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Monday, May 06, 2019

Chronic Fatigue Syndrome patients may be one step closer to Ampligen.

Hemispherx Links Stanford's ME/CFS Diagnostic to a Potential Path Forward for Ampligen Commercialization
OCALA, Fla., May 06, 2019 (GLOBE NEWSWIRE) -- Hemispherx Biopharma Inc., (NYSE American: HEB), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers and immune-deficiency diseases - and whose product portfolio includes Ampligen, commercially approved in Argentina, as the world's only approved therapeutic for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) - announced today that the impressive results from a blood-based, real-time diagnostic test out of Stanford University demonstrates an ability to identify moderate to severe ME/CFS patients from normal controls. Currently ME/CFS is a disease of exclusion from other diseases, which manifest similar signs and symptoms with no specific ME/CFS laboratory diagnostic assay to aid the physician in a definitive diagnosis.
While Hemispherx is currently focused on Ampligen in the treatment of cancer, for which there are multiple ongoing trials, regulatory approval of Ampligen in the treatment of ME/CFS in the United States is also a corporate goal. Profound fatigue is a universal symptom of severe ME/CFS and its quantitative documentation is a challenge. A functional ME/CFS diagnostic may remove this obstacle. Using blood samples from twenty patients with ME/CFS versus twenty normal controls, Stanford researchers were able to identify which samples came from people with ME/CFS by measuring the electrical impedance of the patient's immune cells and plasma when osmotically stressed through exposure to high salt concentrations. The research was recently published in the Proceedings of the National Academy of Sciences:
"This is a potentially landmark study on two fronts," said Thomas K. Equels, CEO of Hemispherx. "First, ME/CFS has been thought of by many as a psychological disorder without a physical basis, leaving ME/CFS sufferers with the pain of the disease and a sense of hopelessness. This diagnostic creates a new paradigm of hope for therapy for those with the disease. Second, a validated blood-based method to diagnose ME/CFS would have a profound impact on how it is studied and treated by clearly identifying whether a subject has the disease. We look forward to the day when we can incorporate such a diagnostic platform into our own clinical testing for ME/CFS. We have the only late-stage drug candidate in the FDA pipeline and have been asked to do a confirmatory clinical trial. If properly validated with larger numbers of subjects, a blood-based diagnostic for ME/CFS should help in achieving regulatory approval."
In the United States, Hemispherx sponsors an Expanded Access Program (EAP), known as AMP-511, in which the FDA has authorized use of Ampligen in ME/CFS patients in an effort to expand compassionate care in the absence of commercially approved therapy.
Stanford's Ron Davis, PhD, professor of biochemistry and of genetics and one of the study's authors, emphasized the importance of a reliable diagnostic platform for ME/CFS in a statement accompanying the journal article, stating "...there is scientific evidence that this disease is not a fabrication of a patient's mind. We clearly see a difference in the way healthy and chronic fatigue syndrome immune cells process stress."
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