Ampligen is currently being evaluated for the safety and effectiveness to reduce replication of SARS-CoV-2 virus from upper airway in patients in an ongoing Phase 1/2 study for the treatment of COVID-19 cancer patients.”ĪIM ImmunoTech Inc. The prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against SARS-CoV-2. We have conducted laboratory experiments in SARS-CoV-2 showing Ampligen has a powerful impact on viral replication. Previous animal studies yielded positive results utilizing Ampligen in Western Equine Encephalitis Virus, Ebola, Vaccinia Virus (which is used in the manufacture of smallpox vaccine) and SARS-CoV-1. Intranasal administration of Ampligen could induce an innate mucosal immune response, thereby inhibiting respiratory viruses at the point of entry. Strayer, M.D., AIM’s Chief Scientific & Medical Officer, stated: “Ampligen, AIM’s synthetic double-stranded RNA (Poly I:Poly C12U), is a Toll-like receptor 3 (TLR3) agonist, inducing type-I interferons. A total of 40 adult subjects were enrolled in the study.ĭavid R. Mucosal immune cells (granulocytes, monocytes, dendritic cells, NK-cells, T-cells and B-cells) were characterized using spectral flow cytometry. Type I interferons (IFN-α, IFN-β), NFκB-mediated cytokines (IFN-g, IL-6, IL-8, TNF) and chemokines (CXCL10, RANTES, MCP-1) were measured. To characterize the mucosal immune response, nasal mucosal samples were obtained frequently, especially around first and last dose (pre-dose, 3h, 6h, 24h and 48h post-dose). Safety and tolerability were monitored for 28 days after first dosing. In a randomized, double-blind, placebo-controlled, dose-escalation study, Ampligen (75µg, 200µg, 500µg, 1250µg) or placebo (4:1) was administered in both nostrils every other day, for a total of 7 consecutive doses. These Phase 1 data, in combination with the prior promising results of in vitro modelling which demonstrated that Ampligen could decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels, continue to be encouraging as we advance the development of Ampligen as a potential intranasal prophylactic approach to prevent infection and spread of COVID-19.” The repeated intranasal dosing regimen was shown to be well tolerated in all tested dose levels. Equels stated: “The results from this Phase 1 study evaluating intranasal Ampligen in healthy subjects support the promising potential in the ability of Ampligen to inhibit respiratory viruses at the point of entry. The presented poster is available to view on the Events & Presentations page of the Company’s website.ĪIM Chief Executive Officer Thomas K. MCP-1 and RANTES - which are important immunomodulators - peaked 3-24 hours after administration, mainly for 500 μg AmpligenĪt doses evaluated, intranasal Ampligen administration did not drive a significant change in nasal immune cell abundance Solicited local AEs were comparable across all treatment groups and placeboĪn increase in IL-6, IL-8, and TNF production was observed for both Ampligen and placebo after dosing Repeated intranasal administration of Ampligen was well tolerated.
The data showed positive safety, tolerability and biological activity of a 13-day dosing regimen conducted in Q2 2021 for intranasal Ampligen® (rintatolimod) in healthy subjects. Smidt - Centre for Human Drug Research (CHDR), Leiden, the Netherlands in a poster titled, “ Safety, tolerability and biological activity of repeated intranasal administration of TLR3 agonist Ampligen (Poly I:Poly C12U) in healthy subjects,” at the British Society for Immunology Congress 2022. (NYSE American: AIM) (“AIM” or the “Company”), 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, today reported that data were recently presented by Lisanne C.A. 08, 2022 (GLOBE NEWSWIRE) - AIM ImmunoTech Inc. Intranasal administration of Ampligen demonstrated to be well-toleratedīased on data generated to date, Ampligen could have potential as a prophylactic or early treatment against respiratory viral infectionsĭata presented in poster presentation at the British Society for Immunology Congress 2022
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