New Atmosphere, New Vision: Gibson and Whittemore Kick Off Invest in ME Conference 2016
Mark Berry reports on Dr. Gibson's introduction and Dr. Whittemore's keynote speech, at the 11th Invest in ME International ME Conference in London.
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Phase III trial of antiviral + antinflammatory combo

Discussion in 'Latest ME/CFS Research' started by natasa778, Nov 15, 2014.

  1. natasa778

    natasa778 Senior Member

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    Apologies if already posted ... Also note to admin: I wasn't sure if this is the right forum section so feel free to move to Other Health or wherever you see fit. The trial is for fibro but chronic fatigue as a symptom that is helped by this treatment is mentioned a lot ...

    http://www.as.ua.edu/home/professor-surgeon-team-headed-to-third-phase-clinical-trials/


    Carol Duffy is proof that changing your mind is not only acceptable, but that doing so can often lead to something momentous. Duffy, an associate professor in the Department of Biological Sciences, is headed somewhere that very few faculty members have the chance to go – to a third phase clinical trial for a drug combination that has shown promising results to treat not only one, but several painful and debilitating illnesses.

    ....
    Their biggest challenge, as Duffy saw it, would be to show that the virus is causing the symptoms. Chronic gastrointestinal conditions such as peptic ulcers have been considered bacterial infections for decades and are often treated with antibiotics. Fibromyalgia, on the other end of the spectrum, has been thought to originate in the nerves and muscles, causing pain. Duffy needed to show that these patients’ symptoms – things such as extreme pain, sleep disturbance, exhaustion, and headaches, among others – were being caused by an immune system response to a virus.

    “I told him I wanted to see the tissue because nobody is going to believe us unless we show that the virus is there,” she said.


    ... By May 2013, they had raised enough funds to start a small-scale, second phase trial, which they finished in January. By March, they had raised a total of $5 million. Despite the trial’s small scale – they enrolled a little more than 140 people – Duffy says the results were incredible. They were so promising, in fact, that the duo has continued to convince key players in the field to join their cause.

    ... As Duffy and Pridgen look to conduct a series of larger-scale, third phase clinical trials – a cost they’ve estimated to be $50-$100 million – they are searching for the quickest, most cost effective way to get their treatment to market. ... “Even with the smaller dose that we used in the phase two trial, we had great results,” Duffy said. “But if the FDA is going to approve our drug combination, we want it to be at the dose that’s going to help people the most.”
     
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  2. natasa778

    natasa778 Senior Member

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  3. heapsreal

    heapsreal iherb 10% discount code OPA989,

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    I wonder what other anti inflammatories may work?
     
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  4. natasa778

    natasa778 Senior Member

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    Since it is Cox-2 they are inhibiting here, I am wondering about plain old ibuprofen?
     
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  5. heapsreal

    heapsreal iherb 10% discount code OPA989,

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    WASHINGTON, DC – March 21, 2013 – The over-the-counter anti-inflammatory drug naproxen may also exhibit antiviral activity against influenza A virus, according to a team of French scientists. The finding, the result of a structure-based investigation, is published online ahead of print in the journal Antimicrobial Agents and Chemotherapy.



    New influenza vaccines must be developed annually, because the surface proteins they target mutate rapidly, the way cars used to get a whole new look every year. The researchers, led by Anny Slama-Schwok of the Institut National de la Recherche Agronomique, Jouy en Josas, France, found a much more stable, reliable target for anti-influenza activity. The so-called ribonucleoprotein complexes are necessary for replication, and the researchers realized they could target the nucleoprotein, preventing assembly of the complexes. Because of its vital function, the nucleoprotein is highly conserved, making it a good potential target for antiviral drugs.



    The nucleoprotein’s three dimensional structure, solved in 2006, provided the basis for searching for new drugs that could interfere with its action. The researchers did a virtual screening within the Sigma-Aldrich online catalog of biochemicals. That screening identified Naproxen, better known as the over-the-counter pain reliever Aleve, and as expected, it bound to the nucleoprotein, and impeded RNA binding, says Slama-Schwok. In further testing, it reduced the viral load in cells infected with H1N1 and H3N2 influenza A virus, and in mice it demonstrated a therapeutic index against influenza A that was superior to that of any other anti-inflammatory drug.



    Specifically, naproxen blocks the RNA binding groove of the nucleoprotein, preventing formation of the ribonucleoprotein complex, thus taking the vital nucleoproteins out of circulation. The researchers write that naproxen is a lead compound for drug development that could be improved by tweaking the molecule to boost its ability to bind to nucleoprotein.



