Hemispherx Biopharma has announced that a safety study of Ampligen plus FluMist in 25 healthy volunteers showed that intranasal Ampligen was generally well tolerated.
Ampligen is a TLR-3 agonist, which the company is already developing for the treatment of chronic fatigue syndrome and for solid tumors. In previous studies of Ampligen for those indications, the drug had been delivered intravenously.
Hemispherx CEO Thomas Equels said, “We’re very encouraged by the outcome of this study, establishing a foundation for Ampligen as an intranasal adjuvant. This shows Ampligen’s potential to take us to the next step of developing Ampligen either as a strain-specific or more universal influenza intranasal vaccine immune enhancing adjuvant. This safety study was the first milestone to our ultimate goal, which is to combine Ampligen with a non-live virus vaccine to produce stronger and broader coverage and to confer longer immunity than is possible with the vaccine alone. I firmly believe that Ampligen’s multi-faceted impact on the immune system redefines the term adjuvant.”
Equels added, “Our next milestone for intranasal Ampligen is to collaborate with an established vaccine maker to administer Ampligen intranasally with a non-live virus vaccine. This next milestone will allow us to determine Ampligen’s clinical efficacy as a viral vaccine adjuvant and to evaluate it as a mechanism for providing cross protection from virus mutations as well as other forms of the virus. We have every expectation of results similar to the prior animal studies.”
Read the Hemispherx Biopharma press release.
