What does Ampligen's effectiveness tell us in light of the latest research?

[jpcv]

Interesting links from another thread:

Lots of misinformation here. From the SEC filings and press releases:

Hemispherx did have manufacturing problems, they have now been solved. They have a primary and a secondary contract manufacturers and they are both manufacturing on an accelerated basis. They are located in Washington State and Southern California.

The price has recently gone up 167%

Ampligen is available in the U.S. - but only to existing AMP511 trial participants. No new patients, however Hemispherx continues to seek approval in the U.S.

The push seems to be to deliver to Europe through MyTomorrows which is based in Denmark and handles Early Access Programs. MyTomorrows has signed up/approved 50 pancreatic cancer patients to receive ampligen. There is an Early Access Program for CFS.

Argentina is the first country to approve Ampligen. However, much work to be done, from the most recent 10-K:

"There are a number of actions that must occur before we could be able to commence commercial sales in Argentina. Commercialization in Argentina will require, among other things, an appropriate reimbursement level, appropriate marketing strategies, completion of manufacturing preparations for launch (including possible requirements for approval of final manufacturing),....."

Hope that helps.

I have severe ME/CFS (required to participate in the trial). When I first started Ampligen, I was barely able to care for myself and had to hire drivers to get me to the infusion center. The effects were not immediate but after several months, I started getting better. I function at a much higher level on Ampligen. My labs improved too. Viral infections were under control. My natural killer cell test went from 5 to 70. Ampligen is a good drug in the hands of a bad pharma.
To answer your question, I am doing well for now.

 

[jpcv]

Ampligen in Europe:
https://globenewswire.com/news-rele...r-Sale-to-Early-Access-Program-in-Europe.html

 

[Jeremy C.]

In reading about Russian immune modulators, I came across a drug called ridostin. While I don't know how similar it is to rintatolimod or poly:IC chemically, it sounds like basically the same idea, sodium salts of dsRNA that will trigger interferon release. It's an injectable. Unfortunately I haven't come across any Russian online pharmacies that seem to carry it, though I haven't looked super hard.

It does sound similar! Does anyone know anything about this drug?

 

[Jesse2233]

I didn't know much about Ampligen beyond its Wikipedia article until this thread.
@Janet Dafoe (Rose49) Does Dr Davis know about it and might it be worth trying for Whitney?

Ron knows about it. He considers it an anti-viral and is concerned is that it could damage mitochondrial activity though I imagine he'll still test it on his assay if he can get access to it. It's mentioned in one of his and Naviaux's Q&A responses.

 

[Jesse2233]

In reading about Russian immune modulators, I came across a drug called ridostin. While I don't know how similar it is to rintatolimod or poly:IC chemically, it sounds like basically the same idea, sodium salts of dsRNA that will trigger interferon release. It's an injectable. Unfortunately I haven't come across any Russian online pharmacies that seem to carry it, though I haven't looked super hard.

Very interesting... @Hip you mentioned ridostin here. Do you know anything else about it?

 

[Alvin2]

Ron knows about it. He considers it an anti-viral and is concerned is that it could damage mitochondrial activity though I imagine he'll still test it on his assay if he can get access to it. It's mentioned in one of his and Naviaux's Q&A responses.

I see, i can very much understand such a concern, playing with fire can lead to a lot of collateral damage.

The way i see it in some cases it may be worth the risk if the alternative is worse, medication in general is a balancing act of beneficial vs side effects, for a headache one can simply say i don't like pain relievers but for treatable cancer the radiation and chemotherapy are hard on the body and cause damage but at a decent success rate its usually worth the risk/cost
I believe it was bisphonates that were approved because he reduction in osteoporosis outweighed the negative consequences of the drugs and nothing superior was available (at the time) though now we have Vitamin K2, i would personally remove their approval for osteoporosis

 

[Hip]

@Hip you mentioned ridostin here. Do you know anything else about it?

Never looked at it before, but I found this:

Ridostin. Manufacturer: “Vecterpharm”, Russia, “Diapharm”, Russia

Ridostin – mixture of double-stranded and single-stranded RNA sodium solts – potently induses interferone production and stimulates phagocytosis. Intraperithoneal injection of ridostin to mice induses intensive blood accumulation of interferon with peak at 8 hours, albeit interferone level was low in the respiratory tract and brain.

