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Hunting down the cause of ME/CFS & other challenging disorders - Lipkin in London
In a talk to patients in London on 3rd September, Dr. W. Ian Lipkin described the extraordinary lengths he and his team are prepared to go to in order to track down the source of an illness, with examples ranging from autism to the strange case of Kawasaki disease.
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First Ampligen, second antiretrovirals?

Discussion in 'Antivirals, Antibiotics and Immune Modulators' started by Berthe, Nov 11, 2010.

  1. JohnnyD

    JohnnyD Senior Member

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    Hi Sasha, the company has had a bumpy road, some of it their fault and some not.... but I think no one would like to see ampligen approved more than the company itself. Much of he distant history is outlined in "Oslers Web" and much of the "bad management" rap comes from short sellers trying to down the company for their financial benefit - which is criminal, the short sellers should be put in jail. I have no problems with management the past 5 years.

    I don't give investment advice, but let me give you a different perspective. The company is small, it usually take a billion dollars to develop a drug, Hemispherx has spent over half a billion trying to commercialize ampligen. It ain't cheap or easy. ME/CFS is the largest unmet medical need in this country and no other biotech's are actively trying to develop drugs for ME/CFS. In 1997 Hemispherx undertook ME/CFS trials, a disease of unknown etiology, with no standard diagnosis with a drug whose mechanism of action was little understood. This is remarkable... astounding. In 2005, the mechanism of action was discovered - ampligen is a Toll-Like-Receptor 3 agonist. (TLR-3 is a viral pathway). In 2009 the ME/CFS connection with XMRV was discovered. The company recently ran a retrospective on their Phase III data, they had the WPI test trial participants for XMRV and found that 97% of the XMRV+ participants improved greater than/or equal 25% in ETT (treadmill test), (67% of the XMRV- participants had the same improvement) .. improvement was from baseline. This is a new endpoint, which according to the company has the FDAs blessing. The old endpoint was from the average mean baseline. Big difference. The company intends to undertake another Phase III and if those numbers hold, the chances of approval, IMO, are great.

    Ampligen is no cure, but it does alleviate symptoms in about 70%. Dr. Lapp has good insight in this article and he should know. http://ampligen-treatment.blogspot.com/2010/10/interview-with-dr-lapp-pioneer-and.html

    So Sasha, don't knock Hemispherx too much - so far, they are the only biotech actively working on getting a beneficial drug approved for ME/CFS. Peterson and Lapp believe that in future trials, ampligen will be combined with anti-retrovirals - which sounds like the best hope for ME/CFS sufferers.
     
  2. Sasha

    Sasha Fine, thank you

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    Hi Johnny - thanks for the background on Ampligen, I didn't know any of that - perhaps I am being too harsh on them. But it is frustrating to see them trying to do a cost-recovery trial when they must be aware what effect the illness will have had on the finances of patients ill enough for long enough to want to try an experimental treatment like this. It could take years for enough patients who can afford it to come forward. Surely at this stage it would be worth what to them would be a small investment?
     
  3. JohnnyD

    JohnnyD Senior Member

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    I agree Diesel. There is s growing realization that the regulatory process leaves much to be desired as far as orphan drugs go. Apparently there are changes in the works. See this article. Had these changes been implemented in 1997, ampligen would be approved.
    http://www.genengnews.com/analysis-and-insight/changes-brewing-at-the-fda-for-orphan-drugs/77899338/

    Sasha, running trials is not a small investment - 50-100 million per trial. It is a commercial, publicly owned company, they must justify expense to stockholders. The new cost recovery centers that they are looking to open, I believe, are really a 'gearing up' for their new phase III trial. IOW, the centers that run the 511 cost recovery, will also be the centers that run the new phase III... should they come to terms with the FDA. The best way to get the drug affordable is to gain approval, with insurance picking up much of the tab.
     
  4. Sasha

    Sasha Fine, thank you

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    Depends on the trial - I thought they were talking about 700 patients (see m0joey's post #15 on this thread), half on placebo so that's 350 on Ampligen at $20,000/year (the sum quoted for a cost-recovery basis) so $7 million for drugs, chuck in a bit more for admin & supervision, call it $10 million. I call that peanuts, given that it's in Hemispherx's own interests to do this.

    Happy to be informed if I'm making some miles-off assumptions about my figures, though - struggling to see where $100 million could be spent.
     
  5. JohnnyD

    JohnnyD Senior Member

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    Sasha, I'm not going to go into financial analysis on this forum... or go over all the costs associated with drug development. You can google "cost of clinical trials" for an idea. The company's financial reports are available online in the form of SEC documents. I will say though, that having spent 500+ million so far to develop ampligen - the company knows where it's interests lie.

    Thanks.
     
  6. Frank

    Frank Senior Member

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    This is probably Nexavir and/or GcMAF
     

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