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Ampligen success rate?

Discussion in 'General Treatment' started by Nielk, Jan 24, 2011.

  1. Riley

    Riley

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    Neil, what controversies are you referring to? I haven't come across a lot of negative info about ampligen, and the little I have found has been very sketchy.

    As per Dr. Mikovits, god bless her, but I'm going to need to see some hard evidence from her at some point. What she says about ampligen is the latest in a series of very bold claims that she has not backed up at all to this point. I mean, whose ampligen patients has she been studying and how are they measuring viral load?

    Again, I suppport Dr. M and the WPI 110%, but it's starting to feel like Waiting for Godot.
     
  2. LaurelW

    LaurelW Senior Member

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    I just watched the Gordon Medical videos yesterday, and what I remember her saying is that it does that in some people and not others, and they would like to figure out why, and which people would be likely to benefit from Ampligen. Right now there's no way to tell unless you take it. She also said in the people in which it does activate the virus, perhaps they could do combination therapy with other drugs. But it sounds like that's going to be down the road apiece.
     
  3. Nielk

    Nielk

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    See below from Wikipedia:

    Controversy

    Hemispherx has on two occasions received warning letters from the FDA regarding its promotion of Ampligen as safe and effective before approval from the FDA.[30][31]
    Manuel Asensio, an investment adviser who reports on companies he considers to be overvalued, has criticized Hemispherx and its Ampligen results,[32] alleging a variety of misdemeanors including accusations of refusing to supply Ampligen after clinical trials have ended,[33] and issuing misleading results to widen markets for Ampligen.[32]
    In 1998, Hemispherx Biopharma filed a complaint against Asensio and his company, alleging defamation, conspiracy and interference with its business relations through a short selling plot. After a jury rejected the defamation claims against Asensio, a mistrial was declared. Hemispherx announced in 2006 that they anticipated a new trial date to be set.[34]
    On November 2, 1999, Mary Schweitzer, a chronic fatigue syndrome patient who had been treated with Ampligen, raised the question of why Ampligen had never been fast-tracked by the US public health authorities at the Chronic Fatigue Syndrome Co-ordinating Committee of the U.S. Department of Health and Human Services.[35]
    In June 2009, The Street alleged Hemispherx was "seeking to divert investors' attention away from the delayed approval of Ampligen as a treatment for chronic fatigue syndrome" by issuing three press releases in seven days about research from 2007 into possible applications for Ampligen as a flu vaccine booster. Hemispherx stated that Ampligen could be used against the H1N1 swine flu. The Street also alleged the Hemispherx press releases were misleading because they imply the research had been done in 2009.[12] Hemispherx's attempts to put Ampligen in the H1N1 market were unsuccessful. The company stated they were "shut out of the U.S. government's efforts to stockpile vaccine against the H1N1 flu."[36]
     
  4. Riley

    Riley

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    Well this doesn't really affect my decision to pursue ampligen or not because it is controversy over the management of the company and possible stock manipulation. It has no bearing on the safety or efficacy of the drug.
     
  5. jonjonson

    jonjonson

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    First my disclaimer.... I own the stock....

    Second I consider wiki a horrible reference....


    <<Hemispherx has on two occasions received warning letters from the FDA regarding its promotion of Ampligen as safe and effective before approval from the FDA.[30][31]>>

    HEB isnt the only one who thinks ampligen is both safe and effective.... as far as the warning letters this happened more than a decade ago and since then the fda has issues hundreds of warning letters.... in short no controversy....


    Manuel Asensio, an investment adviser who reports on companies he considers to be overvalued, has criticized Hemispherx and its Ampligen results,[32] alleging a variety of misdemeanors including accusations of refusing to supply Ampligen after clinical trials have ended,[33] and issuing misleading results to widen markets for Ampligen.[32]
    In 1998, Hemispherx Biopharma filed a complaint against Asensio and his company, alleging defamation, conspiracy and interference with its business relations through a short selling plot. After a jury rejected the defamation claims against Asensio, a mistrial was declared. Hemispherx announced in 2006 that they anticipated a new trial date to be set.[34]

    He was a crook ....pure and simple he was found guilty of fraud and lost his securites license....

    <<On November 2, 1999, Mary Schweitzer, a chronic fatigue syndrome patient who had been treated with Ampligen, raised the question of why Ampligen had never been fast-tracked by the US public health authorities at the Chronic Fatigue Syndrome Co-ordinating Committee of the U.S. Department of Health and Human Services.[35]>>

    The simple fact is that the fda normally doesnt fast track drugs for diseases which do not directly cause death commonly.....


