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Article: Ampligen Study Sparks Hopes for FDA Approval of First Drug for CFS

Discussion in 'Phoenix Rising Articles' started by Phoenix Rising Team, Mar 18, 2012.

  1. Phoenix Rising Team

    Phoenix Rising Team

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  2. Evangelina

    Evangelina

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    Cort - Where did you get your information from? As a patient receiveing Ampligen at one of the testing sites you mentioned and paying for it My doctor didn't know Hemispherx was running a double blind study! This drug is insanely expensive for my family and I know of patients at other sites who were / are struggling as well.
    Would you please tell me - which doctors specifically ran this study? Also is it true that the patients did NOT pay for the drug? And when was Hemispherx going to break the news to those of us sweating blood to pay for this drug that they were giving it away?
  3. JohnnyD

    JohnnyD Senior Member

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    This article is so I'll-informed and full of disinformation , it should be taken down.

    This peer reviewed paper is about Hemispherx's pivotal AMP516 trial, which began in 1998 and was fully enrolled in 2004. There is new information in the paper, but Cort somehow misses it. You can download the paper Here

    http://www.plosone.org/article/info:doi/10.1371/journal.pone.0031334
  4. LaurelW

    LaurelW Senior Member

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    The 516 trial finished doing the patient studies in 2004. The drug was free at that time but has not been free since then.
  5. Evangelina

    Evangelina

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    Whoops! My bad everyone! I just looked at Cort's date of publication - not the study dates. This study is really old. Thanks for the clarification everyone! :) E.
  6. Cort

    Cort Phoenix Rising Founder

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    ????? Most of article was straight from that paper. To be honest I was confused with the statement that the trial began in 1998 and ended in 2004...That suggests that Hemispherx simply re-analyzed their old data - which I imagine is not going to go over well with the FDA...

    With that fact noted I agree that, if this is old data that is simply being re-analysed or analyzed for the first time, then several of the statements are wrong and I'm redoing it. I just could not understand how Hemispherx could provide data now from a study that was done 8 years ago. Hemispherx needs to respond to the FDA's reasons for denial - thats the only way it will win approval and it took out an extension to do that.....when this paper came out I assumed that this was their response...but if the data is from a study from 8 years ago, it appears that either it wasn't their response or they concluded that they could dig data out of that old NIH study which would satisfy the FDA's concerns. I would guess the answer is more the second.

    This is the kind of thing that has outraged outside evaluators of Hemispherx for years. Feuerstein did a long article on the changes in results that Hemispherx presented for the same study and concluded that Ampligen will never win approval so long as this kind of stuff was going on.
  7. Cort

    Cort Phoenix Rising Founder

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    The information came from the PLOS One Paper. The Doctors involved were co-authors of the paper - they included Dr. Peterson, Dr. Bateman and Dr. Lapp I believe.
  8. Firestormm

    Firestormm Senior Member

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    It is interesting to note that little (if any) media coverage of these results has taken place. Whether or not that is an indication of them being a 'rehash' of the previous work I don't know. But even Feuerstein has been silent.

    The stock price did see a bounce on abstract publication in January - at least I presumed the two were connected - but since then (and with full publication) definite signs of 'profit-taking'.

    Even if this paper's results are considered 'not very much to shout about' you'd think someone would be shouting i.e. the company. So I'm not really sure what that tells us, but how can a trial from 2004 be re-analysed in this way without doing it all again?

    Weird.

    Still, on the basis of the reported results the ET scores do appear notable especially in relation to previous FDA studies.

    It's also noticeable that a drug is being looked at in this way i.e. exercise tolerance when such things are usually reserved for less objective GET practices for example.

    I wonder if this is something that is unique to our condition? Will Rituximab etc. have to similarly prove improved ability in this way? Is it a fair objective measure?

    I would have liked more information about the drugs that patients felt able to reduce or stop however, and - whilst not perhaps germane to this study - it would have been useful to see more data on the immune profiles of those involved.

    What is Ampligen doing to the patient's body? How is it beneficial? Like Rituximab I feel they are missing a key stage here and potentially jumping ahead of something they will be called upon.

    Unless of course a past study of theirs has revealed this - in which case if someone could point me to it I'd be grateful.

