#ClinicSpeak & #: Charcot Project Update

Where to next for the Charcot Project? #ClinicSpeak #MSBlog #CharcotProject

We keep getting asked, and criticised, about the Charcot Project (CP). Some of you want to help fund the next phase, others feel let down because we haven't started and completed the next phase already and others want to know the results of the two studies we have done under the CP umbrella. In short the CP is alive and kicking and apologies we haven't posted more on the CP.  I have no excuse, except to say there are only so many hours in my day and I take the blame. As I have said before I am the bottleneck in the system. 

Results

  1. We presented the INSPIRE trial results at ECTRIMS (see posters below) and have already presented them on the blog. In summary, the Raltegravir (Isentress) Pilot Study in Relapsing Multiple Sclerosis (INSPIRE) (NCT01767701), was negative. We did not show an impact of raltegravir on inflammatory disease activity in MS as measured by Gd-enhancing MRI. In the biomarker component of the study there was a weak association between EBV shedding and the total number of lesions, probably driven by new lesion development. This may indicate that EBV shedding is associated with inflammatory disease activity in MS. We plan to explore this further with a larger study (see below). The weak correlations between HERV-W markers, EBV shedding and new MRI lesions were independent of any raltegravir treatment effects.
  2. We have also presented the Crowdacure EBV salivary shedding study on the blog. The study has allowed us to do power calculations for our next study (see previous post). The follow-on study will now look at the impact of Famciclovir, a potential anti-EBV drug, on salivary shedding. This study will simply ask the question of whether, or not, FamV has an impact on lytic EBV infection in pwMS. At your request we will also be doing this study using the Crowdacureplatform.   
Publications

In the next 4-6 weeks we will be submitting 3 publications

  1. The primary outcome results of the INSPIRE study.
  2. The biomarker results of the INSPIRE study.
  3. The Crowdacure EBV salivary shedding study.
Grant applications
  1. We will be costing and submitting the follow-on Crowdacure study. This will happen over the next 2-3 months. This is a slow process as Crowdacure has a robust peer-review process. Peer-review is the best way of making sure the science is robust and is going to answer the correct question. With Crowdacure it is not only about getting through the peer-review process, but we also have to convince the reviewer's that our project is hard to fund medical research. This is what Crowdacure does. I suspect the showing that our project has been hard to fund won't be too difficult as this builds on our previous project.
  2. In parallel we will be exploring a link between EBV salivary shedding and MS disease activity. The grant will be submitted to the UK MS Society.
  3. Another potential line of research is looking at the impact of Teriflunomide on EBV biology. We have only recently become aware that Teriflunomide is an antiviral drug. We anticipate Teriflunomide being our third drug under the TCP umbrella. 

The black swan is always in our minds!




CoI: multiple

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