardiovascular and inflammatory conditions based on novel mechanisms of action. Fibrex Medical started trading operations in 2001, and has raised a �13 M in investments from top tier venture capital investors including Atlas Venture, Global Life Science Ventures, EMBL Ventures and Mulligan Biocapital. http://www.fibrexmedical.com
Acute Myocardial Infarction (AMI) and reperfusion injury
Acute Myocardial Infarction (AMI) clay to be the number one grounds of last in the developed reality with roughly 2.1 million young cases per year in the USA, Western Europe and Japan. Percutaneous coronary thrombosis intervention to re-establish blood flow has become the standard of care for AMI patients. While rapid reperfusion is essential to preserve myocardium, the sudden exposure of the ischemic area to blood leads to an acute rabble-rousing reaction causation additional damage. It is now well accepted that this process termed reperfusion injury limits clinical success of the intervention.
About the Phase II (F.I.R.E.) study (FX06 in Ischemia / REperfusion)
The Phase II clinical trial of FX06 (F.I.R.E. study) randomized 234 patients with acute myocardial infarcts, to FX06 or placebo, with data indicating a statistically significant reduction in myocardial gangrene following intravenous application of 400mg FX06 at the time of reperfusion. Detailed results will be presented at the ESC Congress on second September in Munich, Germany.
Magnetic resonance imaging data showed that at 5 days subsequently the treatment the necrotic zone of the infarction was significantly reduced by 58% with FX06 and the summate zone of the left ventricle moved by the ischemia was reduced by 21% (non statistically substantial). This was accompanied by a decrease of markers of muscle damage (troponin I and CK-MB). After 4 months the resulting scar was also reduced to some extent, suggesting that a reduction of reperfusion injury leads to decrease in scar formation. There were signs of clinical efficaciousness as well, since cardiac related good events were also lour in FX06 treated patients (21 vc. 29 events).
Fibrex Medical Inc.
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