Fibrex Reports Positive Results From Phase II Reperfusion Injury Trial
Fibrex Medical, a biopharmaceutical company focusing on cardiovascular and inflammatory diseases, has announced positive Phase II results for FX06, a peptide for the treatment of reperfusion injury – the damage to heart muscle that results from remedial treatment following a heart attack.
The Phase II clinical trial of FX06 (Fire 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 intravenous application of FX06 during reperfusion treatment.
FX06 is said to be a peptide that binds to vascular endothelial cadherin, thereby inhibiting tissue inflammation and injury as well as preserving endothelial barrier function. These effects are deemed to be important for the prevention of the paradoxical additional damage to the heart muscle known as reperfusion injury.
Fibrex is now planning an ambitious development program to bring this 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 in later 2008.
Rainer Henning, president and CEO of Fibrex Medical, said: “FX06 is a first in class product and we have demonstrated that it can provide clinical benefit by preventing reperfusion injury for the huge number of patients who survive heart attacks each year. FX06 can clearly be expected to become an important addition to the armamentarium of the cardiologist in the catheter lab.”