Ampligen Takes Big Step Forward - Becomes First Drug Approved Anywhere For Chronic Fatigue Syndrome

Discussion in 'Antivirals and Immune Health' started by Cort, Aug 25, 2016.

  1. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    Ampligen became the first drug approved for chronic fatigue syndrome (ME/CFS) anywhere in the world this week when ANMAT, the Argentine FDA, approved the drug for use in people with severe ME/CFS. Why should we get excited about Ampligen's approval in Argentina? Because Argentina has a modern medical system which includes having a rigorous drug approval process. Hopefully this will be a harbinger of things to come for Ampligen.

    Argentina was the first Latin American country Hemispherx Biopharma (HB) - the maker of the drug - tried to get Ampligen approval in. The process, which took four years, began when HB teamed up with GP Pharm, an Argentine pharmaceutical company. GP Pharm used the same studies to shepherd the approval through ANMAT, the Argentine form of the FDA, that HB used in its FDA application for Ampligen two years ago.

    Ampligen was approved for use in people with "severe ME/CFS" - a designation that was based on the type of ME/CFS patients that took part in the company's original U.S. studies. A person with severe ME/CFS in Argentina needs to meet the new IOM and the (old) Holmes criteria, and have a Karnovsky score between 40 and 60 in order to get access to the drug.
    • 40: Disabled; requires special care and assistance.
    • 50: Requires considerable assistance and frequent medical care.
    • 60: Requires occasional assistance, but is able to care for most of his personal needs.
    Hemispherx believes that at least 100,000 and perhaps as many as 500,000 patients in the 42 million person country will meet the criteria.

    Equel's has been making the rounds of media outlets to discuss Ampligen. A financial analyst with Crystal Research agreed in an interview at Small Cap Nation - a financial media outlet focused on small companies - that the potential for Ampligen in the ME/CFS market alone was huge. With Ampligen the sole drug even being considered at this point for ME/CFS it would have the market to itself. He called the Argentine approval "very significant" and put the potential valuation of the drug in the multi-billion dollar range.

    He also agreed the Argentine approval will make getting approval elsewhere easier.

    The FDA Question

    I talked with Nancy McGrory at Hemispherx about the recent approval. She believes the approval could help HB in other countries with similar regulatory drug processes. The fact that Ampligen passed muster in a country with a modern medical system with a rigorous drug approval process will likely, McGrory thought, prompt other countries to take a much closer look at the drug.

    Ten years ago, she noted, most pharmaceutical drug companies concentrated on getting drug approval at the FDA first in the belief that making it through the FDA's notoriously tough regulatory process would give other countries confidence that the drug was safe and effective. The FDA - which is focused first on protecting the public health - has proved so risk averse lately, though, that some drug companies are choosing to get drug approval outside the U.S. first.

    That brought up the question, though, what's going with FDA approval for Ampligen? When I asked McGrory about the reception Ampligen was getting at the FDA these days, she sounded hopeful. She said she believed that the work of patients, advocates and ME/CFS experts to educate the FDA about ME/CFS had paid off. The FDA Workshop and other meetings, she believed, really got the message across about how serious disease is, and that produced a sea-change in the agencies attitude towards ME/CFS. The FDA she thought, would like very much to approve a drug for this illness.

    Thomas Equels, HB's new President has made Ampligen approval the companies top priority and has stated that he will to do whatever is necessary to get it done. McGrory said HB officials have meet with the FDA and the NIH several times, and will soon meet to finalize the protocol for what will hopefully be the final phase III study on ME/CFS.

    The FDA wants, and is going to get a several hundred person trial. Equel's job now is to find partners to fund it. The companies new stance - that it’s committed to reach out and either license its technology or find a major pharmaceutical company or investor to assist it - is a distinct change of pace at HB.

