France: Bio-Modelling Systems to start phase II clinical trial(s)

Discussion in 'ME/CFS research news' started by cassava7, May 1, 2020.

  1. cassava7

    cassava7 Senior Member (Voting Rights)

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    Recent news apparently, for what it's worth. They are the bioinformatics company that the French association for CFS have partnered with, though we members haven't received any details.

    They have set up a page on their website about ME, where they present their understanding of its pathophysiology (unproven claims): https://www.bmsystems.org/cfs-me
    More info on CADI: "Computer Assisted Deductive Integration"; slides from a 2011 presentation at the European Congress of Psychiatry:

    ETA: they have published a leaflet on post-COVID19 ME.
     
    Last edited: May 1, 2020
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  2. Hutan

    Hutan Moderator Staff Member

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    If this is the starting understanding of CFS/ME, I doubt that Computer Assisted Deductive Integration is going to help much.

    GIGO
     
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  3. Hutan

    Hutan Moderator Staff Member

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    Screen Shot 2020-05-02 at 9.53.13 AM.png
     
  4. Trish

    Trish Moderator Staff Member

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    I had a look at all the stuff linked, but couldn't find anywhere what the treatment being tested actually involves. Lots of fancy diagrams, but no specifics - drugs? nutrients? therapy? I'm bemused. Did I miss something? Is there a protocol for this trial registered anywhere?
     
  5. cassava7

    cassava7 Senior Member (Voting Rights)

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    None -- you didn't miss anything. The association might release a bit more info soon-ish but they're under non-disclosure agreements.
     
    Last edited: May 2, 2020
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  6. cassava7

    cassava7 Senior Member (Voting Rights)

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    They are preparing a phase 2 clinical trial for a combination of already approved medication. No info given as to what this combo might be.

    They haven't done a phase I trial, because they say that the individual meds in this combo are not toxic and so the combo shouldn't be toxic either. So they don't expect health authorities to ask them to do a phase I trial.
     
  7. Invisible Woman

    Invisible Woman Senior Member (Voting Rights)

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    Hmmm.....I don't think that just because drugs might be safe individually it necessarily follows that they'll be safe in combination unless they are very confident in their knowledge of both individual drugs.

    I suppose if they're existing & well known drugs they might have reason to be.

    I guess we'll find out. Eventually.
     
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  8. Trish

    Trish Moderator Staff Member

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    If it's a properly registered clinical trial they will presumably have to publish their list of drugs and dosages beforehand.
     
  9. cassava7

    cassava7 Senior Member (Voting Rights)

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    BMSystems were interviewed in Global Benefits Vision about the risk of post-COVID19 ME/CFS. They provide more information about their upcoming clinical trial and their scientific understanding of the disease,

    About ME/CFS itself

    Their description of ME/CFS (p. 32) does not include PEM, but the Venn diagram figure underneath the description does and ME/CFS is presented as:
    On page 36, they present the context around ME/CFS quite well. They mention important issues such as the different diagnostic criteria, the absence of medical education and of a biomarker, the underdiagnosis of ME/CFS (cites IOM report), and there's also this relieving part:
    Their understanding of the pathophysiology of ME/CFS (pp. 33-35)

    They understand ME/CFS as "an inflammatory disease" caused by "the superposition of humoral and cellular responses" (diagram on p. 35).

    The clinical trial/treatment: CADI-T1031

    A personalized treatment, apparently.
    Two phases: an "immune equilibration" treatment (2-6 months) to resolve immune dysregulation, followed by an "energetic rehabilitation treatment" (6 months - 2 years). A maintenance treatment could be given afterwards.

    They say the combination of drugs used is non toxic and has no side effects.

    Post-COVID19 risk of ME/CFS

    Page 34:
    They cite the post-SARS studies from Lam & Modolfsky (p. 34), Mady Hornig's report for Solve CFS (p. 31), and a number of articles about the risk of post-COVID19 ME from the New Scientist, the Guardian, ME Association, the Telegraph (p. 40)

    [1] Manuel Géa, Dr. Athanasios Beopoulos, Dr. François Iris. "Life after COVID-19: dealing with Chronic Fatigue Syndrome?". Global Benefits Vision, Issue 47 (April 2020). https://www.bmsystems.net/download/...ssue-047-BMSystems-CFS-Post-Covid-19-2020.pdf
     
    Last edited: May 30, 2020
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  10. NelliePledge

    NelliePledge Moderator Staff Member

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    What do they mean by energetic treatment? Are there any specifics?
     
