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HEMISPHERX EXPANDS AMPLIGEN EARLY ACCESS PROGRAMME TO CANADA TO TREAT ME/CFS PATIENTS

Discussion in 'Antivirals, Antibiotics and Immune Modulators' started by John Mac, Apr 4, 2018.

  1. John Mac

    John Mac Established Member (Voting Rights)

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    April 4 (Reuters) - Hemispherx Biopharma Inc:

    * HEMISPHERX EXPANDS AMPLIGEN EARLY ACCESS PROGRAMME TO CANADA TO TREAT ME/CFS PATIENTS

    * ‍AMENDED TO INCLUDE MANAGEMENT OF A SAP IN CANADA FOR PATIENTS SUFFERING FROM MYALGIC ENCEPHALOMYELITIS/CHRONIC FATIGUE SYNDROME

    * ‍FIRST COMMERCIAL SIZE BATCH OF AMPLIGEN, WHICH WILL CONTAIN ABOUT 8,300 VIALS, IS ANTICIPATED TO BE AVAILABLE IN MAY


    https://uk.reuters.com/article/brie...canada-to-treat-me-cfs-patients-idUKFWN1RH0GQ


    https://globenewswire.com/news-rele...ramme-to-Canada-to-Treat-ME-CFS-Patients.html
     
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  2. Trish

    Trish Moderator Staff Member

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    From this link:
    https://globenewswire.com/news-rele...ramme-to-Canada-to-Treat-ME-CFS-Patients.html

    I note that there has not yet been a stage 3 trial. Given the experience with Rituximab apparently working in early trials, then failing at the Stage 3 large double blind trial hurdle, I'm surprised Ampligen is getting approval in so many countries.
    I found this information about the planned US trial which I note is open label.
    https://clinicaltrials.gov/ct2/show/NCT00215813

    There are lots more details about Ampligen on MEpedia:
    http://me-pedia.org/wiki/Ampligen
     
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  3. Jaybee00

    Jaybee00 Established Member (Voting Rights)

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    Hmmmm wonder what the price will be? How long until you know if it is working? Like 1 month?
     
  4. Melanie

    Melanie Senior Member (Voting Rights)

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    It's being used in a lot of countries and many agreements for future distribution have been reached. http://me-pedia.org/wiki/Marketing_History_of_Ampligen#Marketing_history

    Argentina patients are able to get it. The FDA is pretty much sitting on its butt and could easily have trials but would rather limit it to letting only 100 patients at any given time use it and all out of pocket.

    Information on Phase III trial.

    https://globenewswire.com/news-rele...-Phase-III-Trial-in-Patients-with-CFS-ME.html


    In the USA it was about $25K a year out of pocket but now it is about $45K. The FDA is basically standing in the way of any research or distribution in the US.

    I hear that one or two transfusions and some PwME can begin to feel better but it is definitely a long-term treatment (I think forever). Cort Johnson has written about it.
     
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  5. Dolphin

    Dolphin Senior Member (Voting Rights)

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    Is it actually being used in other countries? I have seen loads of press releases over the years but have not heard of many patients having access to it outside the US and Belgium where Kenny De Meillier offered it for a number of years a while back.
     
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  6. Allele

    Allele Senior Member (Voting Rights)

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    Who in Canada would like to marry me?
     
  7. Melanie

    Melanie Senior Member (Voting Rights)

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    I think Argentina is as it was approved for use there. Now, if we just knew how to contact our Argentine PwME in their Spanish, Italian, and Levantine Arabic dialects to ask.

    The US does have it but for only 100 patients at a time, out of pocket, per the FDA.
     
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  8. Dolphin

    Dolphin Senior Member (Voting Rights)

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    My guess is that if it is available in other countries, in most/nearly all/all cases it will also be based on people paying themselves at this time.
     
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  9. Milo

    Milo Senior Member (Voting Rights)

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    Back on PR forum last year, an Argentinian patient with ME mentioned that while it Ampligen was approved in her country, there was no doctor actually recognizing the disease and therefore willing to embark on the process of offering it to their patients. She said that there was very little patient organization there.

    So while Hemispherx may be boasting they have been approved, it doesn’t mean that patients are receiving it, at least for the ME designation.

    The big problems with Ampligen is that it is expensive, you need to be on it for years at twice weekly hour(s) long infusions (requires nursing time) and you may not know for months whether you are a responder. FDA has rejected the application and some of our own experts voted it down, feeling that the evidence of efficacy was not very strong. Some have been helped significantly by this drug, while we have not heard much for those whose course of illness remains similar +/- placebo effect.

    It still remains that we do not have biomarkers of the disease, and we still don’t know the mechanism of illness.

    All that said, i would not be adverse to give this medication a good trial since it is definitely much better than sitting at home or attending CBT classes, but i would expect my health care system to cover all cost related to the infusions, comsidering that they do for drugs for patients with rheumatoid arthritis, cancer, HIV, Hep C, etc.

    Lastly, I keep on wondering, what comes first, a medical specialty or a drug? Competent physicians capable to monitor a complex drug, or an approved drug, and a couple of ‘cowboy physicians’ wanting to help but not knowing exactly what they are getting into and learning as they go? There are no right answers here, and i totally understand both sides, the safety issue, the risks from the health care side, and t he despair of patients like me willig to do anything to have a chance at getting better. I totally understand that status quo is unacceptable.
     
    Last edited: Apr 5, 2018
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  10. Melanie

    Melanie Senior Member (Voting Rights)

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    Yes, very expensive. I know when the price was rasied about a year ago Jen Brea said that there were patients that would have to stop using it. So she does know some who are on it and I think Ryan Prior is one of them.
     
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  11. MErmaid

    MErmaid Guest

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    Congratulations Millions Missing Canada!! :emoji_champagne::emoji_champagne_glass: :emoji_confetti_ball:

    Great job on the advocacy work to bring this to fruition!!

    I hope, by adding Canada, it better enables Hemispherx to target a subgroup that are Ampligen responders.
     
  12. John Mac

    John Mac Established Member (Voting Rights)

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    https://globenewswire.com/news-rele...ial-Sales-and-Expanded-Clinical-Programs.html

     

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