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Trophos Announces Final Patient Completion of Phase II Study of TRO40303

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Trophos SA has announced the final patient completion of a phase II study of TR040303 in patients treated for acute myocardial infarction (MI). Outcome data of this study is expected to be available towards the end of 2013.

The Phase II proof-of-concept study has been designed to evaluate the efficacy and safety of Trophos TRO40303, a novel mitochondria pore modulator with broad cytoprotective properties, to treat cardiac ischemia-reperfusion injury (IRI) in acute myocardial infarction (MI) patients.

The clinical study is part of the FP7 collaborative MitoCare project, granted EUR 6 million by the European Commission. The project is led by Trophos and operated by a consortium of 16 European institutions specializing in clinical and basic research, biomarkers, imaging and informatics.

165 patients were enrolled in ten centers in four European countries, (France, Norway, Denmark and Sweden) in a double-blind, randomized, placebo-controlled study. Patients received an intravenous bolus of TRO40303 or matching placebo immediately preceding percutaneous coronary intervention (primary PCI) to treat a first acute STEMI.

The primary endpoint of the study is the reduction of myocardial tissue damage. The level of damage is assessed by measuring cardiac proteins, Troponin I and CK that are released into the circulation.

An additional major endpoint is the measurement of infarct size as a percentage of the at-risk myocardium, expressed by myocardial salvage index. This is assessed by cardiac magnetic resonance imaging (CMR) performed between three and five days after intervention.

"Preventing mitochondrial permeability transition and subsequent tissue damage resulting from reperfusion is a promising approach to the treatment of IRI that should significantly reduce infarct size in STEMI patients," said Dr. Dan Atar MD PhD, professor of cardiology, University of Oslo, Norway and principal investigator for the study.

Dr. Atar continued, "We look forward to sharing the clinical experience of this innovative compound and comparing CMR with plasma biomarkers as predictors of outcome in STEMI patients as soon as the results become available."

"Trophos is very pleased to report completion of the clinical part of the MitoCare study," said Wilfried Hauke MD, chief medical officer at Trophos. "TRO40303 offers a therapeutic option for the treatment of acute myocardial infarction. Further reducing the tissue damage due to reperfusion injury is expected to improve the long-term outcome in these patients."

“There are around 1.6 million cardiac reperfusion procedures performed in hospitals and specialist clinics each year in the western world alone”, said Christine Placet, CEO, Trophos. “This MitoCare program fits perfectly with Trophos strategy and pipeline of creating value by targeting niche, high unmet medical need markets.”

Cardiovascular diseases, among them acute MI, are the leading causes of death in the world. Despite the overall improvements in the care of MI patients with efforts made to initiate PCI as early as possible, treatments that further reduce tissue damage due to reperfusion injury are needed to maximize survival of heart tissue and improve patients prognosis in terms of long-term morbidity, progression to heart failure and death following an MI.