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ImmuPharma update on Lupuzor trial

By BFN News | 07:48 AM | Wednesday 04 November, 2015

ImmuPharma says a number of important operational and regulatory milestones have now been reached in order to allow the recruitment of the first patients into the phase III clinical trial of Lupuzor this year. It says recruitment is anticipated to occur in up to 45 investigator sites - 10 sites in United States and 35 in Europe - to ensure the screening of 270 potential patients, in order to recruit the required 200 patients for the trial. In the United States the trial has been approved by a major Central Institutional Review Board (IRB) which will allow several sites to participate through a single IRB. It is expected that the first sites in the US will be fully initiated in late November/early December and will commence recruiting patients thereafter. In Europe the study is progressing through the centralised Voluntary Harmonisation Procedure (VHP). The VHP application was submitted on 28 October 2015 and this has up to a 60 day review window. The applications to local Ethics Committees will happen in parallel as well as the applications to the local EU Member states. The EU VHP sets out that the study will take place in the United Kingdom, Germany, France, Italy, Czech Republic, Hungary and Poland. In Europe it is expected that the first sites will become fully initiated in January and will then commence patient recruitment thereafter. As an integral part of the study the 'Investigator Meeting' which will include around 100 investigators and senior coordinators from the USA and Europe, will be held in Paris on 11-12th December 2015. The meeting will be introduced by Mr Alain Fuchs, Pr�©sident of the Centre National de la Recherche Scientifique (CNRS), ImmuPharma's scientific collaboration partner. Story provided by

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