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News Breaks
February 4, 2013
19:39 EDTHEBFDA declines to approve Hemispherx's Ampligen new drug application
Hemispherx Biopharma announced that it received a complete response letter from the US Food and Drug Administration declining to approve its new drug application for Ampligen for Chronic Fatigue Syndrome. The FDA said Hemispherx should conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analyses. In its complete response letter, the FDA set forth the reasons for this action and provided recommendations to address certain of the outstanding issues. The agency stated that the submitted data do not provide substantial evidence of efficacy of Ampligen for the treatment of CFS and that the data do not provide sufficient information to determine whether the product is safe for use in CFS due to the limited size of the safety database and multiple discrepancies within the submitted data. Hemispherx plans to request an end-of-review conference with the FDA as a precursor to submitting a formal appeal to the office of new drugs in the FDA's center for drug evaluation and research regarding the agency's decision
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September 29, 2014
08:35 EDTHEBHemispherx expands research on potential Ebola treatments
Hemispherx Biopharma announced a widened set of research collaborations designed to develop therapeutic cocktails against Ebola which may potentially overcome the emergence of drug resistance due to Ebola virus mutation. The rapid acquisition of Ebola virus, or EBOV, sequence variation has been recently demonstrated during genomic surveillance of the current Ebola virus disease, or EVD. This observed genomic sequence variation suggests drugs that target specific viral non-variant protein sequences are at risk of mutation mediated activity failure. This complicates significantly the development of EBOV inhibitors in the drug development pipeline, some of which have been highly effective in treating advanced EVD in non-human primates. The two platform drugs of Hemispherx, Alferon N and Ampligen, have certain unique structural attributes and developmental histories which suggest potential incremental value with respect to inclusion in various Ebola therapeutic cocktails under development. First, both drugs have mechanisms of action, which are multifaceted by working thru cellular "molecular cascades" rather than target viral targets whose specificity is vulnerable to mutational change.
September 22, 2014
08:49 EDTHEBHemispherx announces Alferon LDO primate research peer-reviewed publication
Hemispherx Biopharma announced a peer-reviewed publication entitled "Protection from Pulmonary Tissue Damage Associated with Infection of Cynomolgus Macaques by Highly Pathogenic Avian Influenza Virus by Low Dose Natural Human IFN- Administered to the Buccal Mucosa" in the current issue of Antiviral Research 2014. This publication is a collaborative project conducted at Viroclinics Biosciences BV, Rotterdam, an internationally recognized research facility for the study of influenza viruses. The biohazard laboratories are directed by Prof. Albert D. M. E. Osterhaus, an internationally known virologist specializing in the study of pandemic influenza. Highly pathogenic avian influenza A virus is endemic in wild birds in Asia and the Middle East, causing disease and transmissibility in domestic poultry. Infection of humans with H5N1 is associated with a high mortality rate due to an alveolar destructive primary viral pneumonia frequently expressed clinically as acute respiratory distress syndrome.

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