Contrastly, intranasal and aerogenic administration of ridostin induced interferon mainly in the upper respiratory tract and lung [68]. Intracerebral injection of ridostin induced accumulation of interferon in the brain and serum [69]. Combined treatment with killed vaccine and ridostine by the scheme of urgent prophylaxis (3 days before challenge) demonstrated 100% protection of Aujeszky’s disease infected minks, 75% protection of foot-and-moth infected pigs, and 50% protection of canine distemper infected dogs. Clinical symptoms of dogs developed canine dictemper was mild and delayed 23- 25 days post infection [70].

Source: Synthetic and Natural Immunomodulators Acting as Interferon Inducers.

Ridostin and Larifan belong to the category of dsRNA of natural origin (Fig. 2). As dsRNA are rather large molecules, IFN production induced by these compounds is carried out mostly by T lymphocytes with the help of additional cells.(23,24,39) Dendritic cells are presumed to have an inducer- presenting function in this case as it has been shown that den- dritic cells are presenters of antigen to Th cells. In addition, type alpha dendritic cell precursors show an ability to produce IFN-a/b in response to viruses.(41,42)

Source: Russian Experience in Screening, Analysis, and Clinical Application of Novel Interferon Inducers.

 

[Jesse2233]

Interesting stuff Hip, I wonder if it can be sourced

Intracerebral injection of ridostin induced accumulation of interferon in the brain and serum

who wants to volunteer and inject ridostin into their skull?

 

[Hip]

@Jesse2233
Some of these Russian interferon-inducers work on mice, but not on humans (yet they sell them for human use anyway!?!).

 

[Jesse2233]

@Jesse2233
Some of these Russian interferon-inducers work on mice, but not on humans (yet they sell them for human use anyway!?!).

Somehow I'm not surprised

 

[Jesse2233]

Another Ampligen account, former Lapp patient

Kelvin Lord

This is the story of me, doing something absolutely insane this past weekend. Something that was seminal to my progress, critical to my healing process, and something I felt I just had to do. After 10 long months being "stuck" in this place, last Thursday, I made a run for it. I escaped!

On a whim, after my Ampligen infusion last Thursday I went to the airport, bought a ticket for a 4 hour non-stop flight, and flew to Denver, Colorado! By myself! I then rented a car, drove an hour North, and spent the weekend in beautiful Ft. Collins, enjoying the crisp clean air underneath the majestic Rocky mountains.Yes, this means that I had enough energy and cognitive ability to follow a map to a place I'd never been, check into a hotel, and live at mile-high altitude. Yes, this means that the Ampligen is working better than advertised, and that my health is actually being restored. But it also meant something else of equal importance. Let me explain.


To say I have felt like a horse cooped up in a corral for the past 10 months would not be an exaggeration. As you know, when I moved here to begin the twice-weekly Ampligen infusion protocol, I could barely walk. Because my wife couldn't stay with me full time in this new town, we hired a cook and a maid to help me. That I needed this level of assistance when I started was not over-kill; I literally could not stand long enough to fry myself an egg ten months ago. Apart from going to the clinic every Monday and Thursday to get pricked by Gwen, for the first six months I was pretty much a one-trick pony. Week after week I would live on the couch, leaving my "pen" only to go to the clinic, and occasionally to church on Sunday. Having the helpers was awesome, but I still felt like I was in a modern prison.


As I've written about previously, after 6 months, something changed. The side effects started to abate. Energy slowly returned. I initiated a very slow program of exercise, walking and going to the gym near my apartment. I stopped the services of my cook, and began shopping and cooking for myself (bachelor-style). I let my maid go, and have lived without help for over 6 weeks now. In short, I started to experience a taste of "normal" life - a free life - for the first time in a very long time! But that small taste of freedom presented me with a problem.


You see, although I was actually starting to take baby steps toward living a healedlife, as clearly evidenced in my actions and in my body, my mind was still 'stuck' in protective mode; "sick" mode. Call it habit or fear or both, even though I could see myself making lots of progress, I was still scared.

• Scared that the healing would be short-lived;
• Scared that if I did just one morething, I would crash;
• Scared that after all this time, I wouldn't remember how to live!

That fear and self-protection habit was like a chain around my heart. If faith is the evidence of things not yet seen, then fear is the doubt of things already known. And I clearly was still acting like a sick person, imprisoned by my limitations. Even though the evidence said otherwise.


It came to a head last week when a social activity was presented to me and I turned it down immediately...out of habit!Despite all my test scores and charts* showing amazing progress, despite 6 full weeks of living independently and going to the gym everyday with energy, despite aching for friends and social interaction, when they asked if I could go, I said as I had so many times in the past, "no, I better not."


Ten seconds later it hit me. "What was I thinking????" I had gotten so good at living "within" my limitations, I couldn't break out of my limitations. I was an expert at living like a sick person! And it infuriated me.


