Ampligen

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Hi guys im from the UK, This may be the million dollar question but is there any indication as to when a decision may be made on Ampligen getting a drug licence for ME/CFS in the USA?!

thanks all, Dave.
 

Cort

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Our first post! I talked with Mary McGorty - the public relations person for Hemispherx - at the CFSAC meetings. She shows up for all of them by the way - she's very active.

The deadline for Ampligen was pushed back again - the second time this year - but not because of anything Hemispherx did - the FDA is just swamped apparently. It hasn't helped that Ampligen has bounced around different departments at the FDA as they tried to figure out what kind of disease ME/CFS is. Mary did tell me, though, that FDA researchers had checked out all the different facilities and they checked out fine.

When they'll make a decision, though, is anyone's guess - hopefully sooner rather than later.

Thanks for the first post!
 

Cort

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Ampligen was back in the news. Apparently we should know in just be a few weeks. A Business correspondent, though, just reported that Dr. Bell, the head of Hemispherx, is back up to his old tricks - over stating results, recycling old research as if it was new. Hemispherx has a terrible reputation that's for sure but it'll be such an ace for us if FDA approves. I talked with Kim McCleary and the subject of Hemispherx briefly came up - she didn't say much the tone in her voice!!! Their liason Mary McGrorty is great though.


http://aboutmecfs.org/Trt/AmpHist.aspx
 
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Would be a great benefit if it we're approved..so much politics and red tape. Could this be the time?...I hear within 10 days a decision should be made...but we've heard this many times before :mad:.....Mike
 

Cort

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10 days! they must be sweating bullets over there. Their stock is in the dumps. If it doesn't go through I wonder if the company is finished.

The mantra has always been good product - bad company. At the last CFSAC meeting I talked to Kim McCleary and for some reason Hemispherx came up. I could hear the distaste in her voice.

Still if it goes through what a windfall for ME/CFS; recognition of it as an immune disease - more legitimacy - treatment option that definitely helps some people very much. Apparently the drug companies were shocked, absolutely shocked at the demand for Lyrica for FM patients.

Crossing my fingers! Ten days - after almost 20 years - ten days!
 

hvs

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If the FDA approves Ampligen it necessarily subscribes to the view that CFS has a viral root (or driver which, once put to bed, allows recovery). (For the core Incline Village subset, this is absolutely true.)

If it does that, it puts it at odds with the CDC which has been covering its failure to identify the role of viruses for 25 years.
 

hvs

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I agree that viruses might merely be the driver for something that might have a root in genes, but in that case don't you think we shouldn't see it in outbreaks or in families?
 

Cort

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I don't know if this was posted elsewhere or not: From Adam Feurstein - someone who's been all over Hemispherx - he doesn't trust them and he's after them.

It looks like Hemispherx could be having problems meeting FDA standards for manufacturing.

http://www.thestreet.com/_yahoo/story/10597681/1/hemispherx-hasnt-called-fda-on-ampligen-review.html

Hemispherx Hasn't Called FDA on Ampligen Review

HEB , AMAG Adam Feuerstein


NEW YORK, N.Y. (TheStreet) --Hemispherx Biopharma(HEB Quote) CEO William Carter finished his 20-minute investor presentation here Wednesday, and the floor was opened for questions.

More from Adam FeuersteinPsst... These Drug Firms Are Getting Bought: BioBuzzBioCryst Warns Peramivir Sales May Not Bring Profits: BioBuzzNew Medicare Rules for Dialysis Affect Biotech: BioBuzzBullish Case for Vanda Loses SteamDueling Views of Arena Pharma: BioBuzzBioCryst Still Waiting for Flu Drug Deals: BioBuzzTakeout Rumors Lift Dendreon, Bio Stocks: BioBuzzAuxilium Shares Higher On FDA Drug Review: BioBuzzXOMA to Repay Goldman Loan: BioBuzzCell Therapeutics CEO Sells Stock: BioBuzz
Market ActivityHemispherx Biopharma Inc.| HEB
DOWN
"When was the last time you or anyone at Hemispherx had contact with the FDA regarding the status of the Ampligen application," I asked, referring to the agency's ongoing, and now long-delayed and controversial review of Ampligen for chronic fatigue syndrome.
"Yesterday," Carter replied, adding that the company had just sent an annual report on Ampligen to the FDA.

