In in vitro studies, Ampligen was combined with the neuraminidase inhibitors oseltamivir (brand name Tamiflu) and zanamivir (Relenza) and thereafter applied to cells in culture infected with an H5N1 strain of highly pathogenic avian influenza (HPAI). Three days following infection, cell viability and synergy analyses were performed.
Both Ampligen and the neuraminidase inhibitors exhibited dose responses in the inhibition of the adverse effects of HPAI on cell cultures. Moreover, the combination of Ampligen with oseltamivir at doses exceeding a certain threshold showed synergistic inhibition of viral induced cell destruction, and similar synergistic results were seen with the combination of Ampligen with zanamivir.
While it is widely recognized that HPAI is a major, global public health concern, existing antiviral monotherapies can rapidly lead to drug-resistant strains of virus. The Hemispherx study was conducted to establish a potentially pivotal role for Ampligen as part of a potentially effective combination therapy as the experimental therapeutic exhibits antiviral activity by different mechanisms than either Tamiflu or Relenza.
Ampligen has already completed phase III clinical testing for chronic fatigue syndrome.