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!