FDA Authorizes New Hemispherx Biopharma Clinical Trial of Intranasal Ampligen(R) With Seasonal Influenza Vaccine
First Clinical Application of Ampligen(R) Intranasally
Jul 20, 2011 7:00:00 AM
2011 GlobeNewswire, Inc.
PHILADELPHIA, July 20, 2011 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company" or "Hemispherx") today announced it has received U.S. Food Drug Administration (FDA) authorization to proceed with the initiation of a new clinical trial of intranasal Ampligen® [rintatolimod; poly(I)·poly(C12,U)] used in conjunction with commercially approved seasonal influenza vaccine. The FDA authorization also requests that certain protocol amendments and pre-clinical items be filed to the Investigational New Drug (IND) Application; these requests are not expected to affect the implementation or timing of the clinical study which will involve healthy volunteers. The primary objective of this study is to evaluate the safety of three cycles of intranasal Ampligen® administered three days following each intranasal dose of seasonal influenza vaccine. Other objectives include evaluation of various immune responses to the trivalent seasonal influenza vaccine administered intranasally with and without Ampligen®. Ampligen®, a toll-like receptor 3 (TLR3) agonist, is an experimental therapeutic in advanced clinical development for the potential treatment of Chronic Fatigue Syndrome (CFS), an enigmatic disorder which may have certain viral "footprints".
The initial studies for the influenza application were conducted at the Japanese National Institutes of Health (JNIH) and resulted in a series of peer-reviewed articles in the infectious diseases medical literature over the last several years.
A similar study of Ampligen® and a seasonal influenza vaccine in mice resulted in cross-protection of the mice against a pandemic form of avian influenza (H5N1). Evidence for cross-reactivity against pandemic forms of avian H5N1 influenza virus will be investigated as one of the objectives of this study. One goal of this approach is to generate protective mucosal immunity against newly emerging strains of H5N1 with pandemic potential using Ampligen® as a mucosal adjuvant with trivalent seasonal influenza vaccine.
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