New Ampligen Clinical Data TOMORROW

Discussion in 'Fibromyalgia Main Forum' started by outofstep, Mar 18, 2009.

  1. outofstep

    outofstep Member


    Philadelphia, PA, Tuesday, March 17, 2009: Hemispherx Biopharma, Inc. (NYSE Alternext US: HEB) has scheduled a conference call and audio webcast to discuss its year-end 2008 results and the new clinical data recently presented at the 9th International IACFS/ME conference held in Reno, NV from March 12 – 15, 2009. The conference call and webcast are scheduled for Thursday, March 19, 2009 at 10:00 AM EDT.

    At the 9th International IACFS/ME conference, Dr. David Strayer, Hemispherx’s Medical Director, presented new, never before released cytokine data and cardiovascular data which has been included in the New Drug Application (NDA) filed with the Food and Drug Administration (FDA) with a current PDFUDA date of May 25, 2009. Dr. William Carter, Hemispherx’s Chairman and CEO, will discuss the data and its significance on the conference call. The presentation given by Dr. Strayer at the conference is available for review one hour prior to this conference call on the company’s website at

    To access the conference call:
    U.S. Callers: 800-346-7359
    International Callers: 973-528-0008
    Conference Entry Code: 520147

    This call will be webcast via the Company’s website at:

    A digital replay of the call will be available for until April 2, 2009 by calling:
    U.S. Callers: 800-332-6854
    International Callers: 973-528-0005
    Conference Entry Code: 520147

  2. mezombie

    mezombie Member

    Wow, Outofstep!

    Great find! I can't wait to hear the news!


  3. outofstep

    outofstep Member

    I guess obsessively checking the Hemispherx website finally paid off :)

    I can't wait either and just hope that it's good news for a change...
  4. mezombie

    mezombie Member

    and bumping for others.

    People are still interested in this, aren't they???
  5. outofstep

    outofstep Member

    Fingers crossed the FDA will think so too.
    I'm reposting a new Prohealth article about it for others:

    Slides of Ampligen® Trial Results Used in Presentation at IACFS/ME Conference

    March 19, 2009

    Ampligen® is an investigational, intravenously delivered drug that has been tested in clinical trials involving ‘chronic fatigue syndrome’ (ME/CFS) patients for years. It is classified as a toll-like receptor (TLR) activator, which means its mode of action would be as an agent that activates TLRs to induce immune cell responses to pathogens.

    Ampligen’s maker, Hemispherx Biopharma (HB), awaits the FDA’s decision on its New Drug Application, due May 25. And recently HB's Medical Director, Dr. David Strayer, presented the latest trial findings at the 2009 IACFS/ME Conference (Mar 12-15) in Reno. The trial involved patients treated at 12 clinical sites in the U.S.

    You can now click through the slides Dr. Strayer used in this presentation, at HB’s website ( (At the same time you will hear audio, not linked to the slides, from a webcast the company held Thursday Mar 19 to discuss its year-end 2008 results.) You’ll have a choice of versions employing Windows Media Player or RealPlayer.

    The Title of the Slide Presentation:
    “Interferon and Cytokine Levels in a Double-blind, Randomized, Placebo-controlled Phase III Clinical trial (AMP-516) of Poly I: Poly C12U (Ampligen®) in CFS.”

    Authors: Strayer DR, Stouch BC, Horvath JC, Stevens SR, Carter WA. Hemispherx Biopharma Inc., Philadelphia, Pennsylvania; University of the Pacific, Stockton, California.

    Investigators at the 12 sites: Drs. Bateman, Bellesorte, Cimoch, John, Keller, Lapp, Mercandetti, Peterson, Papernick, Podell, Stein, Taylor.

    A Few Notes:
    • Trial subjects were diagnosed with CFS, duration at least 12 months, and fell between 40 and 60 on the Karnofsky scale of functional impairment.

    • Ampligen (or placebo) was delivered via IV infusions lasting about 30 minutes, twice weekly for 40 weeks.

    Measured results included:
    - Treadmill test of peak exercise duration
    - Change from initial use of concomitant medications related to CFS

    Mean (average) results for exercise duration (change from baseline to week 40):
    - For those receiving Ampligen - improvement from 576 seconds to 672 seconds.
    - For those receiving placebo – improvement from 588 seconds to 616 seconds.

    More specifically, the mean percent of subjects who improved exercise duration:
    - At least 25% - was 39% with Ampligen, vs. 23% with placebo
    - At least 50% - was 26% with Ampligen, vs. 14% with placebo

    Decrease in use of medications (decrease in number of days individual medications were taken during weeks 36-40 of study vs weeks 1-4):
    - 72% of Ampligen group reduced medication use, vs. 56% of placebo group
    - 26% of Ampligen group did not decrease med use, vs. 44% of placebo group

    * * * *
    Visit for more detail.
  6. skeptik2

    skeptik2 Member

    Did they do ANOTHER one 24 hours later?

