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Ampligen in Phase 2 Clinical Study for the Treatment of Post-COVID Conditions

Discussion in 'Long Covid research' started by Sly Saint, May 3, 2020.

  1. Sly Saint

    Sly Saint Senior Member (Voting Rights)

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    Several posts have been moved from this thread:
    Ampligen - Hemispherx Biopharma re ME/CFS

    not relating to ME but Covid-19
    AIM ImmunoTech inks deal to research vaping device as a vehicle for Ampligen to treat coronavirus
    https://www.proactiveinvestors.com/...for-ampligen-to-treat-coronavirus-916966.html
     
    Last edited by a moderator: Oct 25, 2022
    ukxmrv, Ash, sebaaa and 5 others like this.
  2. Sly Saint

    Sly Saint Senior Member (Voting Rights)

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    AIM ImmunoTech Files Provisional Patent Application for the Use of Ampligen(R) as a Potential Therapy for COVID-19 Induced Chronic Fatigue

    https://www.morningstar.com/news/ac...-therapy-for-covid-19-induced-chronic-fatigue
     
    MEMarge and Kitty like this.
  3. John Mac

    John Mac Senior Member (Voting Rights)

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    AIM ImmunoTech Announces IRB Approval to Enroll COVID-19 ‘Long Haulers’ in the AMP-511 ME/CFS Clinical Trial of Ampligen COVID-19 Patients May Continue to Experience Chronic Fatigue-Like Symptoms

    https://www.biospace.com/article/re...-to-experience-chronic-fatigue-like-symptoms/
     
    Last edited: Oct 13, 2020
    MEMarge, Sly Saint, Michelle and 5 others like this.
  4. Sly Saint

    Sly Saint Senior Member (Voting Rights)

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    AIM Trial Moves Ahead, And Other News: The Good, Bad And Ugly Of Biopharma
    https://seekingalpha.com/article/43...ahead-and-news-good-bad-and-ugly-of-biopharma
     
  5. RedFox

    RedFox Senior Member (Voting Rights)

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    Merged thread

    AIM ImmunoTech Announces FDA Clearance of IND Application to Evaluate Ampligen in Phase 2 Clinical Study for the Treatment of Post-COVID Conditions


    AIM Immunotech will be doing a Phase 2 trial of Ampligen for long Covid fatigue. Here is a press release from the company:

    AIM ImmunoTech Announces FDA Clearance of IND Application to Evaluate Ampligen in Phase 2 Clinical Study for the Treatment of Post-COVID Conditions

    Key quotes:
     
    Last edited by a moderator: Oct 25, 2022
    Mij and Trish like this.
  6. RedFox

    RedFox Senior Member (Voting Rights)

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    Solve ME has also covered this:

    Breaking News: FDA clears Ampligen to start a clinical trial in Long Covid

     
    FMMM1 and Trish like this.
  7. FMMM1

    FMMM1 Senior Member (Voting Rights)

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    Haven't looked at link etc. yet.

    Interesting to see what folks think of this development.

    I think this may be interesting as pre-Covid some of the people on the trial would have been received an ME/CFS diagnosis - correct?
    If the trial is detailed then a small number of people improving, i.e. who would (pre-Covid) have been diagnosed with "ME/CFS", would be of interest to the ME/CFS community.

    Thoughts?
     
    RedFox likes this.
  8. BrightCandle

    BrightCandle Senior Member (Voting Rights)

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    It wasn't well tolerated in ME/CFS patients a lot of people had side effects. The biggest problem is the trial length of 12 weeks and potentially dosage. One of the problems is the effect waned over a few months and no amount of jostling the drug dose seemed to help. Ignoring that problem already exposed in me patients IMO is a fatal flaw of the study design and while it might show efficacy it will hide that it also stops working.

    Just in general I think we need to see 6 and 12 month followups on all long haul and me/cfs drug trials due to the way the disease seems to get better then worse again.
     
    Last edited: Oct 13, 2022
  9. RedFox

    RedFox Senior Member (Voting Rights)

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    I always heard Ampligen had a pretty benign safety profile. I think this is a positive development. If it gets approved for LC it will see immediate, widespread off-label use in ME, but that doesn't mean it will work.
     
    FMMM1 likes this.
  10. CRG

    CRG Senior Member (Voting Rights)

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    After almost 50 years rintatolimod is still a cure in search of a disease.
     
  11. Dolphin

    Dolphin Senior Member (Voting Rights)

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    I haven’t read this properly but it might be of interest to those who follow the topic.