    Thread here:http://forums.phoenixrising.me/show...shed-in-PLoS-One-14mar2012&highlight=ampligen
  9. Cort

    Cort Phoenix Rising Founder

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    It is weird. As I researching Ampligen every announcement has shown up in the media quickly but there's been nothing in the media at all about this study. Upon recollection most of them were based on press releases from Hemispherxand its possible Hemispherx did not do a press release.

    I can see a couple of options...Hemispherx doesn't have the money to spend on a new study - they had to re-analyze their old data...Hemispherx has the money but doesn't want to spend it on a new study - they believe a re-analysis of their old data is sufficient....(they jumped quickly into the XMRV stuff so they have some money but clinical trials are really expensive...)...Hemispherx has another study/more information that they haven't shown yet...

    These are the 'con-committant' drugs the patients were using according to table S9 in the report. I was surprised that the list wasn't much longer - there were about 200 patients in the study.....


    Analeptics Provigil (modafinil)
    Analgesics Darvon (propoxyphene)
    Anticonvulsants Neurontin (gabapentin)
    Antidepressants Prozac (fluoxetine)
    Antihistamines Atarax (hydroxyzine)
    Anti-infectives Zithromax (azithromycin)
    Anti-inflammatories Advil (ibuprofen)
    Antipyretics Tylenol (acetaminophen)
    Hypnotics Ambien (zolpidem)
    Firestormm likes this.
  10. SpecialK82

    SpecialK82 Senior Member

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    I was taking Ampligen in 2010 & 2011, from what I gathered about the 300 person study, I believe that they re-designed it after the XMRV news broke in 2009. They always knew that Ampligen worked for some and not for others, and now they thought they may know why, XMRV+ patients may be the ones who responded.

    So they took time to redesign and work with the WPI to be able to detect XMRV. They had a big meeting in Florida a little over a year ago with all the doctors/nurses who worked with Ampligen. In part, I believe to gear up for the big study and to change testing protocals, one was the inclusion of XMRV testing in study participants. I was even XMRV tested through HEB, although I had already started the drug.

    Fast forward to news of when XMRV theory fell apart. I think this threw a wrench into their study plans - again. Did it have to be redesigned? They were constantly behind the curve. They can't keep up their studies as fast as the science was changing in this area.

    I don't know if we would have the 300 person study going yet, if XMRV wasn't in the mix, but I believe, at the least, it was a huge distraction for HEB.
  11. santi

    santi

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    The Rituximab only works on some cases and still we don't know why.

    Furthermore shutting down the immune system would relief the symptoms but as well leave us unprotected from infections and external aggressions because of the immune system shut down itself.
  12. Cort

    Cort Phoenix Rising Founder

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    I think one criticism of Hemispherx is that they've jumped all over the place looking for ways for Ampligen to fit in. In some ways that makes sense since it's an immune activator but if alot of money was wasted with XMRV - that's a real shame.
  13. biophile

    biophile Places I'd rather be.

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    There are online anecdotes about the wonders of Ampligen, maybe for some people it is pretty good. However, as much as I am suspicious of subjective measures in unblinded trials of psychotherapies aimed at changing ME/CFS patients' cognitions, the self-reported measures in this double-blinded Ampligen study were very UNimpressive.

    I wish they also used healthy controls for the exercise test for a better comparison with what is normal, as it may be like the 6 minute walking test distance in the PACE Trial where an extra 35 meters or so for GET may sound impressive until you realize that a normal healthy score is an additional 300 meters. I personally couldn't afford or justify $20K/year or whatever for a mere 16% increase in my current pathetic exercise capacity, especially if I don't feel any better subjectively, and I'm sensitive to side effects so it all sounds too risky.

    Spontaneously reduced medication usage could be a good sign, unless of course the reduction was due to adverse effects of the Ampligen.
  14. niall

    niall

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    As Hemispherx is a small company they cannot provide Ampligen for free in this current clinical trial. The FDA is now requiring approx. 200 patients in this ongoing clinical trial but that is going to take a long time as the cost is prohibitive. If the are able to use some of the data in their past studies, that would help a great deal in gaining FDA approval
  15. niall

    niall

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    I am now almost finished five months of Ampligen and I am happy to report that there is a decided improvement in my ability to tolerate sustained activity. I still have all of my symptoms but I do not crash anymore even if I have to be active for four or five hours a day.

