Discussion in 'Institute of Medicine (IOM) Government Contract' started by Nielk, Feb 23, 2015.
HEB and the FDA changed the AMP511 cost recovery trial protocol in November - you can read the changes on clinicaltrials.gov. So the NK clinical testing has been underway since November. There are now three arms to the trial, each with 100 in each arm. 100 ME patients getting ampligen, 100 ME patients not getting ampligen and 100 healthy controls. They measure NK function and compare the arms. The advantage is that you can tell pretty quickly if ampligen is improving NK function or not. So they could stop the testing or advance the testing at any number of patients. The other advantage with this design is that the FDA just saved Hemispherx 20-30 million dollars over the traditional double blind, placebo controlled phase III trial of 600 patients - which is what the FDA originally wanted. Hemispherx has lots of historical data to show NK improvement, the FDA of course wants to see it in real time. Some of the literature showing NK cell function in ME patients goes back to 1998. I think the FDA is going to want to finally catch up.
Hemispherx did good. I think they can show that ampligen improves NK function and that this will lead to an advanced trial under FDASIA rules, probably a phase IV.
Some more news re Hemispherx (not directly related to ME/CFS):
Hemispherx completes $8M manufacturing plant rehab
Mar 6, 2015
And here's a new blog calling for advocacy action in relation to Ampligen. It could probably do with a new thread.
Call to Action: Congressional Hearing on Ampligen
Onward Through the Fog (blog)
From the FDA Action Team
March 5, 2015
These are exciting news, thanks for posting @Nielk @JohnnyD and @Bob!
Things seem to finally start moving somehow for us.
I don't quite understand why they are testing NK cell function, when it is efficacy on symptoms/level of functioning that they are supposed to be demonstrating.
Measuring NK Cell function would only be useful, if it was a biomarker which could be used to determine who would respond to the drug or not.
Did it get a new thread?
I've asked US friends to e-mail.
I posted a thread about that some days ago - Bob Miller will be commenting at some point.
It's had some very interesting discussion:
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