Hope for Ampligen-Breaking News!

I've been sitting on this story for a couple months now at the personal request of a couple physicians who were "on the fence" but I can now share with those who are interested in getting Ampligen, the future might be a little brighter.

As you read this currently there are a number of the most well-known ME doctors, and some others, meeting with Hemispherx Pharma, (the makers of Ampligen) at a meeting in Florida. The main reason for the gathering this long weekend is so that Hemispherx can announce and explain their new "widened enrollment" plan for Ampligen trials. Hemispherx filed and was approved to expand to more doctors and clinics the testing of Ampligen in what they call CFS/ME, stating:

"In conjunction with this ongoing analysis of the Companys AMP-516 study, which is an integral part of NDA 22-151, Hemispherx is also initiating a widened enrollment of the open label AMP 511 study to increase the number of observations relating to potential interrelationships of XMRV, CFS symptoms and poly I: poly C12U (Ampligen)."

So the good news for patients is that "widened" means "more doctors in more cities!"

Hemispherx reported that they are taking this seriously. For the first time they have hired a new staff dedicated to the recruiting and approval of new clinics and physicians. So in the USA, instead of only having a choice between Dr. Lapp in Charlotte, and Dr. Peterson in the Reno area, we have confirmed that Hemispherx has recruited others including:
and others!

The meeting this weekend in Florida will also present to these doctors some new aspects of the AMP 511 study, to now include, if not be keen on, XMRV.

So "expanded" also means that all new patients in trials will have XMRV tests and markers done at baseline and throughout the study. Because we already know from published reports that patients with XMRV have and do respond well to Ampligen we now have a definitive end-game in sight for the ultimate, long-awaited approval of this drug. In short, with more Doctors doing the study, better screening, and results that will among other things, show positive response against XMRV, the days of Ampligen being in "limbo" could be over soon.

The other bit of good news is that the new protocol allow more latitude with certain patient medications, and drug holidays. When I was on the AMP 511 trial last year, we HAD to get our infusions and average of every 3 days, come rain or shine. We also had to completely cease and desist almost every other medication that was helping us, including most antivirals, and immune modulators like Nexavir. The new protocoal they are announcing to physicians this weekend is more liberal- it allows for short "drug holidays" as well as allowing more latitude in certain meds you can stay on while doing the Ampligen trial.

I'll have a follow-up report post-Florida conference to add to this post if any other revelations come out of Hemispherx over this weekend.

Until them I am praying that the meeting is well-received, that many many more doctors jump into the mix, and that many more patients will be able to at least consider Ampligen, by way of having more locations available.


Thanks for the update Kelvin. But any expansion will still require that patients pay out of pocket the full cost of Ampligen, or no?
Regarding costs, there are two issues.
There is the cost of the drug itself, and then there are costs associated with getting the drug--that is, if you don't happen to live near one of the Doctors, then you either commute, or move there. If the trial "expansion" they discuss this weekend remains "cost recovery," like I did with Dr. Lapp, then the drug costs you'll have to pay for include the Ampligen, the infusion supplies, and nurses' time. Ampligen in cost recovery costs the patient $95/vial. You use around 16 vials per month. When you add in supplies and the nurse you end up with a rough outlay of about $2000/month in "cost recovery."

But if you move to a new city to get this drug for 6 months, or like I did for 12 months, then you have the costs of living tacked on to that. I probably spent an additional $2000/month just on housing and transportation.

There is a chance, based on rumor only, that Hemispherx this weekend might be announcing a "double blind" trial. If that is the case then you have the situation where the medicine and infusion costs are paid for by the drug company, but unfortunately, only 50% of the patients getting infusions get the real Ampligen. So you save money, but you are flipping a coin as to whether or not you are actually getting Ampligen in your veins, or saline. That's the nature of a "double blind" trial. If that is reported this weekend I will post it here.

Ultimately of course what we want is for Ampligen to be approved, so that whether you live in Pacoima, Potosi or Portland, YOUR local doctor can prescribe the medicine, and YOUR insurance can pay for it.
Kevin thanks for this and your updates. They have a ""TARGETED" audience and they need to get the treatment to them. We "the XMRV" positive desperately need Ampligen. God help us all.

The supply and demand formula is a reality, I hope something can be done to get this medication to us..
Thanks for the info, Kelvin! 4 questions:
are participants in the study required to have an xmrv positive test?
are participants tested for xmrv as part of the study?
do you think their will be any docs in the los angeles area doing testing?
how have you been able to get antivirals? my doc told me she can't prescribe them because she wouldn't know what to prescribe.

Thanks, again!
Thanks for the info Kelvin! I wonder what the current eligibility is for Ampligen- do you need to have certain viral titers high? Thanks!
Will VIPdx be the company used to test for XMRV?

If not I would have little confidence in the XMRV test.

Blog entry information

Kelvin Lord
Last update

More entries in User Blogs

More entries from Kelvin Lord