Previously published Biosafety Level 4 pre-clinical study showed 100% survival with early treatment following infection in a mouse model following lethal doses of Ebola
Company to release Virtual Investor “Ebola: What This Means” Segment on June 4th at 9:00 AM ET
OCALA, Fla., May 27, 2026 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”), an immuno-pharma company focused on the development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, today announced it will release an on-demand video presentation detailing important previously published pre-clinical findings supporting the potential role of its lead drug Ampligen® (rintatolimod) as a prophylactic and/or an early-onset antiviral treatment for Ebola virus disease (EVD).
The Virtual Investor “Ebola: What This Means” Segment will be accessible here on Thursday, June 4, 2026 at 9:00 AM ET.
The announcement comes amid mounting international concern surrounding the rapidly evolving Ebola outbreak involving the Bundibugyo strain (BDBV) currently spreading in parts of Central and East Africa. The World Health Organization (WHO) has declared the outbreak a Public Health Emergency of International Concern (PHEIC), underscoring the growing urgency for effective countermeasures against Ebola, including the current BDBV strain for which there is currently no approved specific treatment or vaccine.
With global public health authorities warning of increased cross-border transmission risk, health care systems and biodefense agencies are actively evaluating scalable antiviral and immune-based therapeutic strategies capable of responding to emerging viral threats.
AIM believes the previously published research conducted at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) Biosafety Level 4 laboratories highlights Ampligen’s potential to address this critical unmet medical need.
The peer-reviewed study, titled “Ebola virus disease: In vivo protection provided by the PAMP restricted TLR3 agonist rintatolimod and its mechanism of action,” reported several important findings that suggest Ampligen’s potential utility as a preventive and/or as an early-intervention antiviral therapeutic, including:
- Ampligen offers 100% protection against Ebola virus with early administration following infection in a mouse model that is otherwise 100% lethal to the mice
- Protection from Ebola in mice was achieved at a dose of 6 mg/kg
- Ampligen is generally well-tolerated in humans at doses of 6 mg/kg
- Ampligen blocks EBOV VP35 viral dsRNA binding and is not a RIG-1-like agonist
- Ampligen acts as a PAMP restricted agonist for direct TLR3 activation
“In vivo pre-clinical analysis performed at the United States Army Medical Research Institute of Infectious Diseases Biosafety Level 4 laboratories suggests that Ampligen has potential as a prophylactic and/or as an early-onset therapeutic in Ebola virus disease,” said AIM CEO Thomas K. Equels.
“The research demonstrated 100% protective survival, compared to 100% mortality in the lethal Ebola virus disease model. We believe these findings are especially relevant given the current Bundibugyo outbreak, which currently lacks an approved targeted therapeutic option. Ampligen’s mechanism of action – as set forth in the peer-reviewed medical journal – may position it as a potentially important countermeasure to help protect health care workers and other vulnerable populations both before and shortly after exposure.”
Mr. Equels added, “As global health authorities intensify efforts to contain the BDBV outbreak and prepare for future viral threats, we believe Ampligen’s previously demonstrated antiviral and immune-modulating properties could attract significant interest from international health organizations, biodefense agencies, and potential strategic partners. We also believe the current outbreak environment may create important opportunities for additional Biosafety Level 4 research access, collaborations and regulatory engagement in the development of Ampligen as a therapeutic for Ebola virus disease.”
Ampligen has previously received Orphan Drug designation for EVD from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
The Company’s upcoming presentation will review Ampligen’s mechanism of action, pre-clinical Ebola findings, and potential development pathways in emerging viral disease preparedness and response initiatives.
About AIM ImmunoTech Inc.
AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of its lead product, Ampligen® (rintatolimod), for the treatment of late-stage pancreatic cancer, a lethal and unmet global health problem. Ampligen is a dsRNA and highly selective TLR3 agonist immuno-modulator that has shown broad-spectrum activity in clinical trials.
For more information, please visit aimimmuno.com and connect with the Company on X, LinkedIn, and Facebook.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to be covered by the safe harbor created by those sections. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. All forward-looking statements set forth in this press release speak only as of the date hereof. Such forward-looking statements include, but are not limited to, statements relating to: potentially attracting significant interest from international health organizations, biodefense agencies, and potential strategic partners; possibly creating important opportunities for additional Biosafety Level 4 research access, collaborations, and regulatory engagement in the development of Ampligen as a therapeutic for EVD; the potential of Ampligen’s mechanism of action as a prophylactic or early-onset treatment for EVD; the timing of commencement, enrollment, completion, and results of clinical trials; intellectual property expansion and regulatory progress; the potential for Biosafety Level 4 access and approval opportunities; and timing for receiving government approvals, if at all. For all forward-looking statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. All statements in this press release other than statements of historical fact, including statements regarding the potential of Ampligen’s mechanism of action, anticipated regulatory milestones, our future results of operations and financial position, our business strategy and plans, and our objectives for future operations, are forward-looking statements. Words such as “believe,” “may,” “might,” “will,” “could,” “should,” “can,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “envision,” “potential,” “possible,” “seek,” “plan,” “project,” and similar expressions are intended to identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based upon the Company’s current expectations, estimates, assumptions, and beliefs concerning future events and conditions, which are subject to change. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof, except as required by applicable law. The Company is in various stages of seeking to determine whether Ampligen will be effective in the treatment of multiple types of viral diseases, cancers, and immune-deficiency disorders, and disclosures in the Company’s reports filed with the U.S. Securities and Exchange Commission (“SEC”), on its website, and in its press releases set forth its current and anticipated future activities. These activities are subject to change for a number of reasons. Pre-clinical work and other research do not necessarily indicate that Ampligen will be approved for the treatment of Ebola, and significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of Ebola. Results obtained in preclinical studies do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen will be efficacious in humans. No assurance can be given as to whether current or planned clinical trials will be successful or yield favorable data, and the trials are subject to many factors, including lack of regulatory approval(s), lack of study drug, lack of adequate funding, or a change in priorities at the institutions sponsoring other trials. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data. No assurance can be given that the findings in preliminary studies will prove true or that such studies will yield favorable results, or that future studies will not result in findings that are different from those reported in the studies referenced in the Company’s reports filed with the SEC, on the Company’s website, and in its press releases. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. The Company cannot assure that its potential foreign operations will not be adversely affected by these risks.
Actual results could differ materially from those projected in the forward-looking statements as a result of a number of risks, uncertainties, and other factors. For a detailed discussion of risk factors that could cause actual results to differ materially from those projected, please review the “Risk Factors” section in the Company’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q filed with the SEC. These filings are available at www.sec.gov and www.aimimmuno.com. The information found on the Company’s website or on other websites referenced or linked to in this press release is not incorporated by reference into this press release, and such information is referenced or linked for reference purposes only.
In addition, all of the above forward-looking statements disclosure also applies to the upcoming on-demand video presentation, which speaks only as of the date of such video presentation. Any such forward-looking statements in the video presentation should be evaluated in light of the information about forward-looking statements provided above.