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

Key Takeaway: AIM ImmunoTech has received ethics board authorization from Erasmus Medical Center to open a European site for its Phase 2 study of Ampligen in treating locally advanced pancreatic cancer. The AMP-270 trial will compare Ampligen's efficacy against a no-treatment control group. The study aims to enroll around 90 subjects across the U.S. and Europe.
Price reaction · baseline $0.4296 (2024-01-23 close) · hit pre-market · clean, no other AIM news in the window
day 0 close · peak
-6.9%
day 1
-3.5%
day 3
-2.3%

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POSITIVE FACTORS

  • Authorization received from Erasmus MC Ethics Committee.
  • Important step toward enrolling subjects in clinical trial.
  • Study aims to compare efficacy of Ampligen in treating pancreatic cancer.
  • Expected enrollment of approximately 90 subjects in the trial.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+20%
120-day peak, hindsight
Typical move
16.5%
average across 4 past catalysts
Cash runway
~6 mo
High dilution risk
Lead asset
poly I-poly C12U
Phase 2 · HIV Seropositivity

Full Press Release Details

OCALA, Fla., Jan. 24, 2024 — 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.

Frequently Asked Questions

What is the AMP-270 clinical trial?

AMP-270 is a Phase 2 clinical trial comparing Ampligen's efficacy against a no-treatment control group for pancreatic cancer.

How many subjects will be enrolled in the study?

The study aims to enroll approximately 90 subjects across the United States and Europe.

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

The primary objective is to compare the efficacy of Ampligen following FOLFIRINOX treatment.

Who approved the Phase 2 study for Ampligen?

The Erasmus Medical Center Ethics Committee authorized the Phase 2 study.

Last updated: Jan 24, 2024