Here I was at Week 40 on the Ampligen protocol, with 20 years of published research telling me that people were healed on Ampligen by Week 40, yet I still was on guard. Here I was with six full weeks of independent living, yet I was still playing it "safe." Like the men released from prison who still sleep on the floor after being released from incarceration, even though they now have a bed, I was trapped by the habits learned over years of sickness. Those habits protected me at the time, clearly. They probably kept me alive. But now, they were like quicksand, keeping me "stuck" in a place I should no longer be.

And his account of improved symptoms...

 

[Jesse2233]

Mary Schweitzer on Ampligen, current Peterson patient

As of May 2007, I have been on Ampligen for 5 years - or, another way to look at it, I have been on Ampligen for 8 years with the exception of the one year off in 2000-2001. Thus far there are no negative side effects, knock on wood. If there are long-term problems, I guess I will have to let you know!

My brain is back. I don't have trouble reading or writing, and I do not feel like a sick person 24/7 like I did when I first fell ill with M.E. - and then after the relapse. However, I doubt if I will ever be physically as strong as I was before. That's okay. I can do research and perhaps publish, and play with my new granddaughter. I have a voluntary relationship with a research institute at the University of Pennsylvania, where I can interact with other scholars and bright young graduate students when my health permits. It is a privilege and I enjoy the opportunity. I have a port-a-catheter in my upper left chest, so I no longer have to get stuck with needles twice a week (my veins just gave out after a while) - that makes this easier. It leaves my hands free to type (or knit or do needlepoint, for that matter).

All in all I am definitely better than I would have been without Ampligen, but I do not think I will ever be cured completely: I was too sick for too long for that to be possible. So, we do the best we can and are happy with what we have been able to recover. More than anything, I do want people to know that your brain can come back if given a chance. I also I believe that, had I had been diagnosed early in the disease and gone on Ampligen back then, I would be completely well now.

 

[Jesse2233]

From user OGrover on Reddit, former Enlander patient

I'll be happy to give you details. I feel on a mission to explain the drug because it has helped me, and I would hate to think someone else could be helped but doesn't try it out of lack of information or wrong information.

Free feel to ask me anything specific, in case my answer doesn't cover your question.

My first appointment, I was wheeled in on a wheelchair. Yesterday, I walked a whole block to get to the office with no problem. (I had to walk around barricades set up for the Pope's visit.) The biggest difference has been in increased cognition and deceased flu-like feelings. Stamina and strength are returning much more slowly.

The NK cells blood draws that the company does are kept blind, so I can't give you those results. I'm dying to know what they are myself. But I can give you subjective data:

• I would take prescription pain medication several times a month for headaches. I haven't taken any since July 20th. I still get a vague, foggy headache daily, but it's not even bad enough to take aspirin.
  
  
• I had stopped reading books because I couldn't concentrate. Now I'm on my third book since starting treatment. I use to have to break up movies into thirds. Now I can binge watch shows.
  
  
• My vital signs are more stable. Heart palpitations have decreased from several a day, to about one or two mild episodes. Used to get painful nerve tingling every day. I rarely feel them now and they are barely a ghost of what they were.
  
  
• My liver blood work is back to normal. Doctor said it's probably because it's not being taxed by the viruses as much as before.
  
  
• I was so weak, I couldn't open drink bottles. Now I can.
  
  
• I can stand a few seconds longer without my Orthostatic Intolerance kicking in. Couldn't lift my arms above my head. Now I do arm stretching every day. Couldn't stand at the sink to brush my teeth, now I do.
  
  
• Couldn't walk up the flight of stairs to my apartment without stopping to sit on the steps a few minutes before continuing. Now I can very slowly climb them without having to stop.
  
  
• I recover faster from PEM. What use to collapse me to bed for a couple days, now can resolve overnight.
  
  
• I'm taking less sleeping medication and sleeping better thru the night
  
  
• I stopped two prescriptions because the doctor and I thought I no longer needed them.
  

I could go on and on, but I'll spare you every detail. Am I well enough to return to work? Not even close, but I no longer suffer the multitude of symptoms this terrible disease inflicts on us.

As I said before, ask me anything about my illness and Ampligen.

 

[Gingergrrl]

@Jesse2233 Are you leaning toward trying to get Ampligen now as your main treatment vs. Plasmapheresis or Rituximab? I know you are investigating all options and probably still awaiting many test results but was just curious.

