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A test for chronic fatigue; a boon for Hemispherx
October 2017
by Rachel Flehinger  |  Email the author
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PHILADELPHIA & STANFORD, Calif.—A recent study from Stanford University may offer the building blocks for a long-sought diagnostic to test for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), which is estimated to afflict more than one million Americans, according to the U.S. Centers for Disease Control and Prevention. This news is of paramount interest to Philadelphia-based Hemispherx Biopharma, which has a ME/CFS treatment drug, Ampligen, currently in late-stage development.
 
The Stanford study, led by Dr. Jose Montoya, found that people with ME/CFS had blood levels of certain pro-inflammatory cytokines in that correlated with disease symptom severity. These findings suggested a link between excess inflammation and the disease. As stated in a Stanford news release, “When comparing patients versus control subjects, the researchers found that only two of the 51 cytokines they measured were different. Tumor growth factor beta was higher and resistin was lower in ME/CFS patients. However, the investigators found that the concentrations of 17 of the cytokines tracked disease severity. Thirteen of those 17 cytokines are pro-inflammatory.”
 
“There’s still a good deal of work to be done before this important biomarker discovery can be turned into a readily available diagnostic test for ME/CFS, possibly available in a doctor’s office. It represents a seminal breakthrough in developing a diagnostic for ME/CFS in patients whose symptoms are often misunderstood, or even not believed,” said Thomas Equels, CEO of Hemispherx. “This is an important step towards a blood test that could benefit millions around the globe suffering from this severe debilitating disease.”
 
Hemispherx’s Ampligen works primarily as an immune system modulator. In the presence of an immune system failure, it acts as a TLR3 agonist, stimulating a cascade of alpha, beta and gamma interferons that help stimulate the immune system and fight disease. Its enormous promise was first demonstrated during the Ebola crisis in Africa when the U.S. government tested it in highly controlled labs. When Ebola was administered to rats, they found 100-percent mortality from the disease within one week. Rats that were given both Ebola and Ampligen not only had a 100-percent survival rate, but also showed no symptoms of the disease at all.
 
“What makes the Stanford study of importance to [Hemispherx] is it’s focused in the same wheelhouse where our Ampligen therapy targets,” asserts Equels. Ebola is as lethal as it is because it disables the body’s immune system, allowing it to take hold quickly. Likewise, it is thought the ME/CFS is also at its root a disease of the immune system. Though this theory is disputed in the United States, most other countries define ME/CFS as a biological disorder driven by the immune and metabolic systems. Montoya’s findings further indicate the correlation between ME/CFS and the immune system, making it easier to definitively diagnose and then treat at an earlier phase in the disease’s progression.
 
ME/CFS is a truly debilitating disease in its most severe form. Often misunderstood, misdiagnosed or mocked, its confirmed severe cases are terrible. In addition to the overwhelming physical symptoms that leave people bedridden, it also causes the erosion of a person’s mental capacity. Some liken the mental symptoms to early stages of Alzheimer’s disease. Successful early and definitive diagnosis and treatment offer tremendous hope to patients suffering from the disease, and the doctors trying to treat them.
 
According to Equels: “This drug will make a huge impact on those who suffer. They will be transformed from one who is completely bedridden and dependent to someone who is not just no longer disabled, but back to work and productivity.”
 
In 2016, Ampligen became the first therapy ever approved anywhere in the world for ME/CFS, receiving government approval from Argentina. Applications for Early Access Programs (EAP) in Europe and elsewhere are planned in the coming year. In the United States, Hemispherx has completed a pivotal Phase 3 clinical trial in ME/CFS, where it is the only late-stage drug in the pipeline for this disease. The U.S. Food and Drug Administration has advised that potential approval for commercial sale in the United States will depend on the conduct and review of a follow-up confirmatory clinical trial. Ampligen’s immuno-therapeutic properties are also currently being used in pancreatic cancer in a 50-patient EAP approved by the Netherlands.
 
Code: E101720

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