I'm not sure if I understand your statement can you clarify please. These are patients who have had an XMRV + test who were then enrolled and given Ampligen or Placebo for 40 weeks (9 months). The patients were then tested to see if their ablity to handle exercise had increased. XMRV+ patients showed a 25% improvement in ability to handle activity. The rest of it I'm a little shaky on untill I see the actual study. Which we should see since it was posted at the XMRV conference.
Actually, I was in the phase III trial (AMP-516), which was done 2003-2005 or so. They took all the data that they had gathered from those patients back then (treadmill tests), tested our banked blood samples for XMRV after the Science paper was announced last October, and then compared the two. They haven't done new Ampligen trials since then. They continued the AMP-511 (the one where you have to pay for the drug yourself) but it was/is very few patients and the only site still doing it is Reno. (Not double-blind, placebo controlled). At least that's how I understand it. I'll try to get clarification this Saturday at the OFFER conference.
Aha! (grins) That's great information LaurelW. Thank you. So they did it backwards. (head shake) That's why I like to see the actual data instead of someone elses' interpretation of it. Did you get to take the drug? Did you do better?
If Ampligen is a synthetic interferon why haven't they tried just regular interferon to boost NK cell production. I know they give interferon to MS patients and it helps some. But I've never heard of a interferon trial, ya know?
Yes, they indeed did it backwards. I also wonder how they stored the blood. Seems like I gave vials and vials over a year and a half period. And to answer your question, George, I did get dramatically better. I lucked out and got the drug for the first 40 weeks, which were half drug/half placebo. After that they gave us all the drug for 6 months. The longer I was on it, the better I felt. A lot of people relapse soon after they go off the drug, but I didn't relapse for 4.5 years of nonstop college, foreign travel, and a couple deaths in the family. (Yes, if I knew then what I know now, I would have built in much more in the way of time off).
I'm XMRV+, so of course I think there's a correlation. I'm wondering when Hemispherx is going to do new trials, and if they will accept people that they already used, or if they want all new people. I'm already lining up at the door.:wheelchair:
Thanks LaurelW for providing a more detailed explanation. Hemispherx has said all along that they will do another Phase III - I think things are unfolding so quickly that they are still formulating. Hopefully they can get it together this fall. The data they gave on the 8th looks good, but the data they shared is incomplete and is somewhat confusing. They are presenting at the Rodman and Renshaw investor conference next week, so maybe we'll learn more.
Hemispherx has a webcast available that everyone can listen to to find out more about the current status of Ampligen if youre interested. It can be found at...http://www.wsw.com/webcast/rrshq18/heb/ or by going to there web-site.
Yes my understanding is they did retrospective analysis on past clinical trial patients and measured their exercise treadmill tolerance. Of the CFS patients in the study...the XMRV + patients had improved their performance level by greater than 25% when compared to CFS patients who did not have XMRV...which is a great sign as it shows Ampligen is improving patients who are positive with XMRV. If you look at the slide in their presentation you can see there graph is showing XMRV + patients actually had almost doubled (97%) improvement in activity level versus the non XMRV CFS patients who only improved about 61% in energy levels. I realize they are doing it backwards, however understand they have been fighting hard with a great deal of passion trying to get a drug approved for CFS based on the science available to them. They have been working with Wittmore Pederson and are play a large role in why XMRV was found in the first place. A rare few companies have had more challenges in seeking regulatory approval than they and their work has been an integral part of CFS development the past decade. CFS patients are not the only ones who have had to listen to CFS calling it a mental disorder and getting little funding or attention from government. This company has been beaten and dragged through the mud and withstood shameful attempts at short selling their stock and countless acts of media bias...yes they are still standing and moving forward. (Thanks Dr. Carter when Ampligen gets approved)
As for Drug approval please note that Hemispherx has Orphan drug status to treat CFS in the US and I believe have 5 of the 7 years term remaining which means Ampligen actually has the best shot at approval of all drugs out there, if not the only shot. It has also been tested with numerous aids drugs but could not quite find any approval for Aids as it lacks the antiviral aspect, despite improving immunity immensely. What we are learning is that XMRV may exist in many but may only become a factor in patients that develop problems with their immunity, which occurs when they do not develop natural antibodies to fight the virus thus allowing it to spread and gain a hold.
Hemispherx will meet with the FDA for one last phase 3 trial of 300 patients in the near future as they were told late last year. However they are sponging up as much XMRV info as possible to make sure they incorporate all necessary factors into the next trial. This drug has been proven to be effective and they have data on over 600 patient years combined of analysis and over 60,000 does tested. Patients improved but the FDA could not approve without knowing why they were improving as measurements were difficult to test for, thus the treadmill tolerance test. Now they can measure the XMRV virus and antibody responses which will boost their approval chances tremendously. Only 70% or so of patients were improving on the drug, and many had negative reactions which were deemed to be "relatively well tolerated, however the risk factor was still there. However it's a new ball game with XMRV identified. (Oh and to answer a previous question, Grand Slam is home run with bases loaded best hit possible in a ballgame, Id like to hear bottom of the 9th though)
Now they will be able to adjust doses to appropriate levels based on the severity of the virus which will allow for less negative reactions. They may however only be able to treat XMRV + patients moving forward but at the same time they will probably be able to tell if the XMRV- patients were the ones bringing down efficacy levels in their past trials. Some patients are known to relapse after stopping the drug...but again now that XMRV exists we can now assume their bodies simply could not adjust for the stored XMRV within their organs getting another shot at expansion when antibodies begin to decrease again. There is no doubt CFS patients all seem to have the common factor of a weak immune system. Ampligen may never be able to fix the immune system so that people can heal themselves and live normally, but it is proven to treat and keep the virus at bay and allow for some normalcy. The good news is Ampligen has been tested as an adjuvant with many Aids drugs including AZT...thus I see treatment coming in the next year or so through a phase 4 trial followed by development of antivirals in the next few years. There are rumors there could be more govt help to help bring down costs for compassionate care use but only time will tell.