    Source: Globe NewsWire
    Date: October 13, 2022
    URL:
    https://www.globenewswire.com/news-...misses-AIM-s-Baseless-Section-13-d-Claim.html


    U.S. District Court dismisses AIM's 'baseless' Section 13(d) claim
    ------------------------------------------------------------------
    * Court Rules that Allowing Claim to Proceed Would be Inconsistent with
    Statutory Purpose of Investor Protection
    * AIM's Stock Price Continues Dramatic Decline, Closing at New 52-Week
    Low of $0.479 on October 12, 2022, Down More Than 35% Since July 18,
    2022 When AIM Filed the Now Dismissed Lawsuit Against ASFV Committee
    * Worried AIM Board Selectively Discloses Incomplete Information
    Regarding Pending Delaware Action in Attempt to Distract from Failures
     
    RedFox likes this.
  12. RedFox

    RedFox Senior Member (Voting Rights)

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    That sounds like fairly typical investing stuff. Often when a small publicly traded company performs poorly, there will be big fights between "activist" shareholders (those who want to play an active role in how the company is run) and company leadership.

    Edit: Cort Johnson covers this in more detail. In reality, it looks like there were a lot of legal battles because their earlier leadership was incompetent.
     
    Last edited: Oct 16, 2022
  13. CRG

    CRG Senior Member (Voting Rights)

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    So it would seem. A partial list:

    https://bergermontague.com/cases/hemispherx-biopharma-inc-securities-litigation/
    https://casetext.com/case/hemispherx-biopharma-v-bioclones
    https://www.lawyersandsettlements.com/lawsuit/hemispherx-biopharma-inc-heb-securities-2.html
    https://www.bigclassaction.com/lawsuit/hemispherx-biopharma-inc-heb-securities.php
    https://caselaw.findlaw.com/us-11th-circuit/1055767.html
    https://www.biospace.com/article/re...ils-in-multi-million-dollar-federal-lawsuit-/
    https://www.paed.uscourts.gov/documents/opinions/99D0197P.pdf

    https://en.wikipedia.org/wiki/AIM_ImmunoTech

    One take from the investor side might be "this is a company with a bag of magic beans to sell, so what has been the medium term return on magic beans ?" Also "what's the tax break on magic bean R&D ?"
     
  14. RedFox

    RedFox Senior Member (Voting Rights)

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    Cort Johnson covers the trial, along with a history of Ampligen and AIM ImmunoTech, in Health Rising:
    Longtime ME/CFS Drug Ampligen Gets Its Shot with Long COVID
     
  15. Sly Saint

    Sly Saint Senior Member (Voting Rights)

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    RedFox likes this.
  16. RedFox

    RedFox Senior Member (Voting Rights)

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    Provides more detail that what was announced in the media. A few things stick out. The study will only run for 12 weeks or ~3 mo. The main outcome measure is the Promis Fatigue scale. I haven't found a full version online, but a short version is available. Patients must meet the Fukuda criteria, so this is more like a study on chronic fatigue than ME/CFS by the modern definition. Completion expected January 2024.

    While the applicability of this study to ME is limited, I predict that if Ampligen is approved for long Covid, we will see immediate, widespread off-label use for ME, for better or worse.
     
  17. RedFox

    RedFox Senior Member (Voting Rights)

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    AIM ImmunoTech Announces Central IRB Approval of Phase 2 Study Protocol Evaluating Ampligen® for the Treatment of Post-COVID Conditions
    https://www.tmcnet.com/usubmit/2023/04/04/9788662.htm
    They've gotten approval from the group that reviews studies' ethics. The estimated start date on clinicialtrials.gov is March, so hopefully, they're starting very soon. Completion is expected next January.
     
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  18. Dolphin

    Dolphin Senior Member (Voting Rights)

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    Good to see that they are not messing around with open-label trials as they have sometimes done in the past. This looks more useful e.g.

     
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  19. Jaybee00

    Jaybee00 Senior Member (Voting Rights)

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  20. RedFox

    RedFox Senior Member (Voting Rights)

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    AIM ImmunoTech Enrolls and Doses First Subject in Phase 2 Study Evaluating Ampligen® for the Treatment of Post-COVID Conditions
    https://aimimmuno.com/aim-immunotec...n-for-the-treatment-of-post-covid-conditions/

    They're off and running now!
     
    Trish and Dolphin like this.

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