Ampligen® (rintatolimod) is an immuno-modulator with broad spectrum exercise presently being evaluated for the remedy of worldwide essential cancers, viral illnesses and problems of the immune system
Ampligen has demonstrated optimistic outcomes for the remedy of Ebola in beforehand carried out animal research
OCALA, Fla., Nov. 02, 2022 (GLOBE NEWSWIRE) — AIM ImmunoTech Inc. (NYSE: American AIM) (“AIM” or the “Company”), an immuno-pharma firm targeted on the analysis and improvement of therapeutics to deal with a number of varieties of cancers, immune problems, and viral illnesses, together with COVID-19, the illness attributable to the SARS-CoV-2 virus, immediately introduced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Ampligen® (rintatolimod) for the remedy of Ebola virus illness.
Ampligen is AIM’s dsRNA product candidate being developed for globally essential cancers, viral illnesses and problems of the immune system.
“Receiving Orphan Drug Designation for Ampligen for the treatment of Ebola from the FDA is a testament to the depth and breadth of the potential with Ampligen. We continue to be encouraged by the promising results Ampligen has demonstrated to date across a number of indications where there remains significant unmet need. While Ebola is not a primary focus for the Company at the moment, this provides further validation as well as optionality as we determine the next steps for this program moving forward,” commented Thomas Okay. Equels, M.S. J.D., Chief Executive Officer of AIM ImmunoTech.
Ebola virus illness (EVD) is a uncommon however extreme, lethal illness inflicting a mess of signs together with fever, gastrointestinal points, aches, and bruising.1 Previous animal research yielded optimistic outcomes using Ampligen in Western Equine Encephalitis Virus, Ebola, Vaccinia Virus (which is used within the manufacture of smallpox vaccine) and SARS-CoV-1. The Company has carried out experiments in SARS-CoV-2 displaying Ampligen has a strong affect on viral replication. The prior research of Ampligen in SARS-CoV-1 animal experimentation might predict comparable protecting results towards SARS-CoV-2. AIM is presently evaluating the security and effectiveness of intravenous Ampligen to scale back replication of SARS-CoV-2 virus from higher airway in sufferers in an ongoing Phase 1/2 examine for the remedy of COVID-19 most cancers sufferers. The Company plans to conduct an intranasal examine of Ampligen to doubtlessly improve and broaden pure immunity.
The Orphan Drug Designation program offers Orphan standing to medicine and biologics that are outlined as these meant for the remedy, prevention or prognosis of a uncommon illness or situation, which is one which impacts lower than 200,000 individuals within the U.S. or meets sure price restoration provisions. Orphan Drug Designation qualifies sponsors for incentives together with tax credit for certified medical trials, exemption from consumer charges, and potential seven years of market exclusivity after approval.2
About AIM ImmunoTech Inc.
AIM ImmunoTech Inc. is an immuno-pharma firm targeted on the analysis and improvement of therapeutics to deal with a number of varieties of cancers, immune problems, and viral illnesses, together with COVID-19. The Company’s lead product, Ampligen® (rintatolimod) is an immuno-modulator with broad spectrum exercise being developed for globally essential cancers, viral illnesses and problems of the immune system.
Ampligen is presently getting used as a monotherapy to deal with pancreatic most cancers sufferers in an Early Access Program (EAP) accepted by the Inspectorate of Healthcare within the Netherlands at Erasmus Medical Center and AIM has commenced a Phase 2 medical examine in 2022. The Company additionally has a number of ongoing medical trials to judge Ampligen as a combinational remedy for the remedy of a wide range of stable tumor sorts each underway and deliberate at main most cancers analysis facilities. Additionally, Ampligen is accepted in Argentina for the remedy of extreme power fatigue syndrome (CFS) and is presently being evaluated in lots of elements of SARS-CoV-2/COVID-19 myalgic encephalomyelitis/power fatigue syndrome (ME/CFS) and Post COVID Conditions.
For extra data, please go to aimimmuno.com and join with the Company on Twitter, LinkedIn, and Facebook.
1 (October 2022). Ebola (Ebola Virus Disease). CDC facilities for Disease Control and Prevention. https://www.cdc.gov/vhf/ebola/index.html
2 (May 2022). Developing Products for Rare Diseases & Conditions. U.S. Food and Drug Administration. https://www.fda.gov/industry/developing-products-rare-diseases-conditions
