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December 17, 2012
06:28 EDTHEBHemispherx's fatigue drug to be reviewed again by FDA, WSJ reports
A potential treatment for chronic fatigue syndrome will be reviewed again this week when an FDA panel looks at Hemispherx Biopharma's (HEB) experimental drug Ampligen, reports the Wall Street Journal. The drug has been in development for chronic fatigue syndrome for about two decades, but in 2009 the FDA refused to approve it, saying clinical studies submitted for approval of the product didn't provide "credible evidence" of the drug's effectiveness. Reference Link
News For HEB From The Last 14 Days
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January 26, 2015
08:34 EDTHEBHemispherx reports genetic changes in Ebola may impede potential treatments
Hemispherx Biopharma announced that in a new publication in the journal mBio, scientists at the U.S. Army Medical Research Institute of Infectious Disease, or USAMRIID, Harvard University, and Massachusetts Institute of Technology, or MIT, studied genetic changes in the Ebola virus, or EBOV, circulating in West Africa and concluded that genomic drift of the EBOV over time may be sufficient to block the action of otherwise potential therapies that target EBOV genetic sequences. The types of potential drugs at risk include monoclonal antibodies and small-interfering RNA which are scheduled to be evaluated during the current outbreak. The two platform drugs of Hemispherx, Alferon N and Ampligen, both experimental therapeutics in a setting of Ebola disease, have recently both demonstrated anti-EBOV activity and have mechanisms of action which are multifaceted by working through cellular "molecular cascades" rather than by targeting viral protein or genetic sequences whose specificity is vulnerable to mutational change as reported by the research consortium on January 20. Although none of the experimental drugs have been approved by the FDA, certain of the experimental therapeutics discussed in the USAMRIID/Harvard/MIT report, are being used to treat small numbers of patients under a World Health Organization, or WHO, emergency protocol. The potential impact of genomic drift on development of therapeutics for EBOV disease has already been realized for other pathogenic human virus, such as HIV and influenza. The large genetic and antigenic diversity seen in HIV has been a "major stumbling block" for development of preventative vaccines.

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