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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 15, 2014
08:44 EDTHEBHemispherx Ampligen induces cross-reactive antibody formation
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September 10, 2014
08:35 EDTHEBHemispherx expands Ebola collaborative research agreement with governments
Hemispherx Biopharma announced that it expanded its Collaborative Research Agreement to test Alferon, the only multi-species, natural alpha interferon, or IFN, commercially approved in the U.S. and Ampligen®, an experimental drug, to be evaluated against the deadly Ebola virus also under the DEA, or Data Exchange Agreement, Annex for Medical Preparedness and Bio-Defense Agreement between the Swiss Surgeon General and the US Department of Defense. The World Health Organization has warned that "The Ebola outbreak will affect more than 20,000 people in West Africa and might spread to more countries, indicating a clinical emergency all over the world."
September 8, 2014
08:43 EDTHEBHemispherx, USAMRIID to collaborate in studying Alferon, Ampligen
Hemispherx Biopharma announced that the company and United States Army Medical Research Institute of Infectious Diseases, or USAMRIID, scientists have agreed to test Alferon, the only multi-species, natural alpha interferon, or IFN, commercially approved in the U.S. and Ampligen, an experimental drug, to be evaluated against the deadly Ebola virus, which has been and remains a major focus of efforts at USAMRIID, a unit of the Department of Defense responsible for medical biological defense research. A key component of innate immune responses is activation of the Toll-like receptors, or TLRs. TLR3 activation by dsRNA is an essential response element to viral infection. Block TLR3 activation and an essential element of the innate immune response is disarmed. Ampligen, Poly I:Poly C12U was designed as an IFN inducer and has demonstrated antiviral activity in a wide variety of DNA and RNA viruses in pre-clinical testing. Replenishing an Ebola patient's natural interferon with Alferon and restoring that patient's innate immune response by Ampligen's overcoming the Ebola blocking mechanisms could potentially reduce the morbidity and mortality of Ebola virus disease.

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