 

[Jesse2233]

Dr Paul Cheney on Ampligen:

Jeeney: My question today is about ampligen. I’ve been hearing so many mixed reviews. After you had your study and the people stopped taking the ampligen, what was that result?

Dr. Cheney: Well, there are several things I think that are important to note about ampligen. First, of all, there’s no doubt in my mind as I’ve seen it in clinical practice that this drug is bioactive in this syndrome. That is it can help people sometimes substantially. However, it does not help everyone. And it may be that the reason–there may be a couple of different reasons–one reason may be that no everyone has activation of this RNase L pathway which ampligen appears to be very potent at regulating, in CFIDS at least, downregulating. If that pathway is not activated, then ampligen may not be very rational or even effective. Ampligen also has potent antiviral properties as well and I think some of these patients may not have a significant viral activation state which may be another reason why it doesn’t work in everyone. The other parallel issue for ampligen is that it appears that the longer that you take it, if you are responding to it, the better the outcome and in the initial study in 1991-92 we essentially only treated for 6 months in most cases, a year at most and that may have been a relative under treatment and so when you’re under treated with ampligen, even if you’re a responder you tend to degrade very quickly when you stop and conversely, when the drug is treated for longer periods of time a better clinical therapeutic plateau is reached, there appears to be some stability at maintaining a plateau once the drug is stopped. So, I think it’s kind of uncertain in my own mind exactly what will happen when you stop this drug. My sense is that if it’s stopped prematurely, one will end up pretty much back where you were. If it’s maintained over a longer period of time, there’s a much better chance of stability. If you are a responder, the chances of a response, all comers, appears to be 2 chances in 3 and that might be raised a little bit if one targets a subset of patients, specifically ones that are within the first 5 years of their illness who have abrupt onset and who may have activation of this RNase L pathway

 

[Jesse2233]

@Jesse2233 Are you leaning toward trying to get Ampligen now as your main treatment vs. Plasmapheresis or Rituximab? I know you are investigating all options and probably still awaiting many test results but was just curious.

I tried to get Ampligen back in February but at the time it seems almost impossible. I spoke to the offices / research departments of Drs Peterson, Lapp, Klimas, Podell, and directly to Drs Bateman and Enlander. Dr Bateman even tried to contact Hemispherx to get me in (God bless that woman) but they refused. But I now have an in with her should the 511 program start accepting new patients.

I reached out to MyTomorrows and one of their directors tried to find a doctor in Europe to do it and couldn't. I then tried having my friend in Italy who speaks four different languages call all the top CFS/ME doctors in Europe and they refused.

I contacted several officials at Hemispherx directly as well, and they said not at this time.

Finally I reached out to a random rheumatologist in Argentina who very kindly researched the situation (he hadn't even heard of CFS!) and told me it's not yet available there.

So I did all I could for the time being. It's #1 on my list and I will leap to get it if any of these avenues open up. For now I'd like to encourage demand on the patient level (part of the purpose of this post) as well as better understand how it works so that alternatives with similar mechanisms of action can be found. But treatment wise at the moment, I'm focused on IVIG / plasmapheresis and possibly Rituximab

Edit: also reached out to Kolibri in Norway in the hopes that if they were forward thinking enough to use Rituximab, they'd consider Ampligen. Unfortunately not

 

[Gingergrrl]

So I did all I could for the time being.

That's for sure and you have done more in four months than what has taken me four years like I said before.

It's #1 on my list and I will leap to get it if any of these avenues open up.

I did not realize that, thanks for clarifying. I don't understand the mechanism of Ampligen well enough to know if it would apply to my case (aside from the fact it is not available).

But treatment wise at the moment, I'm focused on IVIG / plasmapheresis and possibly Rituximab

That's what I thought. It seems that Rituximab can attack EBV that is hidden in the B-Cells in addition to the known autoimmune mechanism. I had assumed Ampligen was more similar to an anti-viral like Valcyte or Vistide but maybe I am totally wrong?

 

[Jesse2233]

That's what I thought. It seems that Rituximab can attack EBV that is hidden in the B-Cells in addition to the known autoimmune mechanism. I had assumed Ampligen was more similar to an anti-viral like Valcyte or Vistide but maybe I am totally wrong?

That's the million dollar question. Maybe only Dr William Carter knows the answer

 

[Gingergrrl]

That's the million dollar question. Maybe only Dr William Carter knows the answer

I just Googled Dr. William Carter but got a million hits that I am sure are irrelevant. Who is he?

 

[Jesse2233]

@Gingergrrl

He's the founder of Hemispherx, and one of the original researchers who developed the drug

Truth be told he may not even fully understand its implications for autoimmunity