Review: 'Through the Shadowlands’ describes Julie Rehmeyer's ME/CFS Odyssey
I should note at the outset that this review is based on an audio version of the galleys and the epilogue from the finished work. Julie Rehmeyer sent me the final version as a PDF, but for some reason my text to voice software (Kurzweil) had issues with it. I understand that it is...
Discuss the article on the Forums.

Hemispherx news, IOM, SEID, Ampligen stress test results

Discussion in 'Institute of Medicine (IOM) Government Contract' started by Nielk, Feb 23, 2015.

  1. Nielk

    Nielk

    Messages:
    6,877
    Likes:
    10,615
  2. Bob

    Bob

    Messages:
    9,844
    Likes:
    33,947
    England (south coast)
     
    SpecialK82, oceiv, Anne and 1 other person like this.
  3. JohnnyD

    JohnnyD Senior Member

    Messages:
    205
    Likes:
    486
    HEB and the FDA changed the AMP511 cost recovery trial protocol in November - you can read the changes on clinicaltrials.gov. So the NK clinical testing has been underway since November. There are now three arms to the trial, each with 100 in each arm. 100 ME patients getting ampligen, 100 ME patients not getting ampligen and 100 healthy controls. They measure NK function and compare the arms. The advantage is that you can tell pretty quickly if ampligen is improving NK function or not. So they could stop the testing or advance the testing at any number of patients. The other advantage with this design is that the FDA just saved Hemispherx 20-30 million dollars over the traditional double blind, placebo controlled phase III trial of 600 patients - which is what the FDA originally wanted. Hemispherx has lots of historical data to show NK improvement, the FDA of course wants to see it in real time. Some of the literature showing NK cell function in ME patients goes back to 1998. I think the FDA is going to want to finally catch up.

    Hemispherx did good. I think they can show that ampligen improves NK function and that this will lead to an advanced trial under FDASIA rules, probably a phase IV.
     
    NK17, SpecialK82, Anne and 4 others like this.
  4. SpecialK82

    SpecialK82 Ohio, USA

    Messages:
    992
    Likes:
    819
    Ohio, USA
    Very exciting!
     
  5. Bob

    Bob

    Messages:
    9,844
    Likes:
    33,947
    England (south coast)
    Anne likes this.
  6. Bob

    Bob

    Messages:
    9,844
    Likes:
    33,947
    England (south coast)
    Anne, NK17 and catly like this.
  7. NK17

    NK17 Senior Member

    Messages:
    592
    Likes:
    1,517
    These are exciting news, thanks for posting @Nielk @JohnnyD and @Bob!
    Things seem to finally start moving somehow for us.
     
    Last edited: Mar 6, 2015
    Bob likes this.
  8. Snow Leopard

    Snow Leopard Hibernating

    Messages:
    4,615
    Likes:
    12,454
    South Australia
    I don't quite understand why they are testing NK cell function, when it is efficacy on symptoms/level of functioning that they are supposed to be demonstrating.

    Measuring NK Cell function would only be useful, if it was a biomarker which could be used to determine who would respond to the drug or not.
     
    usedtobeperkytina likes this.
  9. Anne

    Anne Senior Member

    Messages:
    295
    Likes:
    723
  10. Sasha

    Sasha Fine, thank you

    Messages:
    12,789
    Likes:
    34,217
    UK
    I posted a thread about that some days ago - Bob Miller will be commenting at some point.

    It's had some very interesting discussion:

    http://forums.phoenixrising.me/inde...ampaign-to-request-hearing-on-ampligen.36030/
     
    NK17, Bob and Anne like this.

See more popular forum discussions.

Share This Page