NeuTec completes Mycograb recruitment
NeuTec Pharma, the Manchester, UK, biopharmaceutical company targeting drug-resistant, life-threatening infections, has completed recruitment for its double-blind placebo-controlled phase II clinical trial assessing the safety and efficacy of its lead product, Mycograb.
NeuTec Pharma, the Manchester, UK, biopharmaceutical company targeting drug-resistant, life-threatening infections, has completed recruitment for its double-blind placebo-controlled phase II clinical trial assessing the safety and efficacy of its lead product, Mycograb.
The study involved 160 patients at 38 centres in 10 European countries and 3 sites in the US. Trial results are anticipated in Q3 2004, following a three month follow up on each patient.
Recent discussions with the European Medicines Evaluation Agency ("EMEA"), indicated that the trial results, if satisfactory, may be used to support an application for market authorisation for the following clinical indication - 'Mycograb in combination with amphotericin B for the treatment of invasive candidiasis in immunocompetent intensive care patients.'
Mycograb, which was granted Orphan Drug Status in Europe and the US, is based on a naturally-occurring human antibody response against Hsp90, which helps the body defend itself against life threatening fungal infections. Invasive candidiasis is the leading cause of death due to fungal sepsis, with a 40% mortality rate. Around 320,000 cases of systemic fungal infections are reported globally each year.
Professor James Burnie, CEO of NeuTec Pharma, said: 'This is a further milestone for NeuTec Pharma and continues the successful development of Mycograb in the treatment of life threatening fungal infections.'