Ampligen® is an investigational, intravenously delivered drug that has been tested in clinical trials involving ‘chronic fatigue syndrome’ (ME/CFS) patients for years. It is classified as a toll-like receptor (TLR) activator, which means its mode of action would be as an agent that activates TLRs to induce immune cell responses to pathogens.
Ampligen’s maker, Hemispherx Biopharma (HB), awaits the FDA’s decision on its New Drug Application, due May 25. And recently HB’s Medical Director, Dr. David Strayer, presented the latest trial findings at the 2009 IACFS/ME Conference (Mar 12-15) in Reno. The trial involved patients treated at 12 clinical sites in the U.S.
You can now click through the slides Dr. Strayer used in this presentation, at HB’s website (www.hemispherx.net). (At the same time you will hear audio, not linked to the slides, from a webcast the company held Thursday Mar 19 to discuss its year-end 2008 results.) You’ll have a choice of versions employing Windows Media Player or RealPlayer.
The Title of the Slide Presentation:
“Interferon and Cytokine Levels in a Double-blind, Randomized, Placebo-controlled Phase III Clinical trial (AMP-516) of Poly I: Poly C12U (Ampligen®) in CFS.”
Authors: Strayer DR, Stouch BC, Horvath JC, Stevens SR, Carter WA. Hemispherx Biopharma Inc., Philadelphia, Pennsylvania; University of the Pacific, Stockton, California.
Investigators at the 12 sites: Drs. Bateman, Bellesorte, Cimoch, John, Keller, Lapp, Mercandetti, Peterson, Papernick, Podell, Stein, Taylor.
A Few Notes:
• Trial subjects were diagnosed with CFS, duration at least 12 months, and fell between 40 and 60 on the Karnofsky scale of functional impairment.
• Ampligen (or placebo) was delivered via IV infusions lasting about 30 minutes, twice weekly for 40 weeks.
Measured results included:
– Treadmill test of peak exercise duration
– Change from initial use of concomitant medications related to CFS
Mean (average) results for exercise duration (change from baseline to week 40):
– For those receiving Ampligen – improvement from 576 seconds to 672 seconds.
– For those receiving placebo – improvement from 588 seconds to 616 seconds.
More specifically, the mean percent of subjects who improved exercise duration:
– At least 25% – was 39% with Ampligen, vs. 23% with placebo
– At least 50% – was 26% with Ampligen, vs. 14% with placebo
Decrease in use of medications (decrease in number of days individual medications were taken during weeks 36-40 of study vs weeks 1-4):
– 72% of Ampligen group reduced medication use, vs. 56% of placebo group
– 26% of Ampligen group did not decrease med use, vs. 44% of placebo group
Visit www.hemispherx.net for more detail.