AIM ImmunoTech Receives Orphan Drug Designation for Ampligen (rintatolimod) for the Treatment of Ebola Virus Disease

2022-11-02

Ampligen® (rintatolimod) is an immuno-modulator with broad spectrum activity currently being evaluated for the treatment of globally important cancers, viral diseases and disorders of the immune system

Ampligen has demonstrated positive results for the treatment of Ebola in previously conducted animal studies

OCALA, Fla., Nov. 02, 2022 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (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 announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Ampligen® (rintatolimod) for the treatment of Ebola virus disease.

Ampligen is AIM’s dsRNA product candidate being developed for globally important cancers, viral diseases and disorders 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 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

About AIM ImmunoTech Inc.

AIM ImmunoTech Inc. 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 Company’s lead product, Ampligen® (rintatolimod) is an immuno-modulator with broad spectrum activity being developed for globally important cancers, viral diseases and disorders of the immune system.

Ampligen is currently being used as a monotherapy to treat pancreatic cancer patients in an Early Access Program (EAP) approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center and AIM has commenced a Phase 2 clinical study in 2022. The Company also has multiple ongoing clinical trials to evaluate Ampligen as a combinational therapy for the treatment of a variety of solid tumor types both underway and planned at major cancer research centers. Additionally, Ampligen is approved in Argentina for the treatment of severe chronic fatigue syndrome (CFS) and is currently being evaluated in many aspects of SARS-CoV-2/COVID-19 myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and Post COVID Conditions.

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/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