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Ampligen - Hemispherx Biopharma re ME/CFS

Discussion in 'BioMedical ME/CFS News' started by Sly Saint, Nov 24, 2017.

  1. Sly Saint

    Sly Saint Senior Member (Voting Rights)

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    "Hemispherx to Present at the 30th Annual ROTH Conference

    ORLANDO, Fla., March 05, 2018 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc.(NYSE American:HEB), focused on pharmaceutical research, announced today that it will be presenting at the 30th Annual ROTH Conference on Monday, March 12th at 5:30PM PT in Green - Salon 3 (the time may be subject to changes depending on the conference organizers) at the Ritz Carlton in Dana Point, California.

    The Company webcast can be found at http://wsw.com/webcast/roth32/heb/ following the presentation on March 12th.

    Thomas K. Equels, M.S. J.D., Chief Executive Officer of Hemispherx Biopharma, will be presenting as well as meeting with investors one-on-one.

    Mr. Equels' presentation will focus on ME/CFS (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome), immuno-oncology, and immune system amplification for enhanced viral vaccines."

    https://www.nasdaq.com/press-releas...he-30th-annual-roth-conference-20180305-00595
     
  2. jaded

    jaded Established Member (Voting Rights)

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    Andy likes this.
  3. jaded

    jaded Established Member (Voting Rights)

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    Unfortunately it won't let me download the slides. To gain access all you need to do is add your name and email address and I put company name as "patient".

    To be honest the lecture wasn't that informative and not all specific to ME (discussing other clinical uses as well). The main points were (most of which is known already):

    - It is well-tolerated and has a good safety profile with over 100,000 IV doses given
    - It has broad spectrum antiviral activity by acting as a TLR3 agonist and is immunomodulatory
    - Ampligen enjoys orphan drug status for ME
    - For ME, an NDA filed with the FDA but a confirmatory phase 3 trial is required in the US before approval. They're in the process of designing a phase 3 trial and negotiating the terms of that trial.
    - It's approved in Argentina for ME. The first drug approved for ME anywhere in the world. Although it's not commercially available quite yet.
     
    Inara, ScottTriGuy, MEMarge and 4 others like this.
  4. Sly Saint

    Sly Saint Senior Member (Voting Rights)

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    Hemispherx BioPharma : Releases First 8,500 Vial Lot of Ampligen to Supply Expanded Access Programs in the United States, Europe and Canada

    "The first commercial-sized lot of Ampligen, which completed cGMP manufacturing on April 4, 2018, has passed all required testing for regulatory release for human use. These 8,500 vials are earmarked for distribution to United States based Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) expanded access programs in Nevada and North Carolina, United States clinical trials in immuno-oncology, European expanded access programs and for certain testing and validation required for commercial launch in Argentina.

    The company also reported that its cGMP contract manufacturer successfully filled and finished a second commercial-size batch production run of roughly 8,000 vials. This is the second such successful commercial sized production run in the last two months. This second commercial sized lot is currently undergoing regulatory testing for human use, a roughly two-month process."

    http://www.4-traders.com/HEMISPHERX...-to-Supply-Expanded-Access-Programs-26795848/
     
    Binkie4, Inara, ScottTriGuy and 5 others like this.
  5. lansbergen

    lansbergen Senior Member (Voting Rights)

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    If they mean cyclic guanosine monophosphate it may help.

    The immune modulator levamisole I use increases cGMP.
     
  6. sjJohnny

    sjJohnny Established Member (Voting Rights)

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    cGMP = Current Good Manufacturing Practices
     
    ScottTriGuy likes this.
  7. sjJohnny

    sjJohnny Established Member (Voting Rights)

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    Hemispherx Opens FDA-Approved Reimbursement Based Expanded Access Treatment Program for ME/CFS to New Enrollees at Approved Clinical Sites in Nevada and North Carolina

    "We view the compassionate care program as just a band aid for a much larger problem. We estimate over one hundred thousand people are now fully disabled in the United States due to ME/CFS. This incapacitating unmet medical need should be aggressively addressed by providing therapeutic options, just as the FDA did when it successfully addressed the AIDS crisis years ago," said Thomas K. Equels, Chief Executive Officer of Hemispherx.

    http://ir.hemispherx.net/profiles/i...ryID=87984&BzID=2265&g=980&Nav=0&LangID=1&s=0
     
  8. Jaybee00

    Jaybee00 Senior Member (Voting Rights)

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    What's the update on Ampligen? Are people getting Ampligen in Nevada and North Carolina? How does one get Ampligen in Nevada or North Carolina? Is it working? Can a person get Ampligen in Argentina or Europe?

