Possible Ampligen 511 trial locations

mojoey

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I spoke with Dr. Bateman's research team yesterday and they are considering re-starting the 511 trial (where you pay for everything, ~20k/year) for ampligen. A big factor in their decision is having enough patients in the trial to make it cost-effective from an administrative standpoint. They said they probably won't start before 2011. I confirmed this with the clinical trial rep at Hemispherx, who says things may move along even quicker than that once they agree on the contract.

I would advise anyone who is interested to contact Dr. Bateman's research team.
 

Otis

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That seems pretty unlikely GG. This isn't even an off-label use - it's totally unapproved.

Best of luck to those to can afford it and are in that area, or are willing to relocate. Keep us up to date, please.
 

OverTheHills

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Mmmm maybe I'm just feelin' suspicious here but is it a good sign or a bad sign for Ampligen approval? Would Dr Bateman do this sort of cost recovery trial if it was about to be approved by the FDA (which is right behind a 1Million lotto win on my fantasy list) - no. On the other hand I suppose she may be doing this to boost the numbers for the FDA safety data. ANyone got a brain in today and can speculate what this means?

OTH
 

mojoey

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I think if they did go ahead with the trial, it'd be because they want patients that can afford it to have access to the drug immediately, and not at the FDA's whimsy.

That being said, I do not think it is "about to be approved" by the FDA. We'll need to hear an announcement of a follow-up phase III clinical trial before we can even go there.
 
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Thanks for posting mojoey, I am so happy to see Ampligen trials expanding. :victory: More studies means more data for Hemispherx, they are also looking to ammend their open label studies to include XMRV testing (per rep 2nd day of CFSAC meeting). So this is all good for everyone. If they can prove that the subset of patients that are improving with Ampligen also have XMRV then this could move the XMRV research forward.

Mojoey - I would love to talk with the clinic trial rep at Hemispherx, could you PM me with contact info? Thanks.
 

LaurelW

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I think she's doing it because patients have been nagging her to ever since she quit over a year ago. I don't think there are any imminent trials out there, but would love to know if anyone has some inside information. I'd also like to know if someone participated in the 511 and suddenly there was a trial available, would it make the 511 participants ineligible? Obviously we need more info. I also wonder if drug companies will jump on the bandwagon after Dr. Singh finishes her study. Anybody got a crystal ball?:rolleyes:
 

Marg

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I leaned of Ampligen in 1994. The CFIDS Association had a toll fee number to call to find out about the latest developments, that was a loooong time ago! Why is the question I would like to hear the answer to. I have started reading "Osler's Web" again.
I read it when it first came out and I had to read a chapter at a time and put it under the bed for a while, it frightened me so much. Well, Hillary Johnson must have had a crystal ball to have written that way back then.
 
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I would advise anyone who is interested to contact Dr. Bateman's research team.
You can reach us through here, or via email - try kristinp(at)fcclinic(dot)com or ali(at)fcclinic(dot)com... we'd really like to learn more about who is interested and what this might turn into.
 

mojoey

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Two more possible locations for ampligen 511 trial

I just heard from Dr. Enlander that he is planning on starting an ampligen trial. I confirmed this with hemispherx. As far as I know, this will be a cost-recovery trial, not phase III, although I asked Dr. Enlander just to make sure.

My contact at hemispherx also told me that a doctor in Princeton is trying to do it, so that may be another location for patient in NJ.
 

George

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Wow sounds like they are really ramping up. Won't this cost them for having to make extra product?? How long has it been since they had this many 511 trials going at once???
 

mojoey

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I'm sure they're not losing money since patients will be paying for the cost of the drug ;) For phase III clinical trial, they'd need to recruit upwards of 700 patients (half of them getting the drug), and the patient wouldn't be paying for that at all. Which just makes it seem that much less likely that the drug will ever get approved with Hemispherx sitting on 50 mil of cash and being oh-so-thrifty with it. Sigh.
 

Sasha

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the patient covers the whole cost: drugs, administration, testing. ~20k/year
This just seems nuts to me - anyone sufficiently seriously ill and for long enough to consider Ampligen would surely have been unable to work for several years. There may be some with sufficient savings or support from a partner to be able to afford it but that must surely be a small number. Very sad that Hemispherx won't invest in their own product.
 

dannybex

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I'm sure they're not losing money since patients will be paying for the cost of the drug ;) For phase III clinical trial, they'd need to recruit upwards of 700 patients (half of them getting the drug), and the patient wouldn't be paying for that at all. Which just makes it seem that much less likely that the drug will ever get approved with Hemispherx sitting on 50 mil of cash and being oh-so-thrifty with it. Sigh.
What Joey said. The drug's been around for 30+ years and has never been approved in the US for any disease. That alone raises red flags -- but for me, it all comes back to the (mis)management of the company.

Think about it. The drug was rejected by the FDA almost a year ago...yet have they even begun to recruit those 700 patients for the new clinical trial?
 

heapsreal

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20K a year, wow! dont they realise that most people are even lucky to be working with this illness, i supose the rich get richer and the poor fend for themselves. Im struggling along working full time but know way i could afford 20K.

cheers!!!
the patient covers the whole cost: drugs, administration, testing. ~20k/year
 

dsdmom

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What Joey said. The drug's been around for 30+ years and has never been approved in the US for any disease. That alone raises red flags -- but for me, it all comes back to the (mis)management of the company.

Think about it. The drug was rejected by the FDA almost a year ago...yet have they even begun to recruit those 700 patients for the new clinical trial?
That's what is so frustrating - I'm not quite sure what benefit they are receiving from doing the open label study - if it's not going to get them approved. I just wish I knew what was going on in their heads. Isn't it in their best interest to get it approved? So wouldn't they want to move forward with the type of studies that will allow that to happen?

On another note, as an FYI - Dr. Bateman in SLC is considering starting up the trial again and they are trying to figure out how many people are SERIOUSLY interested. So if you are, contact them.
 

CBS

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the patient covers the whole cost: drugs, administration, testing. ~20k/year
And, you are very likely to be required to move to the city where the trial is taking place. The testing is also likely to include several weeks before drug administration making sure your don't have any risk factors and very close monitoring for side effects once things get underway (again, all at your expense).