AIM ImmunoTech Inc (NYSEAMERICAN:AIM) said Tuesday it had received Institutional Review Board (IRB) approval to widen the clinical trial for its drug candidate Ampligen to people suffering from long-term effects of the coronavirus (COVID-19).
The group, known as COVID-19 ‘long haulers’ because they continue to show chronic fatigue-like symptoms for months after officially recovering from their initial illness, will be included in the clinical trial for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).
Up to 20 of the 100 active participants can be long haulers, according to the new trial protocol amendment, Florida-based AIM told investors. The firm is now preparing the IRB-approved protocol for submission to the US Food and Drug Administration.
Ampligen (rintatolimod) is an experimental ribonucleic acid that is in clinical trials to address both chronic fatigue syndrome and to treat multiple cancers. The firm is exploring its use in treating COVID-19 and so far, results are promising. In August, AIM revealed Ampligen was able to decrease the infectious viral yield of SARS-SoV-2, the virus that causes COVID-19, by 90% in a recent in vitro model.
In June, the pharmaceutical firm filed a provisional utility patent application for Ampligen to be used as a possible treatment for chronic fatigue associated with COVID-19.
Charles Lapp, MD and a global expert in ME/CFS, expressed hope in a statement that Ampligen might have a role to play in helping long haulers overcome chronic fatigue.
"It is anticipated that COVID-19 will trigger a large number of CFS cases, providing an opportunity for the medical community to learn more about the onset and pathogenesis of CFS,” Lapp told investors.
Updates on Japan efforts
Separately, AIM updated shareholders on its progress in Japan, where it is working with Shionogi & Co Ltd and the country’s National Institute of Infectious Diseases on potentially using Ampligen as part of a COVID-19 vaccine.
The company said The Japan Agency for Medical Research and Development has expressed support for efforts in a recent publication. AIM has completed two shipments of Ampligen to Japan, which were received by the NIID and Shionogi respectively.
AIM is focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers.
--Updated with information on Japan shipments--
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