    As an already approved drug, naproxen could become a treatment against influenza relatively quickly, the researchers write. Its status as a non-steroidal anti-inflammatory drug (NSAID), which inhibits the COX-2 pathway, as well as an antiviral would boost its efficacy.

    http://www.asm.org/index.php/news-r...eliever-shows-anti-viral-activity-against-flu
     
  6. Snow Leopard

    Snow Leopard Hibernating

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    "Incredible" results. That are unpublished. *frustrating*
     
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  7. Jon_Tradicionali

    Jon_Tradicionali Alone & Wandering

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    Tomorrow.
     
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  8. lansbergen

    lansbergen Senior Member

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    Did not work for me but the immune modulator I use decreases it. Most likely at the gen level
     
  9. ukxmrv

    ukxmrv Senior Member

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    No for me. Ibuprofen is one of the painkillers I could tolerate after I had a RTA.

    However, it was not until I added Celebrex to the Valtrex I was already taking that the FM type pain I had developed after the accident finally began to go and I got more strength, mobility of muscles and joints and functioning.

    The later not to an enormous amount as I cannot afford to keep buying Valtrex and Celebrex (the NHS won't pay for them).
     
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  10. natasa778

    natasa778 Senior Member

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    Curcumin is a powerful cox-2 inhibitor, than again not sure if that effect holds in vivo ... Has anyone on here used enhansa or similar while on antivirals?
     
    Last edited: Nov 16, 2014
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  11. SDSue

    SDSue Southeast

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    Does anyone know how much Celebrex was used in this study?
     
  12. Jon_Tradicionali

    Jon_Tradicionali Alone & Wandering

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    200mg 2x/day
     
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  13. maryb

    maryb iherb code TAK122

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    Hasn't Celebrex got some potentially severe side effects, this put me off trying it? I can't tolerate ibuprofen but have massive inflammation problems.
     
  14. ukxmrv

    ukxmrv Senior Member

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    My GP told me that Celebrex was banned in the UK due to studies on the elderly and heart problems. He said he could lose his license if he prescribed it to me.

    The side effects I experienced were slight stomach problems when I first took it at 100mg and then when I increased to 200mg (once a day). It wasn't until I went to 200mg that I really did feel the benefits. By that time I was feeling the overall pain reduction so I didn't care about the stomach problems.

    I've never been beyond 200mg a day so no idea what the side effects would be like on double that dose.
     
    Last edited: Nov 16, 2014
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  15. SDSue

    SDSue Southeast

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    Looking back many years, when I was likely very early ME but didn't know it, I occasionally took Celebrex to deal with what I now know to be crashes. I learned that Celebrex made my crashes longer and much more severe. Perhaps without the antiviral it stirred up viruses???

    That said, I'm willing to try again, but this time in conjunction with an antiviral. Desperate times call for desperate measures!
     
  16. Gingergrrl

    Gingergrrl Senior Member

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    I had thought that Celebrex and Vioxx caused severe cardiac problems (in some patients, of course not in all!) and that was why Vioxx was pulled off the U.S. market? For me, it would be too big of a risk to try Celebrex and pain is not one of my major issues. Are there other meds that can take the place of Celebrex and combine with Famvir (which I am already taking?)
     
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  17. Sushi

    Sushi Senior Member Albuquerque

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    I believe Dr. Prigden has used other drugs than Celebrex (there are threads discussing his different combos) but as I remember they are all in the same class and have similar cardiac risks.

    Sushi
     
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  18. minkeygirl

    minkeygirl But I Look So Good.

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    @maryb I got really nauseated from Celebrex. I took mobic with acyclovir for months before I ever knew about Prigens protocol and it really didn't help much.

    I currently take 2 ibuprofen daily for sciatic pain with famvir and nothing.

    I do know some antiinflammatories have less of a risk than Celebrex. How much less I don't know. I don't think mobic is as bad.
     
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  19. JT1024

    JT1024 Senior Member

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    Just posted this on another thread:

    Results of Dr. Pridgen's Phase 2 clinical trials were revealed at today's American College of Rheumatology conference today in Boston. I was not in attendance but I was informed that it would be today. From the title below, it appears Famciclovir prevailed over other antivirals tested. Can't wait to hear more about this. Hopefully, a publication or presentation will be forthcoming.

    http://www.acrannualmeeting.org/wp-...4-ACR_ARHP-Annual-Meeting-Program-Book-v2.pdf

    A Combination of Celecoxib and Famciclovir Is Efficacious in the Treatment of Fibromyalgia: Results of a Phase IIa Randomized, Double-Blind, Placebo-Controlled Study
    William Pridgen1, Carol Duffy2, Judith Gendreau3 and R Michael Gendreau3, 1Innovative Med Concepts, Tuscaloosa, AL, 2University of Alabama, Tuscaloosa, AL, 3 Gendreau Consulting, LLC, Poway, CA
     
  20. Snow Leopard

    Snow Leopard Hibernating

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    I must say, I am a little alarmed that Pridgen in his patents for this treatment refer to it as a treatment for "functional somatic syndromes" (in the title of the patent).
     
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