Carter is skilled at responding to questions with a non-answer, so I raised my hand again and was more direct.

"What I want to know is when was the last time you or someone at Hemispherx picked up the phone and had an actual conversation with FDA where you asked what's going on with the Ampligen review?"

"We have not called them and asked them that question," Carter responded.

"So, to be clear, no one at Hemispherx has called the FDA and asked, 'We were supposed to hear from you on May 25 but it's now September 9.' You never called them to ask?"

Said Carter, again, "No, it's our belief that, in good time, the FDA will respond to us. In the meantime, we're cleaning up certain issues related to the pre-approval inspections of the drug."

It was a brief exchange held at the end of Carter's presentation at Rodman & Renshaw's investor conference in New York City, but it was illuminating nonetheless. In fact, it might be the first time that Carter has spoken truthfully about Ampligen and the FDA. I actually believe Carter when he says that he hasn't called the FDA to ask why Ampligen's approval decision is now more than 100 days past due.

As the crowd in the New York Palace Hotel's meeting room was breaking up to make way for the next presenting company, I walked up to Carter, introduced myself, and asked him to more fully explain what he meant when he said the company was "cleaning up certain issues" with the FDA.

On numerous occasions since May, Carter has stated that the company wasn't aware of any deficiencies in the Ampligen data package and that the FDA hasn't asked the company for any additional information.

His answers to my question at the Rodman conference suggested a change to that stance. More specifically, I wanted Carter to explain why the company made a small but seemingly important alteration to the wording of its quarterly reports filed to the Securities and Exchange Commission.

Hemispherx is working with its contract manufacturer Hollister-Stier Laboratories to resolve two deficiencies in the Ampligen fill-finish process found by FDA inspectors working out of the agency's district office in Seattle.

In previous quarterly reports to the SEC, Hemispherx stated that it, along with Hollister-Stier, had "submitted a specific action plan" to address the manufacturing deficiencies -- known as a 483 letter in FDA legal parlance -- found by the FDA's inspectors.

Hemispherx added new language to this section of its most recent 10-Q filed on Aug. 7. It reads: "It is our expectation that these issues will be resolved and we will be able to complete the resultant sequential validations by the end of 2009.""
 

dannybex

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I posted another article...

...from Feurstein on the Ampligen approval thread in the General News section:

http://forums.aboutmecfs.org/showthread.php?t=172

At that point he didn't think it would ever get approved, because they kept fudging/changing the study's data...from 17.4, then 19.3, to finally a 12.9 percent improvement:

Quoting Feurstein:

"The abstract clearly states that the 12.9% improvement in exercise performance between Ampligen and placebo patients was not statistically significant, with a p value of 0.052. Any result with a p value of greater than 0.05 is deemed not statistically significant.

Simply put, Hemipsherx's phase III study of Ampligen in patients with CFS was a failure."

http://www.thestreet.com/story/10506671/1/hemispherxs-cfs-drug-is-a-long-shot.html

Personally, even though it's been a (temporary) life-saver for some patients, I don't think it'll be approved because of it's checkered past, but mainly because of it's exorbitant cost, especially compared to other immune modulators...
 

hvs

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I think part of the point of WPI's interest in translational medicine is that they will identify which patients will benefit from which therapies. It'd be good to have ampligen available to them to give to targeted patients. There's little question that ampligen's helped a good number of people who came out of remission when the drug was taken away.
 