  7. outofstep

    outofstep Member

    Not sure what you mean but they are measuring improvement over time, so they are looking at the difference between the baseline level at the beginning of the study and then the performance level after 40 weeks of treatment. They're not doing treadmill tests after every infusion if that's what you're asking (although I don't know if they do interim tests) but the numbers reflect the difference (ie. improvement) between the baseline level and the exercise level post-treatment.
    [This Message was Edited on 03/19/2009]
  8. outofstep

    outofstep Member

    I think that it was developed at Johns Hopkins in the 1970s and was first used for CFS treatment in 1989. It's under review at the FDA right now and they will make some sort of decision by May 25th re: whether or not to approve it. It's only been available via clinical trials-the most recent trials have been open label, so in order to try it you had to pay for it and it's very expensive. It's an immune modulator and antiviral so the company that makes it (Hemispherx) thinks that it may be helpful for other diseases. There's TONS of controversy about the drug but it has been a lifesaver for some CFS patients. I want to try it b/c it's supposed to be effective against HHV-6.
  9. AuntTammie

    AuntTammie New Member

    I think Skeptik was referring to post exertional malaise....did they test two days in a row to see if it improved PEM?
  10. acer2000

    acer2000 New Member

    says according to the study that it didn't influence the cytokines they measured... interesting.
  11. outofstep

    outofstep Member

    You mean like the Pacific Fatigue Lab study? This study isn't looking at post-exertional malaise, just exercise duration.
  12. skeptik2

    skeptik2 Member

    I can "durate" all day today; but just see me tomorrow.

    The study says they test duration, but never mentions seeing the patient the next day, does it? Or testing the duration the next day?

    Maybe that's why they do treatments only twice a week. How often do they test duration of exercise? How often two days in a row?

  13. SpecialK82

    SpecialK82 New Member

    Is it just me or are these results underwhelming?

    I looked through the slide presentation (did not hear the audio yet) and I definitely don't understand all the science - but at the end of the day what do we have?

    I dont' see a great improvement over placebo - or am I misinterpreting? I wonder if the trial was longer if there would be more improvement? I wish they would have asked the patients how they felt at the beginning and the end, I know it's subjective, but I would be interested to know. For instance, did cognitive skills improve?

    I'm a little sad,


  14. skeptik2

    skeptik2 Member

    Underwhelming is the right word, IMHO.

    Dr. DeMierlier will be at the London InME conference at the end of May (see meZombie's post).

    If his treatment is not approved by then, expect a big "push" for it.

    I'll believe it when I see it approved by my insurance company.

  15. SpecialK82

    SpecialK82 New Member

    Have you seen any articles referencing DeMierlier's use of Ampligen? I have searched for it and haven't found anything.

    I'm excited to hear about his presentation in May.

    You're right that our really big day will be when a CFS treatment is approved by insurance!

  16. outofstep

    outofstep Member

    Not sure the FDA is too interested in qualitative data.

    PEM is also found in depressed patients-it's not unique to CFS.

    Hemispherx is in sort of an awkward situation-there are often viruses found in CFS, but the CDC says there aren't and so they aren't included in the case definition that the co. has to use. So the co. has to prove that Ampligen (an immune modulator/antiviral) helps CFS without acknowledging that there are viruses involved, which means that they can't exclude people from their studies just because they don't have viruses. This may explain their results.

    Dr. DeMeirleir was the lead investigator for the Brussels Ampligen study and reported an 80% recovery rate.

    I'm not trying to "recruit" anyone-just presenting info for those who are interested. As a 20 year CFS sufferer it's pretty encouraging that there is *any* CFS drug under review at the FDA. And if this is approved it will lend legitimacy to CFS as a disease and pave the way for more drugs to get approved (ie. ones being used for CFS overseas).
  17. emmally

    emmally New Member

    I think it will all come down to the toxicity and safety of the drug..
  18. SpecialK82

    SpecialK82 New Member

    You bring up good points that I did not think about.

    Do you think DeMierlier would have only chosen patients with viruses? I certainly hope that there was some sort of sub-typing ahead of time or alot of this could be relatively meaningless.

    How frustrating that we can't seem to get good quality scientific testing done on many of the CFS potential treatments.

    I agree with you that it's encouraging to have a CFS drug under review for all the reasons mentioned - I just hate to see something fail because there was no sub-typing.

  19. acer2000

    acer2000 New Member

    "PEM is also found in depressed patients-it's not unique to CFS."

    Really, can you provide some links? Because my CFS doc told me that one of the ways they differentiate primary depression from ilness is by measuring exercise capacity. Someone who is depressed shouldn't have a drastically reduced v.02 and AT, wheras someone who is sick with something that effects their metabolism would. I'm curious about that statement.
  20. karinaxx

    karinaxx New Member

    Hi Mezombie,
    How are you?
    After monthes not beeing once on the board, i thought i need to get updated and wow, do i need to get updated! What is going on with the Ampligen thing? FDA did a trial and is going to approve it? Or just another trial by HEM ? (they had so many in the nineties) And Meirleir is using it now? I have not seen him since 2007, did he change his treatments?

    Please update me and hope your all doing ok