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October 10, 2000
Ampligen has been cleared for the first stage of regulatory review for the potential treatment of chronic fatigue syndrome (CFS) in the European Union.
Ampligen is an actively anti-viral compound that stops virus replication. In several studies, it has been shown to boost immunity and restore cognitive functioning. It is currently approved for Phase 3 clinical testing in the U.S. and is available by prescription in Canada, although the intravenous treatment is quite expensive.
The centralized regulatory authority of the European Union officially notified the makers of the drug, Hemispherx Biopharma, Inc., last week that its file has been fully validated. Validation is the official regulatory designation that the extensive clinical and other data analysis submitted upon comprehensive review fully meets the statutory standards. Validation by the London based central committee permits the review process of the Hemispherx Europe application to proceed to the advanced stage.
Hemispherx is a biopharmaceutical company with worldwide programs to develop clinically nucleic acid medicinal products, a new class of potential medicines for chronic viral immune disorders. It is estimated that a significant number of people in the EU and US may suffer from CFS for which no other approved medicines are presently available.
Ampligen®, the only investigational treatment worldwide at the phase 3 clinical development level, is presently available under certain “treatment IND” provisions to severely debilitated patients in North America, Europe, Australia, and Africa.
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Clearing the Fog: Coping with the Cognitive Dysfunction of Fibromyalgia & Chronic Fatigue Syndrome [more]
Chocolate's Potential Health Benefits – and its Effect on Chronic Fatigue Syndrome Patients [more]
What Is Wrong with Artificial Sweeteners? [more]
USDA Food Guide Pyramid [more]
Flu Shot Pros & Cons [more]
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