FIBREX Medical has successfully completed a first dose in man study with its lead product, the anti-inflammatory peptide FX06. FX06 is developed to prevent reperfusion injury, an undesired inflammatory reaction after acute myocardial infarction. The now completed clinical trial measured tolerability and pharmacokinetics of FX06 in healthy volunteers. The study confirmed the excellent safety profile of FX06 that has already been seen in experimental animal studies.
The clinical trial was performed at the medical University of Vienna, Austria. In total, 30 healthy participants received different doses of FX06 or a placebo, respectively. The trial’s results confirmed that even in high doses FX06 was very well tolerated with no adverse effects observed.
On the successful completion of this study Rainer Henning, CEO of FIBREX Medical, comments: “These very satisfying results allow us to progress rapidly with our development program for FX06. Already last year, in March 2005, we were able to demonstrate FX06’s efficacy in preventing reperfusion in multiple animal models of several species with a highly acclaimed paper in Nature Medicine. Now, just a year later we have finished the phase I trial and are ready to move on to the clinical trial phase II. The preparation for this proof of concept study in patients with acute myocardial infarction is well advanced. In fact, we will enroll the first patient in the second quarter of 2006”. This phase II clinical trial, labeled the FIRE study, will prove FX06’s suitability for treating myocardial infarction in 140 patients in 20 centers in seven European countries. First results will become available in May 2007.
The rapid progress of FIBREX’s drug development program has also been made possible by the successful completion of a series A financing round in March 2005. Leading venture capitalists co-led by Atlas Venture and Global Life Science Ventures invested 10 million US-Dollar to this aim.
Myocardial infarction is caused by occlusion of one or more coronary vessels. Standard treatment aims to restore blood flow as quickly as possible in order to minimize damage to the heart. Although reperfusion is the prerequisite for tissue salvage, it induces an acute inflammatory response that in fact causes damage to the heart muscle. FX06 prevents this harmful inflammatory reaction called reperfusion injury (Recent publication: Nat. Med. Vol.11:298-304; 2005).
In the USA, Europe and Japan each year more than 7,500,000 cardiac revascularization procedures are performed. Frequently, clinical success is hampered by complications. Reperfusion injury ranks prominent among those complications. An effective drug for mitigation of reperfusion injury is viewed by many as the next breakthrough in cardiovascular medicine.
Vienna, 6th April 2006
Dr. Rainer Henning
President & CEO
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