Ampligen success rate?

[LaurelW]

Thanks for the info, JohnnyD. I'll check into it.

Riley, that's a tough call. I can see why you need as much info as possible.

 

[SpecialK82]

HEB filed the formal protocols in late November. Cater said in December that he believed by February or March they would have enough data from the retrospective (65-80%) to meet with the FDA. In a call and in an interview he is states 3rd quarter NDA submission.

This is puzzling - how would they file in 3rd quarter (2011 I assume) if the new required FDA study won't be finished by then?

Also interesting is that I talked with an Hemispherx insider in Dec 2010 and they said that it would not be ready to go back to the FDA for about 2 years unfortunately, so how do these two items mesh I wonder?


Currently, antivirals or antiretrovirals are not allowed on the Ampligen protocal so if it does activate viruses as Judy M suggests, it could be a problem for some.

However, there will be an HEB meeting in March with all the providers, hopefully this will shed light on a new and better protocal.

 

[JohnnyD]

This is puzzling - how would they file in 3rd quarter (2011 I assume) if the new required FDA study won't be finished by then?

Also interesting is that I talked with an Hemispherx insider in Dec 2010 and they said that it would not be ready to go back to the FDA for about 2 years unfortunately, so how do these two items mesh I wonder?

What required FDA study are you talking about? The 3rd Qtr filing would be for an amended NDA (the NDA is currently open and active) in order to start a new trial. The amendment is in light of the new xmrv data. This is all public info.

Currently, antivirals or antiretrovirals are not allowed on the Ampligen protocal so if it does activate viruses as Judy M suggests, it could be a problem for some.

New formal protocols were filed last November -- I would be very surprised if they include antiretrovirals. I did find it interesting that Mikovits stated that they are looking at combo therapy and that "the company has a has a very long history of working with and knowing the safety protocols of the antiretrovirals." Maybe for a trial next year is my thinking.

 

[anncavan]

XMRV Antibodies

Hello all,
I just came across this string today. Wow. Good information. I am talking with Bateman's clinic, and plan to go to SLC for my eval in the next few months.

I have XMRV. I was serology negative (i.e. no antibodies to xmrv) and culture positive. Based on what I've read, this means Ampligen would have no antibodies to activate and therefore create "a hornets nest," as someone put it, in my case.

Does anyone have a link to where this information was shared/housed? I'd really like to read more about it...

Thanks much in advance for any help!!!

 

[jonjonson]

Hello all,
I just came across this string today. Wow. Good information. I am talking with Bateman's clinic, and plan to go to SLC for my eval in the next few months.

I have XMRV. I was serology negative (i.e. no antibodies to xmrv) and culture positive. Based on what I've read, this means Ampligen would have no antibodies to activate and therefore create "a hornets nest," as someone put it, in my case.

Does anyone have a link to where this information was shared/housed? I'd really like to read more about it...

Thanks much in advance for any help!!!

Info from heb....

The XMRV antibody positive cohort had a greater relative percentage of subjects showing a >25% increase in ETT with Ampligen treatment compared to placebo than the XMRV antibody negative cohort. The results also suggest that the XMRV antibody negative subjects with CFS have a lower activity level and a reduced ability to complete normal daily activities at baseline. If validated as a relevant basis for targeting the XMRV positive CFS patient sub-population, the observed response advantage of the XMRV may translate into needing a smaller sample size for future research using a placebo-controlled parallel design to obtain 80% power (α=0.05): 216 XMRV antibody positive subjects vs. 330 XMRV antibody negative subjects. Additional studies to further evaluate XMRV in this CFS population are currently underway.



comment from dr M....
"We've been doing work with Hemispherx using the immune modulator Ampligen, and it's very important because our work shows in a full third of the patients, Ampligen is actually turning on the virus and that's a bad thing, and we know people respond very badly. But in some, it turns it down, and in others, it stays the same. So we're looking at combination therapy, and the company has a very long history of working and knowing the safety protocols of the antiretrovirals. We'e all heard of the GcMAF. That's another immune modulator. I have the same fear of this one, stem cell therapies and Peptide T--is that they can actually increase expression of viruses from viral reservoirs. And that's not necessarily a bad thing, cause you can go get it, if you come right behind it with an antiretroviral and stop it from seeding new reservoirs and clear the reservoirs. So that is a hypothesis we're working on to deplete those reservoirs with these immune modulating drugs, and prevent infection of good cells, and in the case of stem cell therapy, put back that cell, even if we don't know what it is."