  11. butter.

    butter. Senior Member (Voting Rights)

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    if something sounds to good to be true it is to good to be true ... when will this trial start?
     
  12. Jonathan Edwards

    Jonathan Edwards Senior Member (Voting Rights)

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    This is just babble I am afraid. I can't even be bothered to work out which babble.
     
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  13. Hoopoe

    Hoopoe Senior Member (Voting Rights)

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    Is it not-worth-reading babble?
     
    Last edited: May 30, 2020
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  14. Snow Leopard

    Snow Leopard Senior Member (Voting Rights)

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    Indeed. Seems strange that we can't find any more info about what they are actually doing.
     
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  15. Jonathan Edwards

    Jonathan Edwards Senior Member (Voting Rights)

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    Depends if you need a headache right now.
     
  16. Sam Carter

    Sam Carter Established Member (Voting Rights)

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    @Trish, I think their treatment is one (or more) of a grab-bag of common psychotropic drugs given in conjunction with a "connexin-blocking agent" (usually meclofenamic acid) which is claimed to potentiate the action of the psychotropic drug so that it can be given at a lower dose. [*]

    The patent suggests that the following (somewhat broad) range of conditions may benefit from the drug combination: "psychiatric and/or neurodegenerative disorders included in the group consisting of depression, bipolar disorder, epilepsy, schizophrenia, generalized anxiety, depression, conditions due to stress, panic, phobias, obsessive compulsive disorders, behavioral disorders, immune system depression, fatigue and symptoms associated with pain, chronic fatigue, fibromyalgia, and other disorders such as autism, attention deficit, hyperactivity, eating disorders such as bulimia, anorexia, obesity, psychic disorders such as apathy, migraine, pain, cardiovascular diseases, neurodegenerative disorders and disorders associated with depressive anxiety (Alzheimer's disease, Huntington's disease, Parkinson's disease), drug dependence and drug addiction."

    [*] Use Of Anti-Connexin Agents For Modulating The Therapeutic Effect Of Psychotropic Drugs

    Applicants: Commissariat A L'Energie Atomique Et Aux Energies Alternatives, Paris (FR); Bio Modeling Systems Ou Bmsystems, Paris (FR)

    Inventors: Franck MOUTHON, Paris (FR): Mathieu CHARVERIAT, Issy Les Moulineaux (FR); Jean-Philippe DESLYS, Le Chesnay (FR); Francois IRIS, Chaville (FR)
     
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  17. Dolphin

    Dolphin Senior Member (Voting Rights)

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    Merged thread

    Interview about BMSYSTEMS with Manuel Géa, Dr. Athanasios Beopoulos and Dr. François Iris

    I believe that BM Systems of France are undertaking some ME/CFS research and a national ME/CFS organisation is working with them in some way.

    https://www.global-benefits-vision.com/life-after-covid-19-dealing-with-chronic-fatigue-syndrome/

     
    Last edited by a moderator: Jun 10, 2020
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  18. Hoopoe

    Hoopoe Senior Member (Voting Rights)

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    Contains no details whatsover, but makes some bold claims. Best not to expect anything from this group.
     
    Last edited: Jun 10, 2020
  19. cassava7

    cassava7 Senior Member (Voting Rights)

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    Last edited by a moderator: Jun 10, 2020
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  20. seseb1

    seseb1 New Member

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    I saw the webinar ... I am French, member of the ASFC (French patients association of cfs), you will not have more information than Cassava has to give here because of the restrictions of commercial information that they must respect. This is the only way to find a partnership with a company that can work with BMS for the different stades of AMM. and distribute the medical solution.
    They are very confident about their disease mechanism and the success of their treatment. stages II and III should take place in 2021-2022 for acceptance by French social security in 2023 if efficient. It's the first time until many time that i have hope ...
    they said that they'll published soon about the mechanism. (but my memory isn't enough good to remember more info about this part; when the replay will be available, i'll complete my message)
     
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