    In another hopeful note, Hemispherx reported it's at long last identified a subset of high responders to Ampligen and will present a paper to that effect at the IACFS/ME conference in October. Finding high responders to Ampligen would, of course, greatly help HB be successful in a phase III trial.
    When asked in an extensive interview with Wall Street Transcript about what a potential investor should know about Ampligen Equels said:

    Last edited: Aug 26, 2016
  2. Who Me?

    Who Me? Well-Known Member

    And for people who aren't quite so severe. I'm not sure where I'd fit on that scale. 60+?

    This should have happened 20 + years ago after the first clinical trials
    Last edited: Aug 26, 2016
  3. jsuzor

    jsuzor Member

    I was in a study for Ampligen in 2000/2001. I'm pretty certain that I received the drug because I had a mild allergic reaction, so I was told to take Benadryl. At the end if the study, we all received the drug, and as far as I know.. none of us experienced noticeable improvements. I can't speak for everyone, but Hemispherix never kept tabs on me after the study.

    The study was with an Immunoligist in Davie FL. One of the guys in the study had family with stocks in Hemispherix. He found out that Hemispherix was trying to get Ampligen approved for HIV, and he dropped out of the study. His family lost money too (According to him). That was during the initial phase when some were placebos.

    There is a lot of hype around that drug, but I believe it is propoganda. I don't trust Pharmaceutical companies. I did find out that I have the RNaseL problem, and still have a copy of the lab work on that.

    Supposedly, Ampligen improves that RNaseL dysfuntion. At that time our blood work was sent to Belgium for that test. There is a lab in the U.S. doing it now called Red Labs. Now if my RNaseL improved I would have heard about it. And Hemispherix would have kept in touch with me.

    If anyone in this group has been in a study for the drug and improved I would be interested in hearing about it. And I would hope that it's not some phony person, but someone who has a history in this group like I do.
    Last edited by a moderator: Aug 26, 2016
    ankaa, Merida, Sue Stevenson and 3 others like this.
  4. rebar

    rebar Active Member

    In conversation with my ME/CFS doctor, who is a part of the Lipkin study, there are now known markers for who will respond, "very accurate", she stated
    when I ask how accurate she repeated "very". She also mentioned the success in Argentina but also said it still is a distant option here in the states.
    jsuzor, IrisRV, Veet and 1 other person like this.
  5. 460inparadise

    460inparadise Member

    I'd like to know how much it will cost in Argentina.
  6. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    We don't know yet. They have a social security system in which the government reimburses the patients for the cost I believe Hemispherx has to work with the govt the reimbursement amounts. I have no idea how much it will cost outside of the system. I imagine that those details will get worked out over the next six months or so. GP Pharma I think it is would probably be the one to contact.
    Merida likes this.
  7. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    An oral version would make it so much easier and I assume more affordable. If they can get things going and get a partner and some money I imagine that would be something they would work on.
  8. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    When I talked to Nancy she said the Dr. Carter, the former CEO - who was very good on the scientific side - really wasn't that interested in partnering with anyone. He held everything close. (I would note though that the agreement with GP Pharma was made under his watch.) Now HB has decided they must reach out and partner. With new management in place hopefully they'll be viewed as a good opportunity to partner with and things will finally move along.

    They're going to have to come up with a lot of money for that several hundred person study. However, with Ampligen the only drug in the ME/CFS pipeline - they would have the market to themselves. They have Orphan drug status for Ampligen in the US for six or seven years - meaning, I think, that they have six or seven years to market the drug themselves before a generic can be made.

    The clock is ticking!
    Merida likes this.
  9. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    I know of four people who have improved. Anita Patton is one - her recovery story is in the recovery stories section. I've met her several times. Bob Miller was still pretty impaired but he was able to function and travel and without it he was basically bedridden. He was on it for years and may still be on it. He tried to go off and relapsed after a year or two. Mary Schweitzer's case is well dooumented as well. She's given testimony at many CFSAC meetings. I saw her off Ampligen - she was in a wheelchair and could hardly talk and then there's Kelvin Lord - he published a long and really hilarious series of blogs of his experiences when I was Phoenix Rising...He was desperate when he went on it and was functioning and working again but certainly not cured on the drug.