    <<In June 2009, The Street alleged Hemispherx was "seeking to divert investors' attention away from the delayed approval of Ampligen as a treatment for chronic fatigue syndrome" by issuing three press releases in seven days about research from 2007 into possible applications for Ampligen as a flu vaccine booster. Hemispherx stated that Ampligen could be used against the H1N1 swine flu. The Street also alleged the Hemispherx press releases were misleading because they imply the research had been done in 2009.[12] Hemispherx's attempts to put Ampligen in the H1N1 market were unsuccessful. The company stated they were "shut out of the U.S. government's efforts to stockpile vaccine against the H1N1 flu."[36][/QUOTE]>>

    Here is another crook.... this one works for short sellers....

    recall he also said heb would withdraw its nda...... the implication here is that heb had done something wrong......


    It was a lie meant to manipulate the share price.....pure and simple.....

    IMO for an unsubstantiated comment like that he should be in jail.....


    By the way adam the crook wrote that stuff not the street.....


    Then adam the crook talks about heb getting shut out of flu vaccine stockpiling.....


    How funny..... While showing great promise for h5n1 it was never tested specifically for h1n1..... so it getting closed out for stockpiling shows how clueless adam is.....



    If thats the best controversery you have there seems to be little to worry about.....



    Frankly it would be better not to pull guys lilke assensio and adam into a medical discussion......
     
  6. Nielk

    Nielk

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    I admit that I don't have clear and first hand information about Ampligen.
    I read the book "Patient 02" which is loosely based on the first open Ampligen study.
    What I know, is from patients who have taken it or been in the study.
    There is very conflicting reports and experiences with it.
    Some patients have improved tremendously yet I heard that when the study was over, Hemispherx did not provide them
    further Ampligen and they regressed. Some patients were not helped and others had adverse effects. This is I guess expected with any trial of medical trials.

    The reason I started this thread was to try to get more input as to the TRUTH about what happened.
    My doctor will soon be part of the new open study and before I take this big financial and physical burden, I want to make sure what I'm getting into.
     
  7. jonjonson

    jonjonson

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    I dont know if you have had the tests but those who produce antibodies to xmrv do the best on ampligen.....

    The reason I think is similar to the flu....the more antibodies you make the better protected you are.... old folks and others with inefficient immune systems do worse.....


    But there is also no way heb can supply ampligen to all who might want to continue taking treatments.... and the fda wants to know what happens after treatment completes....
     
  8. LaurelW

    LaurelW Senior Member

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    I was in the 516 study in 2003-2004, Nielk. I'll answer any questions you might want to ask.

    Are you XMRV positive? Hemispherx came out with a study last year saying that X+ people benefited more than negatives.
     
  9. jonjonson

    jonjonson

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    Here is my theory on that.....


    There was a question earlier about dr m comments that 1/3 of those who are treated with ampligen activate the virus.....


    That may be explained by the fact there are no xmrv antibodies waiting to attack the virus.....



    Dr M has also said in these cases it may be beneficial to follow ampligen treatment with antivirals like azt if viral activation occurs.....



    Standard treatment for those with antibodies may end up being ampligen alone....


    but where activation occurs ampligen to flush the virus out and azt to reduce replication.....
     
  10. LaurelW

    LaurelW Senior Member

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    That sound like what Dr. Mikovits was saying.
     
  11. jonjonson

    jonjonson

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    You are correct in saying that heb did a study which found that those who produce xmrv antibodies did better....


    DrM said that a third of xmrv patients who are treated with ampligen activate the virus.....



    What she doesnt say is that its quite as clear as testing for the presence of antibodies.....



    Based on the heb wpi study its clear that most of those whose xmrv infection is activated will be those who dont produce antibodies.....
     
  12. JohnnyD

    JohnnyD Senior Member

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    My disclaimer: I own the stock and have a sister who benefited from ampligen (in the 516, and is why I bought the stock).

    Riley, you are right to ignore the financial battle and concentrate on the science and research. I think the important thing is that Mikovits thinks the stratification of those who benefit (or don't benefit) from ampligen is important. They have been looking at this for some time, here is a Peterson powerpoint presentation on preliminary data down in October of 09 (I presume that is what the 1009 stands for. interesting that it resides on the HHS site)

    file:///C:/Documents%20and%20Settings/jdodson/My%20Documents/Downloads/peterson_1009_pt6.pptx

    by now, they have now done a retrospective study on a good part(or all) of the 516 trial and I cannot help but think they have a very good idea of the types of markers that stratify the patients. Hemispherx is preparing for another Phase 3, to be started in the 3rd quarter which I think would be ampligen only. Maybe a combo therapy for next year?
     
  13. LaurelW

    LaurelW Senior Member

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    "Hemispherx is preparing for another Phase 3, to be started in the 3rd quarter which I think would be ampligen only. Maybe a combo therapy for next year?"

