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 trials 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 FX06s 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 FX06s suitability for treating myocardial infarction in 140 patients in 20 centers in seven European countries. First results will become available in May 2007.
Till C. Jelitto | alfa
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