Lupuzor™ Phase III Pivotal Trial Update
4th November 2015 - 5:55 pm
ImmuPharma PLC (LSE:IMM), (“ImmuPharma” or the “Company”), the specialist drug discovery and development company, is pleased to provide an update on the progress of its Phase III clinical trial of Lupuzor™, its lead programme for the potential breakthrough compound for Lupus, the life threatening auto immune disease.
The pivotal Phase III trial is progressing in conjunction with Simbec-Orion, the Company’s contract research organisation conducting the study. A number of important operational and regulatory milestones have now been reached in order to allow the recruitment of the first patients into the study this year, particularly:
- 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, Président of the Centre National de la Recherche Scientifique (CNRS), ImmuPharma’s scientific collaboration partner.
Further updates on the progression of the Lupuzor™ Phase III trial will be announced, as appropriate, as the trial progresses.
Tim McCarthy, Non-Executive Chairman of ImmuPharma said:
“Following my recent appointment as Chairman I have now had the opportunity to review the progress of the Phase III study with both the ImmuPharma development team and Simbec-Orion. I am confident that given the dedication and expertise of the ImmuPharma team combined with the experience of Simbec-Orion, the study will progress as planned with the anticipation of completing the study by the end of 2017.”
Ronald Openshaw, CEO of Simbec-Orion further commented:
“We continue to work closely with the development team at ImmuPharma on the Lupuzor™ Phase III trial. Lupuzor™ has the potential to be a significant treatment for lupus sufferers globally and we are delighted to be contributing to its progress through this last stage of development.”
Robert Zimmer, President and CSO of ImmuPharma added:
“Dr Fanny Valleix, our VP Clinical development at ImmuPharma France is leading the project. She brings her strong expertise gained from her past as project director at an international contract research organisation as well as an independent consultant. The Lupuzor™ project is in good hands.”