Ampligen has demonstrated positive results for the treatment of Ebola in previously conducted animal studies
“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 K. Equels, M.S. J.D., Chief Executive Officer of AIM ImmunoTech. Ebola virus disease (EVD) is a rare but severe, deadly disease causing a multitude of symptoms including fever, gastrointestinal issues, aches, and bruising.1 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. The Company has conducted experiments in SARS-CoV-2 showing Ampligen has a powerful impact on viral replication. The prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against SARS-CoV-2. AIM is currently evaluating the safety and effectiveness of intravenous Ampligen 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. The Company plans to conduct an intranasal study of Ampligen to potentially enhance and expand natural immunity. The Orphan Drug Designation program provides Orphan status to drugs and biologics which are defined as those intended for the treatment, prevention or diagnosis of a rare disease or condition, which is one that affects less than 200,000 persons in the U.S. or meets certain cost recovery provisions. Orphan Drug Designation qualifies sponsors for incentives including tax credits for qualified clinical trials, exemption from user fees, and potential seven years of market exclusivity after approval.2
For more information, please visit aimimmuno.com and connect with the Company on Twitter, LinkedIn, and Facebook. 1 (October 2022). Ebola (Ebola Virus Disease). CDC centers for Disease Control and Prevention. https://www-cdc-gov.libproxy1.nus.edu.sg/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