Scavo86

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Is it still possible to get Ampligen in Belgium and, if so, where does one go? Secondly, who do us UK lads and lasses lobby if we would like to see a trial over here? Thanks in anticipation of the answers guys :D
 

garcia

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Is it still possible to get Ampligen in Belgium and, if so, where does one go? Secondly, who do us UK lads and lasses lobby if we would like to see a trial over here? Thanks in anticipation of the answers guys :D
Anyone know the answer to the above? Is Ampligen available in Europe at all? If so, where?

many thanks,
garcia.
 

Daffodil

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i would call dr. demeirleir's office and ask the secretary if he is still using ampligen or where to get it:

Phone: +32 2 481 53 10
 

BEG

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I believe this drug is not the panacea that many think it is. (Except for Mary Schweitzer) I was in a Phase III trial and had to drop out because I was allergic, but I kept in contact with a couple of fellow patients. If there was a miracle in my group, I never heard about it.
 

Sunshine

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Anyone know the answer to the above? Is Ampligen available in Europe at all? If so, where?

many thanks,
garcia.
Hi. Looking back a decision was due to be made by summer 2009 (in Europe) on Ampligen being allowed into Europe to treat CFS. In 2008 there was real hope Ampligen may well pass EU laws. No news being released on the matter since means Ampligen must have been refused on safety grounds in the EU as the FDA blocked it in America and the EU officials would have cited this.

The last time Ampligen was blocked by the FDA it showed a very small increase in V02 max function (exercise testing) in American patients with CFS. Presumably not enough to demonstrate Ampligen to be classed as a licensed drug and/or it was denied due to political reasons.

More positively I heard there was going to be or there is ongoing?...... an Ampligen trial in CFS in America measuring Natural Killer Cell function in those who are XMRV+. If NKC function was demonstrated to be improved, there would be grounds for Ampligen to be allowed as an immune drug for improving NKC function in XMRV rather than as a therapy for CFS which is wrongly accused of being a psychosomatic lifestlye choice by the CDC. and UK National Health Service.

the American FDA classifying Ampligen as an immune modulator for XMRV (rather than CFS) would allow the American government/FDA to save face and deny any link of CFS being any form of immune disorder yet simutaneously finally allow Ampligen to be passed for 'other conditions'. Also this way the CDC could still deny CFS is anything to do with impaired NKC function, despite the overwhelming scientific evidence. Again this would be done by only allowing the drug to be used for XMRV+ with NKC depletion, and not anyone with the label CFS.

This is currently the best we can hope for, yet within 3-5 years I imagine the WPI will have something up their sleeves for us in term of basic non antiretroviral drug treatment for neuro immune CFS.

It's a great shame Ampligen never came to Europe in 2009, and only continues to be used in America by around 4 named individuals. 4 doctors, for 17 million people at up to $20,000 per year for the IV drug rarely works out as an effective way to attempt a basic treatment for a chronic disabling organic disease in persons with very low incomes due to severe disabilty and social exclusion.
 

heapsreal

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i think improving natural killer cell function is going to be our answer as alot of our infections i believe are opportunistic, even if xmrv is the cause, good nk cell function will help keep a lid on it. Poor nk cell function could/should almost be a diagnostic tool for cfs.
Has there been any recent studies on immunovir and nk cell function, as this is a cheaper drug and easier access to most of us now then ampligen, although ampligen appears to be alot stronger.
 

garcia

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i think improving natural killer cell function is going to be our answer as alot of our infections i believe are opportunistic, even if xmrv is the cause, good nk cell function will help keep a lid on it. Poor nk cell function could/should almost be a diagnostic tool for cfs.
Has there been any recent studies on immunovir and nk cell function, as this is a cheaper drug and easier access to most of us now then ampligen, although ampligen appears to be alot stronger.
In Japan ME/CFS is more popularly called Low Natural Killer (cell) Sydrome (LNKS).

Unfortunately I'm already on imunovir, and whilst it has helped somewhat, it is very very far from being any type of cure.