ImmuPharma PLC (LON:IMM) Chairman Tim McCarthy caught up with DirectorsTalk to discuss the latest update on their Lupuzor Phase III clinical trial
Q1: Now this morning you’ve put out an update on your Phase III trials of Lupuzor, was Mauritius originally a country selected as part of the Lupuzor trial?
A1: No, it wasn’t and I think that is part of the sort of unexpected nature of this news but positive news that we put out this morning. What we originally intended was that we were going to recruit patients across the US and Europe, and we’re actively doing that and that’s all going very well, but this was specifically a request that was made to us by the Mauritian government, more specifically the President of Mauritius, because it may not be very known but there is quite high incidents of lupus sufferers in Mauritius, when I say high incidents in proportion to their population. The inventor of Lupuzor, a lady called Professor Sylviane Muller who we work with very closely, was invited to go and lecture in Mauritius and discuss with a local lupus patient association there her discoveries of Lupuzor and what we’re doing in clinical studies and during those discussions she was specifically requested by the President of Mauritius whether we, as ImmuPharma, would consider including patients in Mauritius in the current clinical study. So completely unexpected from our perspective but a very welcome intervention by Mauritius for two reasons, one it only sort of helps to accelerate if anything the recruitment rates in the study but also there’s clearly a vast unmet medical need which we knew anyway across the world but when you start to get it down to patient level and you see the real suffering that these patients have we were very keen to include as many people as we can in this wider area and if we can give some hope to those patients in Mauritius then that’s fantastic, really is fantastic.
Q2: I guess that answers my next question, why are you opening, now, a site in Mauritius?
A2: Well because of all the reasons I said, just to clarify we’re not expanding the number of patients in the study, we still have an objective of 200 patients but it just means that with the expectation we could recruit up to 30 patients in Mauritius we just have to recruit that many less either in the US or Europe, that’s why I mentioned if anything it just helps us in our recruitment.
Q3: I guess ImmuPharma must be pretty honoured with the fact that you were requested by the government and Lupus Alert to open up the trial in Mauritius?
A3: We’re very honoured and I think what I would say is this is just another external validation of the work we’re doing with Lupuzor, we’ve had extremely promising data in our earlier clinical studies, both from an ethicacy view i.e. the benefits that it brings to patients but also the completely benign side effect profile such that none of our patients are experiencing any side effects whatsoever. In an area such as Mauritius, which as I mentioned earlier has a very high incidents according to their population, the fact that they are specifically requesting us is fantastic and it is an honour, absolutely it’s an honour that from the highest level of the Mauritian government we’ve been invited to conduct the study in Mauritius. Delighted.
Q4: What are the next key milestones for ImmuPharma PLC?
A4: Well we will continue to update the market on the progress of the study and the next major key milestone will be the complement of the recruitment later this year so that’s the 200 patients. As we look through the end of this year into next year the guidance that we’ve given the market is that the last patient recruited in should be obviously this year, the dosing for each patient is 12 months so if you take the date of the last patient being recruited, add 12 months then that last patient will be completed before 2017 which means the whole of the study is completed then and then we’re looking to put the headline trial results out before the end of 2017. So that’s the guidance we’ve given the market, we’re bang on track so lots of other continued updates on the study between now and the end of 2017.
