First clinical study of FX06 treatment against damage caused by heart attacks

The green light has been given for the first clinical study of a treatment against damage caused by heart attacks.

Central to the study is FXO6, a peptide developed and patented by Austro-American company Fibrex Medical. Fibrex will now test the tolerability and pharmacokinetics of FX06 in humans. The peptide reduces inflammatory responses of the heart muscle that can arise after treatment for a myocardial infarction. Tests will begin immediately on the first - healthy - subjects at the Vienna General Hospital.

Reperfusion injuries are injuries to the heart muscle arising from treatment of a heart attack. During an infarction part of the heart muscle is cut off from the blood circulation, and acute treatment aims to restore the blood flow to this area as fast as possible. This can often be achieved quickly through invasive surgical procedures, but there is a price to pay. Oxygen radicals form and provoke an inflammatory response in the heart muscle. In a worst case scenario this can even cause irreversible damage.

Fibrex Medical has developed FX06, a fibrin derived peptide that can prevent reperfusion injury to the heart muscle. Following this year’s publication of information on the efficacy of FX06 in Nature Medicine (Vol. 11, pp. 298–304), the trial marks a further breakthrough for Fibrex. CEO Rainer Henning, PhD commented: “A trial of FX06 in selected subjects at the Clinical Pharmacology Unit at Vienna General Hospital is to begin immediately. It will be supervised by Prof. Michael Wolzt and monitored by the Swiss company, Cross S.A. The first step will be to assess the tolerability and pharmacokinetics of the peptide in the human body. The fact that approval of this initial clinical study has been given so quickly and easily has a lot to do with our impressive data demonstrating the efficacy of FX06 in multiple animal models in several species.”

Dr. Henning is already making plans for the summer of 2006, when the efficacy of FX06 in humans will be tested in the next stage of the clinical phase. This strong momentum is due in part to the availability of ample financing. In March 2005, leading venture capitalists put up more than USD 10 million to fund the development of FX06.

This investment decision by the biotech experts at Atlas Venture, EMBL Ventures, Global Life Sciences Venture and Mulligan BioCapital AG reflects the fact that finding an effective drug for mitigation of reperfusion injuries is widely viewed at one of the next big things in cardiovascular medicine. More than 7.5 million revascularization procedures are carried out annually in the US, Europe and Japan alone. These are not always complication free, and for instance, 10% of the cost of bypass operations goes on treating complications such as reperfusion injuries.