AIM ImmunoTech’s Ampligen Safety Data Presented at Eighth European Scientific Working Group on Influenza

Rhea-AI Summary

AIM ImmunoTech announced that safety data for its drug Ampligen was presented at the Eighth European Scientific Working Group on Influenza conference held virtually from December 4-7, 2021. The Centre for Human Drug Research shared interim results from a Phase 1 clinical study, which involved 40 healthy subjects. The study showed no severe adverse events at various dosages of Ampligen. AIM expects to receive the complete study report in January 2022. The company focuses on developing therapeutics for cancers, immune disorders, and viral diseases, including COVID-19.

Positive

• None.

Negative

• Awaiting final study report from CHDR creates uncertainty about long-term efficacy.
• Ampligen requires significant additional testing to confirm effectiveness against COVID-19.
• The potential for clinical trial delays due to the ongoing COVID-19 emergency.

OCALA, Fla., Dec. 09, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) today announced that safety data on its drug Ampligen was recently presented at the Eighth European Scientific Working Group on Influenza (ESWI) virtual conference in Salzburg, Austria, on December 4-7, 2021. The conference also included research on COVID-19 and respiratory syncytial virus.

The Centre for Human Drug Research (CHDR) presented previously announced data from a Phase 1 clinical study to assess the safety, tolerability and biological activity of Ampligen as a potential intranasal therapy. A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with the Ampligen given at four escalating dosages across four cohorts, to a maximum level of 1,250 micrograms. The study reported no Severe Adverse Events at any dosage level.

The complete presentation is available on the AIM ImmunoTech website in the events/presentations section.

AIM expects to receive the full study report from CHDR in January 2022.

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 disease caused by the SARS-CoV-2 virus. For more information, please visit www.aimimmuno.com.

Cautionary Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Words such as “may,” “will,” “expect,” “plan,” “anticipate” and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. The CHDR presentation at the ESWI Conference concerns interim results, and the Company awaits a final study report. While the results of the CHDR study indicate the safety and tolerability of repeated intranasal administration of Ampligen, significant additional testing will be required to confirm whether Ampligen is an effective prophylactic or early treatment against COVID-19 or any other respiratory viral infections. No assurances can be given as to whether any studies will be successful or yield favorable data. Additionally, studies and trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. There is also the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

Contacts:

Crescendo Communications, LLC
Phone: 212-671-1021
Email: aim@crescendo-ir.com

AIM ImmunoTech Inc
Phone: 800-778-4042
Email: IR@aimimmuno.com

FAQ

What safety data was presented for Ampligen at the ESWI conference?

Safety data for Ampligen showed no severe adverse events in a Phase 1 study involving 40 subjects.

When does AIM expect to receive the full study report for Ampligen?

AIM expects to receive the full study report from the Centre for Human Drug Research in January 2022.

What are the implications of the safety data for AIM ImmunoTech shareholders?

The interim safety data is positive, but further testing is needed, posing risks for shareholders.

What challenges does AIM face for the Ampligen COVID-19 treatment?

AIM faces challenges such as the need for substantial additional testing and potential delays in clinical trials.