    It is my belief that those patients who can tolerate Imunovir and respond well to it will have a favorable response to Ampligen. Those who cannot tolerate Imunovir may have trouble with Ampligen too
  16. Firestormm

    Firestormm Senior Member

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    A couple of media items hit my inbox today:

    Is Hemispherx Finally seeing the light at the end of the tunnel: http://www.smallcapnetwork.com/Is-H...e-Tunnel/s/via/10/article/view/p/mid/2/id/83/

    Marketwatch: http://www.marketwatch.com/story/he...nr-in-chronic-fatigue-syndrome-cfs-2012-03-19

    Stock appears to now have bumped up 10% or so. Funny that it takes media coverage (apparently) to achieve this and not the actual release of the paper. I guess it takes even analysts these days some time to figure it out.

    'Biotechnology stocks are a funny and diverse breed. Many of them are one-trick ponies working on the development of one drug. If that drug is approved it could be a blockbuster, but if it's not approved, the company's continued existence is pointless.

    Other biotech outfits go to the other extreme, working on anything and everything, but not doing any of them very well due to a lack of focus. These companies burn a lot of money, but end up with nothing revenue-bearing because it couldn't develop anything meaningful.

    Hemispherx BioPharma, Inc. is somewhere in the healthy middle, working on a potential blockbuster to treat chronic fatigue syndrome, but also developing something of a cash cow with Alferon. In fact, the market may be entirely missing the boat with Alferon. It is approved in the United States, but the reason it doesn't seem to be positively impacting the company is that it's not being sold yet. ...

    ...Make no mistake. Ampligen is still the 'big deal', and is still a big question mark. The FDA has given the company all the time it needs though, and considering the chronic fatigue syndrome market is also a multi-billion-dollar market. Like the genital warts market, the lack of convincingly-proven treatment means there is no clear annual 'spend' on CFS, so the specifics are unclear. Again though, even a treatment that works reasonably well for a mere handful of chronic fatigue sufferers could be a game-changer for the company's shareholders.

    While there's no timeframe for when the company might file an NDA with the United States' FDA, today's announcement implies it could be soon. Hemispherx BioPharma shared some encouraging data regarding the treatment's success with CFS that leans towards a positive nod with a future FDA filing....and the agency has already tacitly suggested it's looking for ineffective treatment for the debilitating disease. Even with an excessively-eventful past, HEB looks to be a frontrunner in that race, and could be worth a swing.'

    Be nice to hear from other sources methinks.
  17. Firestormm

    Firestormm Senior Member

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    Hemispherx Biopharma, Inc. to Host 2011 Year End Conference Call on Thursday, March 22, 2012

    Press Release: Hemispherx Biopharma, Inc. 1 hour 34 minutes ago


    PHILADELPHIA, March 20, 2012 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company"), has scheduled a conference call and audio webcast on Thursday, March 22, 2012 at 10:00 a.m. (Eastern Time). The conference call will discuss its year-end 2011 results of operations and will also focus on the Company's Chronic Fatigue Syndrome program as well as advances at the New Brunswick manufacturing facility.

    Company executives will conduct a question and answer session following their remarks.

    To access the conference call:
    U.S. Callers: 800-346-7359
    International Callers: 973-528-0008
    Conference Entry Code: 27781

    This call will be webcast via the Company's website at: http://www.hemispherx.net/
    The webcast and a digital telephone replay will be available approximately one hour after the conclusion of the call for two weeks until April 5, 2012 by dialing:

    U.S. Callers: 800-332-6854
    International Callers: 973-528-0005
    Conference Entry Code: 27781

    http://www.mecfsforums.com/index.php/topic,11659.msg133341.html#new
  18. MishMash

    MishMash *****

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    I don't understand the chemical process by which Ampligen acts as an immune activator. I thought it was supposed to be an immune modulator? I know that Rituximab works as a monoclonal antibody that targets a protein found on B cells. Can anyone explain in concrete terms the way Ampligent works? I've been following the development of this drug for may years, and this information has never been explained.
  19. HTree

    HTree

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    Cort /All : could you lead me to, or relay, a quick analysis of Ampligen vs. Immunovir? they are both immune-modulators, etc, I know. I am wondering why some folks are recommended to try versus the other, from what you hear? Also, have you written about Immunovir at any point? (In my quick search, I did not see...)
    Appreciate any time you have...Thanks. Htree
  20. Firestormm

    Firestormm Senior Member

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