AIM ImmunoTech Inc. announced a late-breaking presentation at the 36th International Conference on Antiviral Research (ICAR) detailing Ampligen's mechanism of action in the treatment of Ebola virus disease (EVD). The presentation was given by Angela Corona, PhD, Department of Life and Environmental Sciences, University of Cagliari, Monserrato, Italy, and one of the published authors of a recent manuscript titled "Ebola virus disease: In vivo protection provided by the PAMP restricted TLR3 agonist rintatolimod and its mechanism of action." Ebola virus (EBOV) is a highly infectious and lethal pathogen responsible for sporadic, self-limiting clusters of EVD in Central Africa capable of reaching epidemic status. Highlights of the recently published Ampligen data that was presented include: As a TLR3 agonist, Ampligen induces and enhances innate immunological responses to EBOV infection.

Ampligen appears to inactivate the EBOV lethal factor (EBOV VP35), which is believed to be responsible, in part, for the high mortality rate observed in humans, by acting as a "competitive decoy." VP35 is understood to sequester the dsRNA produced by EBOV during its replication, which inhibits the normal innate immune responses to viral infection. Ampligen protected mice from a lethal challenge by mouse adapted EBOV-Zaire and its associated weight loss. The 6 mg/kg doses, frequently used in AIM's clinical trials, used in mouse model is easily achievable and well tolerated in humans.

Overall, the data suggest Ampligen's potential as a viable candidate to protect against exposure to EBOV. The corresponding slides from the presentation at ICAR are now available on the Company's website (aimimmuno.com) on the "Events and Presentations" page. Ampligen has been granted Orphan Drug status for Ebola virus disease by the European Medicines Agency and the FDA.

Ampligen is not currently approved for the prevention or treatment of EVD. The company intends to file Investigational New Drug applications to study the use of Ampligen (1) as an early onset therapy for the treatment of EBOV, and (2) for the prevention of Ebola virus reactivation. Ultimately, the Company's goal is to seek a Tropical Disease Priority Review Voucher for new drug applications associated with these indications.