Hemispherx BioPharma, Inc (NYSE MKT:HEB) said today that a new study led by a team of researchers from Stanford University may provide the basis 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.
The study, led by Jose Montoya, M.D., 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 the Stanford Medicine Press Release dated Monday, July 31, 2017, “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.”
One year ago Ampligen became the first therapy ever approved anywhere in the world for ME/CFS, receiving government approval from the Republic of Argentina in August 2016. 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. FDA has advised that potential approval for commercial sale in the U.S. 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.
“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.”
Shares of Hemispherx Biopharma are up nearly 6% to $0.43 in pre-market trading Friday. HEB has a 1-year high of $2.64 and a 1-year low of $0.39. The stock’s 50-day moving average is $0.48 and its 200-day moving average is $0.54.
Hemispherx Biopharma, Inc. is a biopharmaceutical company, which engages in the clinical development of new drug therapies based on natural immune system enhancing technologies for the treatment of viral and immune based disorders. Its products include Alferon N Injection and the experimental immunotherapeutic/antiviral Ampligen. Alferon N Injection is a purified, natural source, glycosylated, multispecies alpha interferon product, composed of eight forms of high-purified alpha interferon. Ampligen includes application as a treatment for Chronic Fatigue Syndrome and as a vaccine enhancer for therapeutic and/or preventative development related to influenza and cancer treatments.