Japan's NIID extends accord with HemiSpherx

Japan's National Institute of Infectious Diseases (NIID) has extended its relationship with USA-based Hemispherx Biopharma to initiate research on the intranasal co-administration of the former's HIV-1 vaccine with the latter's experimental TLR3 agonist and immune enhancer, Ampligen (Poly I; Poly C12U). This research takes its cue from earlier successful studies suggesting an effective role for Ampligen in boosting certain vaccines that combat the H5N1 strain of avian influenza, as well as seasonal influenza viruses.

The NIID's interest is to identify an effective and safe immune enhancer which activates a robust mucosal immune response. It hopes that Ampligen will be able to overcome the historical problem which has handicapped AIDS vaccine development worldwide, namely marginal immune response which undermines the potential of long-lasting protection. Ampligen, an experimental immunotherapeutic, will be combined with HIV recombinant protein and administered via an intranasal route. Once antibodies are produced, the NIID team will further analyze neutralizing and protective activity. Financial terms of the accord were not revealed.

Hemispherx is currently preparing a New Drug Application to be submitted to the US Food and Drug Administration for the use of Ampligen as a prospective monotherapy treatment of chronic fatigue syndrome, specifically to improve physical performance and quality of life in this severely debilitating condition, which is without a recognized therapeutic intervention in any of the world's major pharmaceutical markets.