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FDA Authorizes Expansion Of Ampligen/FluMist Intranasal Clinical Trial Designed To Elicit Potential Protection Against Many Pre-Pandemic Influenza Viruses

PHILADELPHIA, Dec. 9, 2013 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the "Company" or "Hemispherx") today announced that its Phase 1/2 clinical trial at the University of Alabama Vaccine Research Clinic is now being expanded based on an analysis of safety results to date conducted by both the Food and Drug Administration ("FDA") and a Data Monitoring Committee, the latter group comprised of a team of independent clinical, basic research, and statistical professionals.

The ongoing clinical study is the first extension to humans of preclinical studies, previously published in the peer-reviewed literature, indicating that the combination of Ampligen® (an experimental therapeutic) with commercially available seasonal influenza vaccine when applied intranasally, may provide enhanced protection against certain potentially pandemic influenza strains (Ichinohe T, et al. 2007, JID 196:1313-1320).

The Spanish flu pandemic killed between 20 and 100 million people in 1918-1919, a similar epidemic based on the worldwide population in 2004 has been estimated to result in approximately 60 million deaths (Murray CJ, et al. 2006, Lancet 368:2211-2218). Influenza often leads to death in patients suffering from underlying diseases; complications are especially prevalent in the elderly population. Hence, the objective of identification of an influenza vaccine and/or vaccine adjuvant "cocktail" offering broad-spectrum protective properties (sometimes referred to as a "Universal flu vaccine"), remains one of the highest public health priorities. Successful animal experimentation does not necessarily predict clinical effectiveness and no assurance can be given that the projected clinical tests will demonstrate either acceptable safety or efficacy.

The pioneering preclinical influenza research was conducted over several years at the Japanese National Institutes of Health (JNIH) under the direction of Dr. Hideki Hasegawa, Director, Department of Pathology. The research was conducted under a standard Material Transfer Agreement with the Company, and Dr. Hasegawa was an independent investigator who received no financial support from Hemispherx for his experimental work.

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