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The assumption Im operating under is that the third which get activated are mostly in the antibody neg group.....

 

[jonjonson]

This is puzzling - how would they file in 3rd quarter (2011 I assume) if the new required FDA study won't be finished by then?

Also interesting is that I talked with an Hemispherx insider in Dec 2010 and they said that it would not be ready to go back to the FDA for about 2 years unfortunately, so how do these two items mesh I wonder?


Currently, antivirals or antiretrovirals are not allowed on the Ampligen protocal so if it does activate viruses as Judy M suggests, it could be a problem for some.

However, there will be an HEB meeting in March with all the providers, hopefully this will shed light on a new and better protocal.

Heb is in the process of adding xmrv data to the First phase III.....

This is to establish a subgroup for the larger study which hasnt begun yet.....


More than likely this study will be with those who have xmrv and are antibody positive.....

 

[JohnnyD]

The assumption Im operating under is that the third which get activated are mostly in the antibody neg group.....

annacavan, as jon says we are theorizing on why ampligen increases xmrv copy in about a third of the cases. I expect we'll get a more definitive answer when the company and Mikovits are through with the retrospective look at the 516 trial... and/or when they amend the NDA in the 3rd qtr. the piece jon quoted above is from early data and I expect they are about through or have enough data by now to draw some definitive conclusions... we just have to wait and see what they are.

 

[JohnnyD]

Also, here is an interesting and related article on immune activation:

Immunization Provokes XMRV Activation in Monkey Model

http://www.ageofautism.com/2011/02/immunization-provokes-xmrv-reactivation-in-monkey-model.html

This finding caused Dr. Vincent Racaniello, a Columbia University professor on virology to note in his weekly blog, "One animal produced virus after immunization; perhaps immune activation results in cycles of virus production."

 

[jonjonson]

Also, here is an interesting and related article on immune activation:

Immunization Provokes XMRV Activation in Monkey Model

http://www.ageofautism.com/2011/02/immunization-provokes-xmrv-reactivation-in-monkey-model.html

This finding caused Dr. Vincent Racaniello, a Columbia University professor on virology to note in his weekly blog, "One animal produced virus after immunization; perhaps immune activation results in cycles of virus production."

JD Id like to add this bit....


In their study the authors noted that, "In contrast, antibody responses were clearly elicited after the initial infection (Figure 5), boosted following reinfection, as well as after immunization." (p. 10) This finding caused Dr. Vincent Racaniello, a Columbia University professor on virology to note in his weekly blog, "One animal produced virus after immunization; perhaps immune activation results in cycles of virus production." HERE



Whats interesting here is the comment about the antibodies....

When the monkeys were initially infected they produced antibodies......just like with influenza....


The question that seems to be the biggest for those with cfs is why dont some people produce antibodies.....



does the virus prevent those antibodies from being made.... disable the immune system...


or for those who dont produce antibodies have some sort of disfunction in producing antibodies .....an immune disfunction.....


For me what is evolving from the most recent work gives me a viral model of what ampligen does as treatment for cfs....



Kinda funny donchathink JD all this work on antibodies all of a sudden.....

 

[pine108kell]

Your post seems narrow minded at best.....

I don't appreciate being called narrow minded. There enough is not enough known about XMRV and CFS to make this suggestion about Ampligen. Why is it narrow minded to mention that the current evidence with a number of labs does not show a link between CFS and XMRV? Just a fact. It is not narrow minded to lay out ALL the evidence, not just what one lab has found or what one reseracher thinks.

