Immune Disorders

Ampligen® for the Treatment of Myalgic Encephalomyelitis or Chronic Fatigue Syndrome (ME/CFS)


Approved for the treatment of Severe CFS in Argentina

Only late-stage program in development in the U.S. for the treatment of ME/CFS

Developing protocol for confirmatory Phase 3 trial, required for U.S. NDA

ME/CFS is a disease characterized by profound fatigue, sleep abnormalities and pain. ME/CFS occurs more commonly in women and the cause of the condition is unknown. It is estimated that approximately 2.5 million people in the U.S. suffer from ME/CFS.1

Positive Results from Phase 3 Study Showed Significant Improvement in the Primary Endpoint, Exercise Treadmill Tolerance (ETT)

Strayer DR, Young D, Mitchell WM (2020) Effect of disease duration in a randomized Phase III trial of rintatolimod, an immune modulator for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. PLOS ONE 15(10): e0240403.

Ampligen® as a Potential Treatment of Long COVID / Post-COVID Conditions

Long COVID (Post-COVID) is a condition in which individuals infected with COVID-19 have prolonged symptoms four weeks beyond the initial infection. It is estimated that long COVID affects nearly one in five Americans who have had COVID-19.