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Philadelphia, PA - October 13, 2009 - Hemispherx Biopharma, Inc. (NYSE Amex: HEB) (the "Company"), announced today that the discovery of a novel retrovirus in CFS may now shed new light on the potential mechanism of action of Ampligen® (Poly I: Poly C12U), an experimental therapeutic, in CFS. CFS is a debilitating disease of unknown etiology that is estimated to affect 17 million people worldwide. In the October 8, 2009 issue of Science Express, a consortium of researchers from the Whittemore Peterson Institute, the National Cancer Institute and the Cleveland Clinic report a new retrovirus in the blood cells of 67% of Chronic Fatigue Syndrome (CFS) patients and 3.7% in healthy control subjects. The infectious virus was also greater than 99% identical to that previously detected in prostate cancer. Patients with CFS are known to display various abnormalities in immune system functions and experience both higher cancer rates and neurological pathology, all of which may be associated with several retroviruses such as HIV and HTLV-1.
Presently, the Company is actively collaborating with the Whittemore Peterson Institute to evaluate the potential role of Ampligen®, an experimental therapeutic, in the clinical treatment of CFS patients who have a specific deficiency in Natural Killer (NK) cell activity. Immunosuppression is often seen in CFS patients and may be a feature of many retroviruses in animal and man. Phase III clinical studies have been conducted in CFS and a New Drug Application (NDA) is presently pending before the United States Food and Drug Administration (FDA).
Ampligen® (Poly I : Poly C12U), an experimental therapeutic, was in fact originally developed as a broad-spectrum antiviral/immunomodulator, and has previously demonstrated bioactivity against retroviruses in model systems.
The Company stated that an update on its CFS programs will be provided at the upcoming Health and Human Services CFS Advisory Committee in Washington, D.C. in November, 2009.