Broad based immunotherapy drugs if proven safe will be the wave of the future...Why, because "An ounce of prevention is worth a pound of Cure". If an original sickness such as Mono or Mold or a bad bout of the flu... can stop the immune system from functioning and cause people to get sick for months/years on end than we need to start looking at prevention right from the get go. Thus why Echinacea and or Cold FX/liquids/Vit C may not be a bad idea to consider when first getting sick. Woman seem to be affected more...from what I understand it has to do with the way woman handle stress. The adrenal glands release cortisone which helps reduce stress and bring back homeostasis but somehow the female cycle may be releasing too much cortisone sometime each month and messing up the entire system. And many of these woman have bad eating habits and exercise too little and eat to few expensive fruits and vegetables and already have weak immune systems, and then a sickness pushes them over the top. Men likely get CFS because of the same reasons, but men typically have more muscle and stay in better shape as lets face it, we do not have babies and our bodies are not built to have enough for twoand men are generally simpler in terms of less stress because we have been the provider for yearsonly since woman started working have they had to take on the same kind of stress as men, Im just not sure if the biology was intended for woman to play that same role is all? CFS is growing and I predict initial #'s are still underestimated, equal rights for all means we have more woman working these days and we all know a dollar these days doesnt go as far as it used to so more and more people are working and running on less sleep and have more stress in their lives and are more susceptible getting sick. Who can afford vitamin C these days, its expensive and does not last as long, thus why we all clog our arteries with sodium because we need the food in our pantries to last that much longer as we have turned into a convenience society.
I have to admit the CDC/FDA/NIH should have found the virus long ago, however i can not blame them for the there past recommendations and prior actions based on the info they had to work with. I do expect them to delay this a while longer and pretend to run more vital confirmatory tests so they can get their action plan in place. They know darn well XMRV is a serious threat, but why admit it now and face the music with their pants down when they can use the excuse of XMRV being "difficult to test for" as so many other labs are coming up with negative tests and these groups are giving them the time of day to present when we all know if they do not follow the exact same procedure they will find nothing. Sitting and giving these guys face time simply allows the govt more time as the picture paints itself from there. They have the perfect excuse to sit on it and find a way to save their careers right now so why not use it. The positive is that they will now be extra motivated to go above and beyond so they come out looking good to their bosss.
Ampligen should be approved within the next year. Sorry I should clarrify in that i expect it to be approved for XMRV + CFS patients only. There is too much passion in the CFS underworld to stop it now. Dr. Carter from Hemispherx has the same passion and they have been working with the passionate Whittemore Pederson group too. And I love the work that firecracker Dr. Judy Mikovits brings, kind of reminds me of Erin Brockovich. Sure would make a good movie in a decade or so eh!
I exercised like I was training for the fricking olympics when i got afflicted for the fatal blow, but truth be told I could have ate better back then, it was the 80s and all about low fat high carb, not the most nutritious in retrospect.
I think I eat great now compared to most of the planet but still getting ostepenia........
I am XMRV+ and tried ampligen in 1999/2000. It was very tough. Until this day I feel a lot stronger than before the treatement. That is my only improvement after 9 months of treatment. And oh yeh I gained weight which was great but that lasted for about 5yrs, and then I started to lose weight again.
I think its clear that you work for hemispherix. You obviously have a lot of inside information and this is your first post. When I first started reading your post I was intrigued by all the info but wish you were up front about your affiliation. We're not a bunch of dopes. However, the more I read the more appalled I was. Women get sick more often because men handle stress better because they have been in the provider role? Seriously? If that's the 'science' coming out of hemispherix I have little faith in anything you do.
You should declare your affiliation when you come posting here. If you're not affiliated with that company, than please tell us who you are and why you're posting this. And please show some prove that Ampligen will be approved next year.
Besides that, I like your post!
I know for many it isn't fun to hear women are more suspectible to ME/CFS (especially when heard in a psychological context-----> stress) but that is a scientific proven fact. Mikovits said hormonal effects are indeed an important factor in HGRVs, so that could be a plausible explanation why more women than men have ME/CFS. I do however agree that it is just speculation at this point.
Nothing personal, but we all want to have the scientific community be open-minded, but I think many patients have as much as a tunnel-vision as the people they accuse of being narrow-minded.
It is sort of stunning, reading that Lancet editorial and this how deeply internalized in the cultures sexism still is and a sort of blame-the-patient attitude especially when the patient is annoying because they won't go away but they sort of look alright