Recently on January 12, 2015, the Company issued a report entitled "Low Natural Killer (NK) Activity Observed Across the Chronic Fatigue Syndrome (CFS) Disease Spectrum" that a biomarker natural killer cell cytotoxicity (NKCC), when low, was associated with more symptom severity and debilitation. This report has now been submitted as a scientific paper for peer-review and publication. The report includes a summary of 6 publications totaling over 150 CFS patients which indicates a relationship between increased severity of CFS and low NK cell activity. In 15 subjects with CFS studied by the Company, Ampligen(R) treatment of peripheral blood mononuclear cells in vitro increased the mean NK activity over 100%. Clinical testing is presently underway to determine whether or not NK augmentation by Ampligen(R), to the extent it may occur in vivo, is associated with decreased CFS disease severity and, specifically, increased physical performance.
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.