    Thanks
     
  9. sjJohnny

    sjJohnny Established Member (Voting Rights)

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    From today's PR:

    In parallel, we continue to pursue Ampligen for the treatment of severe myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Ampligen is approved for this indication in Argentina (the first and only meaningful therapy approved anywhere in the world for ME/CFS) and is available through an U.S. Food and Drug Administration (FDA) authorized expanded access program (EAP), AMP-511, a program where the FDA has approved the reimbursement rate of $200 per vial for the direct costs and where we are expanding participation at clinics in Nevada and North Carolina.

    Today's PR was mostly focused on their oncology program... which is their best shot at becoming a viable company. Treatment in Argentina begins at the end of this year - they expect 3 patients by years end. re: Europe, you need to check with MyTomorrows to be sure, but I think ampligen is only available to pancreatic cancer patients at this time.
     
    andypants and Hutan like this.
  10. Alvin

    Alvin Senior Member (Voting Rights)

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    3 patients only?
     
  11. Sly Saint

    Sly Saint Senior Member (Voting Rights)

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    Dec. 17, 2018 (GLOBE NEWSWIRE) --

    Hemispherx Biopharma, Inc. (NYSE American: HEB), an immuno-pharma R&D and emerging commercial growth company focused on unmet medical needs in immunology, recently met with clinical patients at Hunter-Hopkins Center in Charlotte, N.C. undergoing treatment for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

    https://globenewswire.com/news-rele...nded-Access-Program-in-the-United-States.html
     
  12. Trish

    Trish Moderator Staff Member

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    So the use by Dr Lapp in North Carolina is expanding with more drug available, and there are plans for use in Europe. What is not clear from this press release is whether this is being done under clinical trial conditions. It seems not, as it says:
    Does this mean that there have been sufficient clinical trials to demonstrate efficacy?
     
  13. Seven

    Seven Senior Member (Voting Rights)

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    Can somebody tell me if this is still by IV? I would love to do it but I cannot TrackR twice a week 3h to go get it. Does anybody know what the current protocol is?
     
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  14. sjJohnny

    sjJohnny Established Member (Voting Rights)

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    Yes, by IV. It’s a large molecule drug, so it’s doubtful that will ever change.
     
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  15. sjJohnny

    sjJohnny Established Member (Voting Rights)

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    That AMP-511 is a compassionate treatment protocol that’s been available for 20 years. FDA wants one more large trial. Argentina has approved.
     
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  16. Jaybee00

    Jaybee00 Senior Member (Voting Rights)

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    And do we know of any physicians/clinics in Argentina that are administering Ampligen?
     
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  17. sjJohnny

    sjJohnny Established Member (Voting Rights)

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    Contact hemispherx to find out the status.... GP-Pharm is handling Argentina. http://gp-pharm.com/
     
  18. sjJohnny

    sjJohnny Established Member (Voting Rights)

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    Hemispherx Biopharma Inc. Announces First Large Ampligen Shipment to a Clinical Site for Use in U.S. Expanded Access Program

    http://ir.hemispherx.net/profiles/i...9410&GoTopage=1&Category=2178&BzID=2265&G=980

    Hemispherx recently announced the expansion of the protocol, allowing new enrollees, who would not be eligible to participate in a future confirmatory trial. Hemispherx continues to believe that this study does not and will not interfere with any future studies planned to obtain marketing approval. Any future confirmatory clinical trial is not expected to include previously-treated patients such as those currently enrolled in the AMP-511 protocol, and we do not believe that recruitment of new patients into any future studies will be impaired by additional enrollment in the treatment protocol. Expansion was possible because this year Hemispherx successfully produced two commercial-sized lots of Ampligen, which were filled and finished into approximately 16,000 vials. Both lots have passed all necessary release testing and are now available for distribution.
     
    Little Bluestem likes this.
  19. Seven

    Seven Senior Member (Voting Rights)

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    So unless everybody moves close to center we will not be Abel to access :( since they make it mandatory to be done on the centers 3 or 2 times a week for 3h!!! That is a part time job.
     
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  20. sjJohnny

    sjJohnny Established Member (Voting Rights)

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    Indeed. That's always been the problem with the amp-511. Few can afford it.
     
    Little Bluestem likes this.

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