    I also know of people who got absolutely no help at all on the drug.

    There's no doubt Hemispherx has a really tattered past and there's a blog on that in the Resource section below. I hope that is all behind them.
    Last edited: Aug 26, 2016
  10. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    I wouldn't fit the parameters either. They were based on the really severely ill patients in those studies. They charted hospitalization rates during one of the studies - it was incredible how many people ended up in the hospital during the study - not because of Ampligen - but because they were so darn sick. It was jaw droppingly high. (Ampligen's reduction of the hospitalization rates was one of the arguments for the drugs).
    Merida and Veet like this.
  11. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    Whoa! :wacky:

    Now that's exciting...

    Are you comfortable saying who your doctor is?
    PamJ likes this.
  12. Gijs

    Gijs Active Member

    At this point i really don't believe in this product for CFS/ME/POTS. Also the price for this drug is 4 times higher then before. ! I think, these people like to make a lot of money with this drug.
  13. Equipoise

    Equipoise Member

    I've been on Amplign twice, during the 2002-2003 study, and again from 2011 till the present. After the first study, I was relatively well for five years after going off the drug. This go-round, I've gone from a 20 on the Karnofsky scale to a 60. It is an effective drug for some people, so it would be great if there was a biomarker to tell who it would help.

    Hopefully when it gets approved the insurance companies will cover most or all of it.
    Last edited: Aug 29, 2016
    Merida, GinnyMH, jsuzor and 5 others like this.
  14. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    Twenty to 60 is a big jump! My guess is that most people who improve do just that - they improve and are not recovered. Anita is probably an exception but there are others out there like her.

    I hope they get that several 100 person study going - the results will be fascinating..
    PamJ likes this.
  15. Anita Patton

    Anita Patton New Member

  16. Anita Patton

    Anita Patton New Member

    Ok so this is Anita and I just wanted to jump in and say that the news of approval in Argentina is very good for us ALL of us because it is the first drug approved for ME/CFS. The science and research has progressed immensely in the 19 years that I have taken Ampligen. It has significantly helped me!

    My labs have gone back to normal and I'm able to do much more than before, meaning upright and off the sofa v bedridden with fevers and swollen glands. it is an immune modulator and makes your body produce interferon and eradicates the reactivated viruses in the blood and spinal fluid. and acts as a high powered anti-inflammatory agent so the brain swelling of encephalitis has gone down - meaning I also have less headaches as well as more energy and ability to fight infection. talk about risk v. Benefit!

    I have no side affects but highly improved health. I wish for every patient to get medicine!

    It hurts my heart to see patients suffering when there is a medicine out there that can help a certain subset. Slso, this approval makes it easier for other new drugs to be invented that might help even more because the press alone has inspired more scientists to come on board and search for answers.
    Last edited by a moderator: Aug 26, 2016
    Merida, GinnyMH, jsuzor and 5 others like this.
  17. Who Me?

    Who Me? Well-Known Member

    Hi @Anita Patton. could you please go back and add some paragraphs to your post. I am unable to read big huge chunks of text. Thank you.
  18. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    Got it - paragraphs added :)
    Who Me? likes this.
  19. PamJ

    PamJ Active Member

    I thought I had a moderate case of CFS/ME, but it looks like I'm at about 60 on the karnovsky scale. I can't wait to hear who they think will have the most benefit from Ampligen!
  20. Sue Stevenson

    Sue Stevenson Active Member

    Does 60 mean I'm able to feed and water and clothe myself except for the days I can't get off the couch all day and still don't feel up to cooking? I don't know.

    I do know that I can do more than some but I can't maintain much and my life is curtailed pretty significantly.

    Welcome, @Anita Patton. Reading your post gave me a thirst for Ampligen. Even though I am not sure I'd meet the criteria, my life sure would look different if it worked for me the way it did with you. Guess I will stick with cat's claw and NSAIDs for now
    Merida, jsuzor, Lissa and 1 other person like this.