FDA authorizes clinical trial of intranasal Ampligen

Drug-maker Hemispherx Biopharma, Inc., recently received authorization from the U.S. Food and Drug Administration to begin a new clinical trial of intranasal Ampligen when used in conjunction with commercially approved seasonal influenza vaccine.

The study’s objective is to evaluate the safety of three cycles of Ampligen administered three days after administration of the nasal seasonal influenza vaccine. Researchers will also be examining the various immune responses to the trivalent influenza vaccine administered intranasally with and without Ampligen, according to

As part of the authorization, the FDA is requesting that certain protocol amendments and pre-clinical items be filed with the Investigational New Drug Application. Hemispherx announced that the FDA requests will not affect the implementation or timing of the clinical study, which will rely on the use of healthy volunteers.

Hemispherx recently received a patent from the U.S. Patent and Trademark Office to use Ampligen as an influenza virus vaccine adjuvant against pandemic avian influenza. The patent covers the method of using Ampligen intranasally with a seasonal influenza vaccine to boost the immune response against H5N1 avian influenza, according to

Intranasal vaccination stimulates mucosal immunity, which is characterized by a broader and potentially more effective immune response. The Philadelphia-based Hemispherx specializes in the development and production of intranasally administered vaccines.