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Hemispherx Announces Initial Test Results In Biosecurity/Biodefense Arena

PHILADELPHIA, Sept. 12, 2013 (GLOBE NEWSWIRE) -- Chairman and CEO, William A. Carter, M.D. of Hemispherx Biopharma (NYSE MKT:HEB) announced at the Rodman and Renshaw Conference in New York City, NY on September 9, 2013, a major new initiative in the BioSecurity field involving both Alferon N Injection ® and Ampligen ®. Alferon N Injection ® is a multi-species, natural interferon; the only natural interferon approved for sale in the U.S. Ampligen ® is a dsRNA experimental therapeutic that acts as a TLR 3 activator.

Dr. Carter highlighted the broad anti-viral effect of both drugs/biologics. The Company's strategy includes plans to undertake major programs in the biosecurity field, specifically with respect to the potential prevention or treatment of pandemic flu virus, H7N9, MERS (Middle East Respiratory Syndrome) and alpha viruses such as VEE (Venezuelan Equine Encephalomyelitis). With all three classes of viruses, researchers have now confirmed significant bioactivity with Ampligen ® or Alferon N Injection ®, or both, in either in vitro and/or in vivo non-human studies. Alferon N Injection ® has been found to be highly active against SARS virus (a close relative of MERS) by the Singapore Genome Institute in laboratory studies.

Dr. Carter highlighted the work that was recently presented at the Options for the Control of Influenza VIII Conference in Cape Town, South Africa, September, 5-10, 2013 by Professor Dr. Juergen A. Richt, DVM, Ph.D., Director of the U.S. Department of Homeland Security Center of Excellence for Emerging and Zoonotic Animal Diseases (CEEZAD). The Cape Town presentations described the results with Alferon ®, including in-vitro experiments directed against inhibiting the Tamiflu ®-resistant H7N9 pandemic influenza strain. Tamiflu ® (oseltamivir) and Alferon ® were tested in A549 cells for antiviral activity in vitro against the wild-type (wt) human A(H7N9) isolate A/Anhui/1/2013 (wt Anhui 1) and a patient isolate (A/Shanghai/1/2013 (NA-292K; Shanghai 1-NA292K) with resistance to oseltamivir. The wt Anhui 1 was sensitive to both Tamiflu ® and Alferon ®. The Shanghai 1-NA292K virus was resistant to Tamiflu ® treatment but was sensitive to Alferon ® when tested in A549 cells.

The results of the recent Kansas State University experiments, coupled with Dr. Richt's work on reassortment and other published studies, sets the stage for evaluating the possibility that mutational changes and reassortment could be prevented in animals by the use of type I interferon and/or a type I interferon inducer. These laboratory results to date suggest that Alferon ® may be a promising candidate to treat the virulent and potentially lethal Tamiflu ®-resistant H7N9 virus in animals and humans. Moreover, previous research suggests that Alferon ® may be active against a range of viruses existing in animal populations even in the low dose oral (LDO) formulation referred to as Alferon ® LDO.

Dr. Carter highlighted the collaborations between Hemispherx and leading institutions in the BioSecurity field on both the Alferon ® and Ampligen ® platforms, such as U.S. Department of Homeland Security Center of Excellence for Emerging and Zoonotic Animal Diseases (CEEZAD), Kansas State University, College of Veterinary Medicine; Institute for Antiviral Research, Utah State University; Center of Biodefense and Emerging Disease, University of Texas Medical Branch; Preclinical Drug Development, Lovelace Respiratory Research Institute; Hokkaido University, Japan OIE World Reference Laboratory, Hokkaido Department of Disease Control, School of Veterinary Medicine, Research Center for Zoonosis Control; and University of Alabama Clinical Research Unit.

In April of 2012, Hemispherx announced that Ampligen®, an experimental immunotherapeutic, has been nasally administered in conjunction with FluMist® to healthy human volunteers in a study being conducted at the University of Alabama at Birmingham under the auspices of Dr. Paul Goepfert, Associate Professor of Medicine in the Division of Infectious Diseases and Director of the Alabama Vaccine Research Clinic. The objective is to determine the extent to which Ampligen® may mobilize potential protections against pandemic influenza when used in conjunction with a seasonal flu vaccine; even against mutated strains of flu virus.

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