Tuesday, 9 May 2017

#NewsSpeak: MS-STAT2 finally takes-off

Finally a phase 3 trial in progressive MS is being done outside of Big Pharma. #NewsSpeak #MSBlog


MS-STAT2 takes-off

Great news for people with progressive MS. We will now get an answer about whether or not simvastatin works in a larger study, its safety profile and more importantly its risk:benefit profile in people with more advanced MS. This study may give us clues about how simvastatin is working; is it working via comorbidities or specific anti-inflammatory or neuroprotective mechanisms? 

Have we learnt our lessons about drug repurposing? If positive will this trial lead to a regulatory submission and label extension for simvastatin? Who will manage the regulatory submission? Who will maintain the license? Will one phase 3 trial be sufficient? Will the regulators want more data on a dose-response? Will a regulatory submission be necessary? If simvastatin goes unlicensed for MS will the wider community adopt it? How will it be used in clinical practice; as a monotherapy or add-on to all other DMTs? How will Pharma respond? All these questions will only need to be answered if the trial is positive; so let's find out. 

Congratulations to Jeremy Chataway and the team who pulled this together. Getting trials like this designed, costed and funded is no easy task, particularly when you see the number of partners. Well done! Pharma must be asking how academia can run trials of this size and complexity so cheaply. May be the Pharma machine has become too complex? 





CoI: Barts-MS are a partner organisation in the MS-STAT2 trial

17 comments:

  1. Would the drug be made available to "PPMSers"?

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    Replies
    1. If done via regulators I would think no but if done off label why not.

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  2. What is the mechanism thought to be ?

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    Replies
    1. Good question Adam. Have you seen the answer anywhere in the media reports.Ypu would think it would be somewhere.

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    2. Anon 3.42 really?
      The influences of stations are known and they are not without influence.

      Delete
  3. I wonder if over the counter cholesterol lowering supplements work in a similar way? Such as Beta-sitosterol. Not that I'm suggesting buying them.

    ReplyDelete
  4. Maybe Team G likes this,

    It appears that Simvastatin inhibits HMG CoA reductase (statins) in treating Epstein-Barr virus-induced lymphoma, as well as appears to have an Antimicrobrian / antiviral and immunomodulatory action ...

    Https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2362042/


    Https://www.ncbi.nlm.nih.gov/pmc/articles/PMC387356/


    Https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=8&cad=rja&uact=8&ved=0ahUKEwis2brHiuPTAhXIVyYKHXC1A24QFghIMAc&url=http%3A%2F%2Fcid.oxfordjournals.org%2Fcontent%2F48% 2F6% 2F745.full.pdf & usg = AFQjCNE36U8qyBRzZR3indUDG_rxYO9FhA & sig2 = VFk52Wr93KfoGOCQ1VJ3mg

    ReplyDelete
    Replies
    1. As an anti proliferative agent anything could be anti viral.
      Not sure it was a really that anti viral....profG what do you think?

      Delete
  5. Does 'Great news for people with progressive MS' cover ppms, or solely secondary progressive ?

    Regards as always.

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    Replies
    1. I am afraid secondary progressive ms. PPMS now has a treatment in USA and that is ocrelizumab. The regulators should not entertain a single trial fot PPMS unless they have different rules for pharma and academia.

      They may have but if they do is that the end of the regulators

      Delete
  6. Will MS-stat2 trial be compared to placebo or another existing medication?

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  7. Why not use simvastatin for RRMS too?

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    Replies
    1. Indeed. It has been used in numerous trials and the results were not clear cut. As a DMT the current treatments are better. The neuroprotective effect has yet to be properly shown


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  8. This is good news for folks with SPMS. Now the awkward questions. Is acceptance on the trial going to be based solely on EDSS and age, ie EDSS LT/EQ 6.0 and younger than 60? This would be a wonderful opportunity to implement some of the ThinkHand ideas.

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    Replies
    1. I agree and wonder whether ProfG had any input on the tiral design but I bet it is a replication of the phase II. But simple answer is I dount know.

      Delete

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