Also, my understanding is that the earlier study found that ampligen was more effective with those that tested posititve for XMRV antibodies. Maybe this next study is different, but I do not understand how you know that Mikovits has the "right data" when most of her collegues don't think she does. That is, there is the opinion that her data showing XMRV in CFS patients may be faulty. Maybe she does have the "right data", but in my opinon she is speculating too much in public, and it will bite her in the end. Good research science builds facts slowly, one carefully from another. Good science doesn't make postulates and then form a string of conclusions from them.

I am glad WPI exists and maybe they will help us someday. I don't like some of their PR.

 

[JohnnyD]

The question that seems to be the biggest for those with cfs is why dont some people produce antibodies.....

Good question, Racaniello speculates a cycle of immune activation. Maybe a disease cycle? Like cancer, maybe the immune system doesn't recognize the virus as an outside invader?

Kinda funny donchathink JD all this work on antibodies all of a sudden.....

Have you searched for other similar kinds of antibodies studies? Anything similar in HIV or HLTV I wonder? If there are none or few, very interesting indeed.

 

[jonjonson]

I don't appreciate being called narrow minded. There enough is not enough known about XMRV and CFS to make this suggestion about Ampligen. Why is it narrow minded to mention that the current evidence with a number of labs does not show a link between CFS and XMRV? Just a fact. It is not narrow minded to lay out ALL the evidence, not just what one lab has found or what one reseracher thinks.

Also, my understanding is that the earlier study found that ampligen was more effective with those that tested posititve for XMRV antibodies. Maybe this next study is different, but I do not understand how you know that Mikovits has the "right data" when most of her collegues don't think she does. That is, there is the opinion that her data showing XMRV in CFS patients may be faulty. Maybe she does have the "right data", but in my opinon she is speculating too much in public, and it will bite her in the end. Good research science builds facts slowly, one carefully from another. Good science doesn't make postulates and then form a string of conclusions from them.

I am glad WPI exists and maybe they will help us someday. I don't like some of their PR.

Let me just say I didnt call you narrow minded just the post....


I have no desire to get into a long discussion with you about all the studies yada yada.... but I strongly disagree with your comments....


dr M should know more than almost anyone becuase heb has paid her for the last 18 months to determine who treatment with ampligen will benefit....

 

[JohnnyD]

There enough is not enough known about XMRV and CFS to make this suggestion about Ampligen.

but I do not understand how you know that Mikovits has the "right data" when most of her collegues don't think she does.

No researcher or doctor can make known all they know about ampligen - the drug is not approved for anything and falls under strict FDA rules about claiming efficacy. Statements are always qualified. The simple fact that she thinks the work is important is telling, IMO. If early data pans out e.g. that ampligen is more effective with xmrv+ antibody+ patients, then in effect you have a therapeutic bio-marker for a CFS sub-group because the data they are sampling is from a double blind, placebo controlled pivotol Phase 3 trial (the data doesn't get anymore "right" than that). None of Mikovits's collegues have access to this data.

I'm new on the forum, so maybe I'm missing something, but it sounds like you have some kind of axe to grind with Mikovits, the Science study and the WPI?

 

[jonjonson]

Good question, Racaniello speculates a cycle of immune activation. Maybe a disease cycle? Like cancer, maybe the immune system doesn't recognize the virus as an outside invader?



Have you searched for other similar kinds of antibodies studies? Anything similar in HIV or HLTV I wonder? If there are none or few, very interesting indeed.

If antibodies are as integral to the solution as some research may indicate..... then quite a good treatment may be possible...

Antiretrovirals would be an intermediate step but therapeutic antibodies would be an excellent possibility I might think....

 

[garcia]

If antibodies are as integral to the solution as some research may indicate..... then quite a good treatment may be possible...

Antiretrovirals would be an intermediate step but therapeutic antibodies would be an excellent possibility I might think....

Personally I think whether or not you produce antibodies to XMRV might be a proxy-indicator of how healthy your immune system is.

Healthier immune system will produce antibodies, and is more likely to respond to something like ampligen. It's not necessarily the case that it is the antibodies themselves which are producing the benefit.

 

[pine108kell]

I'm new on the forum, so maybe I'm missing something, but it sounds like you have some kind of axe to grind with Mikovits, the Science study and the WPI?

