AIM ImmunoTech Receives Erasmus Medical Center Ethics Board Authorization for Phase 2 Study of Ampligen® for the Treatment of Locally Advanced Pancreatic Cancer

Rhea-AI Summary

AIM ImmunoTech Inc. has received authorization from the Erasmus Medical Center Ethics Committee to open a European site for the ongoing Phase 2 study of Ampligen as a therapy for locally advanced pancreatic cancer. The approval is a significant step towards enrolling subjects in the European arm of the clinical trial. The study aims to compare the efficacy of Ampligen versus a no treatment control group following FOLFIRINOX for subjects with locally advanced pancreatic adenocarcinoma. Subject enrollment is expected in Q1 2024, with approximately 90 subjects to be enrolled in the United States and Europe.

Oncology Doctor

Pancreatic cancer is a notoriously difficult disease to treat, with locally advanced pancreatic cancer presenting a particularly challenging scenario due to limited treatment options and poor prognosis. The authorization of the European site for the Phase 2 study of Ampligen, an experimental therapeutic, represents a significant step in the development process. From an oncological perspective, the primary objective of comparing the efficacy of Ampligen with a no-treatment control group is a rigorous approach to evaluating its potential benefits. This study will provide valuable data on whether Ampligen can improve outcomes for patients following FOLFIRINOX, a current standard of care chemotherapy regimen.

Secondary objectives concerning the safety and tolerability of Ampligen are equally important, as any new treatment must demonstrate a manageable safety profile to be considered viable. The enrollment of approximately 90 subjects across the United States and Europe suggests a robust sample size for a Phase 2 trial, which could yield statistically significant data. The results of this trial could potentially offer a new avenue for treatment, addressing a significant unmet medical need in the field of oncology.

Medical Research Analyst

AIM ImmunoTech's progress into the European clinical trial space with Ampligen is a critical milestone for the company's clinical development pipeline. The endorsement by Erasmus Medical Center's Ethics Committee not only validates the scientific premise of the study but also opens doors for increased patient enrollment and data diversity. From a research analysis standpoint, the structure of the AMP-270 study as a randomized, open-label, controlled, parallel-arm trial is designed to provide clear insights into Ampligen's efficacy and safety.

Moreover, the international expansion into Europe is indicative of the company's strategic intent to globalize its clinical research efforts, which could be favorable for regulatory approval processes in the future. This move may also be seen positively by investors, as it demonstrates AIM ImmunoTech's commitment to advancing its product pipeline and could potentially accelerate the path to commercialization if the trial outcomes are positive.

Market Research Analyst

The announcement of AIM ImmunoTech's expansion of the Phase 2 clinical trial for Ampligen into Europe is a strategic development that could influence the company's market position. By initiating trials in Europe, AIM not only broadens its potential market but also diversifies its clinical data set, which is crucial for understanding Ampligen's efficacy across different populations. This diversification could mitigate the risk of regional biases in clinical outcomes, which is a key consideration for investors and stakeholders.

Should Ampligen demonstrate significant efficacy and safety, AIM ImmunoTech could capture a notable share of the pancreatic cancer treatment market, which remains a high-need area with limited effective therapies. The long-term implications for the company's stock could be substantial, depending on the trial's results. In the short-term, the news of trial expansion could generate investor optimism, potentially impacting the stock's performance. However, it is essential to maintain a balanced view, recognizing that clinical trials are inherently risky and outcomes are uncertain until data is available.

Subject enrollment is expected in Q1 2024

OCALA, Fla., Jan. 24, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that it has received authorization from the Erasmus Medical Center (“Erasmus MC”) Ethics Committee to open a European site for the ongoing Phase 2 study (“AMP-270”) of Ampligen as a therapy for locally advanced pancreatic cancer.

“Approval from the governing ethics board is an important step toward enrolling subjects in the European arm of the AMP-270 clinical trial for locally advanced pancreatic cancer,” stated Prof. Casper H.J. van Eijck, MD, PhD, Pancreato-biliary Surgeon at Erasmus MC in the Netherlands. “Erasmus MC is tracking several cancer patients that we are hopeful will be enrolled in AMP-270.”

AMP-270 is a randomized, open-label, controlled, parallel-arm clinical trial with the primary objective of comparing the efficacy of Ampligen versus a no treatment control group following FOLFIRINOX for subjects with locally advanced pancreatic adenocarcinoma. Secondary objectives include comparing safety and tolerability. AMP-270 is expected to enroll approximately 90 subjects in the United States and Europe.

For more information about AMP-270, please visit ClinicalTrials.gov and reference identifier NCT05494697.

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 is a first-in-class investigational drug called Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system.

For more information, please visit aimimmuno.com and connect with the Company on Twitter, LinkedIn, and Facebook.

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,” “continue,” “believe,” “potential,” “upcoming” and other variations thereon 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. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the U.S. Securities and Exchange Commission (the “SEC”). You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Among other things, for those statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the PSLRA. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/7a656e54-b6f2-4c09-bca2-80267f05c6c4

What is the Phase 2 study of Ampligen for?

The Phase 2 study of Ampligen is for locally advanced pancreatic cancer.

What is the primary objective of the AMP-270 clinical trial?

The primary objective is to compare the efficacy of Ampligen versus a no treatment control group following FOLFIRINOX for subjects with locally advanced pancreatic adenocarcinoma.

When is subject enrollment expected?

Subject enrollment is expected in Q1 2024.

How many subjects are expected to be enrolled in the AMP-270 trial?

Approximately 90 subjects are expected to be enrolled in the United States and Europe.