    Hi Johnny--where did you hear this? I'm really interested and would like to know more.
     
  14. Nielk

    Nielk

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    I am still waiting for my results for XMRV.
    I don't know yet. I do know that I have high viral load in my body.
    I guess knowing for sure whether one is XMRV positive can help with the answer whether to try Ampligen.
     
  15. pine108kell

    pine108kell Senior Member

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    No one has even proven a link between CFS and XMRV. What's more, as far as I know, no one one has shown that Ampligen has any effect on XMRV. I don't know why a research scientist who, as far as I know, does not treat any patients, would make public speculations such as this.

    That doesn't mean Ampligen is safe or effective. I don't think Ampligen has a great track record--I have read a few success stories--but I would not base my decision on this kind of speculation about XMRV. If someone offered it to me free, I would probably take it.
     
  16. jonjonson

    jonjonson

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    You are aware are you not that heb is the only company to treat xmrv patients in a phase III????

    WPI did a retrospective study with ampligen.... very sound science..... blinded to be sent to the fda....


    which showed clearly ampligen had an effect on xmrv...


    I dont see why a research scientist who has the right data couldnt form an opinion if it works or not.....


    Your post seems narrow minded at best.....
     
  17. JohnnyD

    JohnnyD Senior Member

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    Hi Laurel,

    HEB filed the formal protocols in late November. Cater said in December that he believed by February or March they would have enough data from the retrospective (65-80%) to meet with the FDA. In a call and in an interview he is states 3rd quarter NDA submission. I understand that patients currently in the 511 are be asked for new consent forms for the new trial. you might check that info if you have contacts left from your participation in the 516. In my view the "widened enrollment" for the 511 is really preparation for the new trial, which will be looking at xmrv data. Here are some links.

    http://www.biopharmatoday.com/2011/...idation-of-chronic-fatigue-drug-reviews-.html
    http://hemispherx.net/content/investor/default.asp?goto=690

    Hi Pine. True... not yet anyway, but most think it is highly likely -- too many things add up.

    From the above, early retrospective data presented at the 1st XMRV conference showed that ampligen has an heightened therapeutic response on xmrv antibody+ patients. This is part of the retrospective analysis of HEB's 516, double blind placebo trial. The reason Mikovits knows about the data is that the WPI is doing all the blood work/testing for the retrospective... e.g. she's in the catbird's seat.
     
  18. jonjonson

    jonjonson

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    Let me give you my take on ampligen treatment.....

    If my sister had xmrv related cfs this is what I would say....

    I believe xmrv like other viruses can infect a person.....


    then go dormant.... an active immune system could keep the virus dormant for a long time without that person ever knowing they had the virus....


    The there are two other types of people who are more effected by the virus.....



    The type that gets the sickest for some reason do not produce antibodies to xmrv these people will be the most difficult to treat and they were also the ones who did the most poorly on ampligen..... however there is a treatment effect but I suspect treatment will be much longer......


    There are other folks who produce antibodies to xmrv.... ampligen apparently ampligen drives the virus from domancy where the antibodies and other defences can fight the virus.... the way this works I think is that ampligen stimulates tlr3 which produces low levels of interferons produced by your immune system as a response to ampligen the fake virus.....

    Ampligen simply turns on a cascade that occurs naturally to an infection.....




    The last year has in my mind clarified the why of a common statement I hear from patients.....


    I felt sicker before I felt better.....


    Now I get it....I think..... ampligen drives the virus out of hiding......


    Then if you have antibodies waiting you probably do quite well on ampligen....



    if you dont have antibodies you have basically stirred up a hornets nest....




    Probably the answer is to apply an antiviral at that point when the virus is exposed.....



    I think the work wpi and heb are doing is quite fantastic and I look forward to ampligen being a better treatment due to this new work mostly by wpi......





    But one thing folks should know about ampligen.....it isnt a real drug.... its a man made fake virus.....


    its like a rubber snake..... its job is to scare the immune system......


    since your immune system cant tell that ampligen isnt a virus.....


    Whatever happens after that is a result of what happens with your immune system.....



    I cant say it any other way..... its quite unlike most other drugs.....
     
  19. Riley

    Riley

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    I wish there was more data on who was likely to respond!

    My dilemma is that ampligen is pretty much my last option, and i am optimistic that it will work. The money is not a huge issue for me. However, my health is so bad and deteriorating so rapidly, that if I move to the trial site and do not respond or get worse, it will probably be the last thing that I ever do. I guess I'm just going to have to take a leap of faith or not.
     
  20. jonjonson

    jonjonson

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    I think I would want to know before treatment....

    Do you have xmrv infection...

    Do you produce xmrv antibodies.....


    would the doc consider the use of azt if xmrv titers increase.....
     

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