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FDA approves expansion of clinical trials aimed at preventing flu pandemic

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The FDA has authorized the expansion of Hemispherx Biopharma,
Inc.’s Phase 1/2 Ampligen/FluMist Intranasal clinical trial studies indicating that combining Ampligen(R) (an experimental therapeutic) with commercially available seasonal
influenza vaccine may provide enhanced protection against certain potentially pandemic influenza strains.
Influenza often leads to death, particularly among patients suffering from underlying diseases. Complications are also extremely prevalent in the elderly population.

The first stage was given FDA authorization April 30, 2012, with the hope of preventing a repeat of the Spanish flu pandemic, which killed between 20 and 100 million people in 1918-1919. A similar epidemic (caused by new strains, including the H5N1 and H7N9 bird flus, etc.) based on the worldwide population in 2004 has been estimated to result in approximately 60 million deaths.

According to Dr. Goepfert, Associate Professor of Medicine in the Division of Infectious Diseases and Director of the Alabama Vaccine Research Clinic, "the normal route of transmission of the flu virus is through the nasal passage. We are excited about beginning this study, which utilizes the mucosal immune system and thus offers significant potential to protect large numbers of individuals by administering enhanced flu vaccines.
The pioneering pre-clinical 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. Dr. Hasegawa showed that Ampligen(R) helped to expand viral epitope recognition and thereby provided cross-protection to flu virus strains which were not expected to be conveyed by the administered vaccine."

Hemispherx believes that the expanded human trial at the University of Alabama will “provide the first data in humans as to whether the epitope expansion observed by Dr. Hasegawa in experimental animals occurs in humans.” However, representatives of the company stressed, “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 above 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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