Hemispherx Encouraged by Cytokine Biomarker Discovery Which May Lead to a Diagnostic for Chronic Fatigue Syndrome

PHILADELPHIA, Aug. 04, 2017 -- Hemispherx Biopharma (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.” (http://med.stanford.edu/news/all-news/2017/07/researchers-id-biomarkers-associated-with-chronic-fatigue-syndrome.html)  The research was published Monday July 31^st, in The Proceedings of the National Academy of Sciences (http://www.pnas.org/content/early/2017/07/25/1710519114.full) and was also mentioned on ABC’s Good Morning America (https://www.yahoo.com/gma/study-sheds-light-chronic-fatigue-syndrome-131405106--abc-news-wellness.html).

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.”

About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx’s flagship products include Alferon N Injection® and the experimental therapeutics rintatolimod (tradenames Ampligen® or Rintamod®) and Alferon® LDO. Rintatolimod is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Hemispherx’s platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Because both rintatolimod and Alferon® LDO are experimental in nature, they are not designated safe and effective by the FDA for general use and are legally available only through clinical trials.  

Cautionary Statement
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties.  For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.  In addition to the risk factors identified from time to time in our reports filed with the Securities and Exchange Commission, no assurance can be given that this biomarker will result in a reliable diagnostic test for ME/CFS.   Any forward-looking statements set forth in this press release speak only as of the date of this press release.  We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.hemispherx.net. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

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