NeuTec commences PIII MRSA trial
Manchester, UK-based NeuTec Pharma's Aurograb, which targets MRSA, the hospital 'superbug', has commenced a double-blind placebo-controlled phase III clinical trial.
Manchester, UK-based NeuTec Pharma's Aurograb, which targets MRSA, the hospital 'superbug', has commenced a double-blind placebo-controlled phase III clinical trial.
Eight centres are active in three countries and the first patients have now been recruited. The study will be carried out in a total of 35 centres in six European countries and will involve the recruitment of approximately 250 adult hospitalised patients with deep-seated staphylococcal infections. The trial will compare the effects of Aurograb in combination with vancomycin versus vancomycin alone in the treatment of MRSA infection.
This latest trial follows an earlier phase IIb study which was completed in June 2003 and found the drug to be well tolerated and demonstrated a profile that supports likely activity against MRSA in man.
Aurograb has activity on its own against strains of MRSA, but when combined with vancomycin, the current 'gold standard' treatment, is more effective than either drug used on its own. This activity is also evident in strains with partial resistance to vancomycin or linezolid. A recent American publication reports that fully resistant strains to vancomycin have been identified in the US.
Professor James Burnie, chief executive of NeuTec, said: 'MRSA is an increasingly prevalent life threatening disease which is currently poorly understood by the medical community. We are keen to advance our clinical trials in this area and are pleased to have commenced our Aurograb phase III trials.'