I wouldn't call it an "axe to grind" but, yes, based on numerous other studies it appears probable that the Science study was flawed. It's still possible that it was not, but I would not make decisions about treatments (eg. ampligen) based on that one study that is being contradicted on a continuous basis. That was the point I was making to someone who was wondering if they should try ampligen.

I hope the best for WPI; I hope they don't stay entrenched with XMRV if it is proven to not be related to CFS. I will support them financially if they remain open-minded and are more careful with their statements. If it becomes obvious that XMRV has nothing to do with CFS, which seems to be getting closer daily, then what does the advice that XMRV+ patients not take ampligen mean then? People will only lose confidence in what they are saying and none of us need that.

 

[JohnnyD]

I wouldn't call it an "axe to grind" but, yes, based on numerous other studies it appears probable that the Science study was flawed.

Well, I've got to be with Jon Johnson on this one.... I could not disagree more. The Science paper was confirmed by Alter, Lo et al., no one has undertaken a true replication study, and the AMP 516 retrospective certainly appears to confirm the Science paper as well. There are no politics involved in a double blind placebo controlled trial. When Mikovits states that she 'thinks the politics will go away shortly' - she could be talking about any number of things, but one strong possibility is this retrospective data on the 516 shows a secondary, therapeutic bio-marker. We shall see.

 

[anncavan]

Hi all. First off, thanks for sending me more info a day or so ago. I just haven't had it in me to log on. But I'm back and this is all very helpful.

This antibody discussion is an interesting one. During the talk in Santa Rosa, Mikovits made it a point to say that her sickest patients are testing XMRV serology (antibody) negative but XMRV culture positive. She basically said their systems were so sick they couldn't even produce the antibody. I've heard that Dr. Deckoff-Jones(can't remember if it was Santa Rosa or on her X Rx blog) was originally XMRV serology negative, XMRV culture positive. But after being on ARV's for a while she started producing antibodies and her XMRV serology test came back positive.

Maybe those of us who want to do Amp should start ARVs in an attempt to get a little "healthier" or to get our antibodies going? Speculation, speculation. I just don't know...

 

[jonjonson]

Hi all. First off, thanks for sending me more info a day or so ago. I just haven't had it in me to log on. But I'm back and this is all very helpful.

This antibody discussion is an interesting one. During the talk in Santa Rosa, Mikovits made it a point to say that her sickest patients are testing XMRV serology (antibody) negative but XMRV culture positive. She basically said their systems were so sick they couldn't even produce the antibody. I've heard that Dr. Deckoff-Jones(can't remember if it was Santa Rosa or on her X Rx blog) was originally XMRV serology negative, XMRV culture positive. But after being on ARV's for a while she started producing antibodies and her XMRV serology test came back positive.

Maybe those of us who want to do Amp should start ARVs in an attempt to get a little "healthier" or to get our antibodies going? Speculation, speculation. I just don't know...

Based on recent comments from dr M.....


IMO an opinion probably not worth much......


dr M talked about how ampligen would be used but then followed up with an antiviral....


What that treatment showed from a scientific basis is that xmrv has the ability to shut down the production of antibodies.....


This is different than having some defect in the immune system.....



Reducing the viral load it appears turns off whatever is preventing the production of those antibodies.....



So in my opinion(remember the value of that) I agree with dr M(funny) that because xmrv hides it must first be activated then attacked.....



Treat with ampligen ....if activation occurs treat with antiviral seems the most logical approach.....

 

[jonjonson]

<<I've heard that Dr. Deckoff-Jones(can't remember if it was Santa Rosa or on her X Rx blog) was originally XMRV serology negative, XMRV culture positive. But after being on ARV's for a while she started producing antibodies and her XMRV serology test came back positive.>>


I think this is an excellent issue for discussion.....

Its my major question ....


some patients often the sickest are antibody negative....

why is that????


it seems like its one of two possibilities....


either the virus has shut down the ability to produce the virus neutralizing antibodies....


or there is some defect in the immune system which prevents it from producing the antibodies....


based on what you just posted IMO it seems likely the virus itself has the ability to shut down that antibody producing machinery......