AIM ImmunoTech Inc announced that all subjects have completed treatment in the Phase 1 clinical study to assess the safety, tolerability, and biological activity of its flagship drug Ampligen as a potential intranasal therapy.
A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with the Ampligen given at four escalating dosages across four cohorts, to a maximum level of 1,250 micrograms. The study reported no severe adverse events at any dosage level.
Ampligen has already been featured in a publication containing state-of-the-art methodologies in the peer-reviewed medical journal “Cancers” as a potential treatment option for cancer patients infected with SARS-CoV-2. The study’s authors stated that Ampligen has the potential to reduce the severity of the coronavirus (COVID-19), which has so far caused more than 3.7 million deaths globally. Unlike other drugs tailored to combat specific diseases, AIM said Ampligen targets and amplifies the natural immune system pathways that fight viruses.
“With these positive preliminary results in hand, the company is now moving forward with the initial planning and negotiations for a follow-up Phase 2 study testing Ampligen as a potential broad-spectrum respiratory virus prophylaxis,” AIM said in a statement.
“This Phase 2 study will test this proposition in humans. A successful Phase 2 study could also establish Ampligen as a potential prophylaxis against future viral variants and future novel respiratory viruses for which there are no current therapies.”
AIM said an Ampligen prophylaxis could potentially benefit vulnerable populations who are at increased risk of transmission due to their environments, such as hospital workers; people on cruises, cargo or military ships; people on commercial airplanes; and service personnel in close quarters on military installations.
AIM is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.