AIM ImmunoTech Receives Orphan Drug Designation for Ampligen (rintatolimod) for the Treatment of Ebola Virus Disease
November 02 2022 - 7:05AM
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
Investor Relations Contact
JTC Team, LLC
Jenene Thomas
833-475-8247
AIM@jtcir.com
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