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Trophos Initiates Clinical Development for Novel Cardioprotective Compound, TRO40303

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Trophos SA a clinical stage pharmaceutical company developing innovative therapeutics from discovery to clinical validation for indications with under-served needs in neurology and cardiology, announced the initiation of clinical development for TRO40303, a novel mitochondria pore modulator.

TRO40303 could become the first treatment to reduce the cardiac reperfusion injury that contributes significantly to the morbidity and mortality seen post myocardial infarction (MI).

The first-in-human study will enroll healthy volunteers and will compare the safety and tolerability of a single dose of TRO40303 to placebo. The initiation of this study follows promising pre-clinical results, which suggest TRO40303 can significantly reduce infarct size following cardiac ischemia-reperfusion.

“The initiation of the clinical development of our second mitochondrial pore modulator, TRO40303, represents a major advance for Trophos. There are around 1.6 million cardiac reperfusion procedures performed in hospitals and specialist clinics each year in the major markets. This program fits perfectly with Trophos strategy of creating value by targeting niche, high medical need markets,” commented Damian Marron, Trophos’ CEO. “Trophos is excellently positioned to deliver on its goals with this program and with our lead product, olesoxime, in a phase 3 study for the orphan neurological disease of amyotrophic lateral sclerosis as part of the EU funded MitoTarget project.”

The objective of this phase 1 study is to assess the safety, tolerability and pharmacokinetics of single escalating doses of TRO40303 as an intravenous infusion at different rates compared with placebo in 64 healthy volunteers. Results from the study are expected in Q1 2010 and will allow the compound to be moved rapidly into a phase 2 proof-of-concept study in acute MI patients with large myocardial infarct undergoing percutaneous transluminal coronary angioplasty (PTCA also known as coronary or balloon angioplasty) during percutaneous coronary intervention (PCI), where TRO40303 will be dosed as a single iv short infusion immediately prior to the emergency intervention.

“A treatment is urgently required to prevent cardiac reperfusion injury, which is a major problem in the care of MI patients despite the overall improvements in prognosis in recent years,” added Dr Jean-Louis Abitbol, Chief Medical Officer at Trophos. “Cardiac reperfusion injury is a significant unmet medical need with no existing treatment that contributes to long-term morbidity, progression to heart failure and death following a MI. The role of mitochondrial permeability transition in cardiac reperfusion injury has recently been validated clinically making this is a tremendous opportunity for our novel mitochondrial pore modulator, TRO40303, discovered and developed in our laboratories, which targets this mechanism.”