AIM ImmunoTech Announces Phase 2 Study of Ampligen® for the Treatment of Pancreatic Cancer is Open and Recruiting Patients

Rhea-AI Summary

AIM ImmunoTech Inc. (NYSE American: AIM) has announced the opening of its first clinical site for the AMP-270 Phase 2 study, evaluating Ampligen for locally advanced pancreatic cancer (LAPC). This randomized study compares the efficacy of Ampligen to a no-treatment control after FOLFIRINOX therapy. The trial aims to enroll approximately 90 subjects across 30 centers in the U.S. and Europe. CEO Thomas K. Equels emphasized the potential of Ampligen to set a new standard of care for LAPC, highlighting ongoing recruitment efforts at prominent cancer institutions.

Positive

• Opening of the AMP-270 Phase 2 study's first clinical site for Ampligen.
• Potential to establish a new standard of care for locally advanced pancreatic cancer.
• Ongoing recruitment at premier cancer centers across the U.S. and Europe.

Negative

• Enrollment challenges for the clinical study could hinder progress.
• Uncertainties regarding the effectiveness of Ampligen for LAPC and other conditions due to required additional testing.

Ongoing efforts to open additional clinical sites for recruitment at premier cancer centers across the U.S. and Europe are in progress to facilitate patient enrollment and dosing

OCALA, Fla., Feb. 28, 2023 (GLOBE NEWSWIRE) -- 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 that the AMP-270 Phase 2 study of Ampligen as a therapy for locally advanced pancreatic cancer (“LAPC”) has opened its first clinical site and has begun recruiting patients.

The AMP-270 clinical trial is a randomized, open-label, controlled, parallel-arm study 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.

Thomas K. Equels, M.S., J.D., Chief Executive Officer of AIM ImmunoTech, commented, “We continue to believe that Ampligen and the AMP-270 study have the potential to establish a much-needed new standard of care for LAPC where there remains a significant unmet need. Our team continues to execute on advancing this important study forward and we are pleased that the first of our sites is open for recruitment. We are working closely with preeminent cancer institutions across the United States and Europe to build momentum toward the commencement of patient enrollment and dosing and look forward to achieving those milestones as soon as possible.”

AMP-270 is expected to enroll approximately 90 subjects in up to 30 centers across the United States and Europe. The site at Gabrail Cancer & Research Center in Canton, Ohio, has opened, with additional clinical sites at other premier cancer centers across the U.S. and Europe expected to open and enroll patients in the near future.

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

About Ampligen

Ampligen is AIM’s dsRNA product candidate being developed for globally important cancers, viral diseases and disorders of the immune system. Ampligen has demonstrated in the clinic the potential for standalone efficacy in a number of solid tumors. Additionally, Ampligen has shown success in increasing survival rates and efficacy in the treatment of animal tumors when used in combination with checkpoint blockade therapies.

Ampligen is currently being evaluated as a combinational therapy for the treatment of a variety of solid tumor types in multiple clinical trials – both underway and planned – at major cancer research centers around the country. Ampligen is being used to treat pancreatic cancer patients in an Early Access Program approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center. Additionally, Ampligen is also approved in Argentina for the treatment of severe chronic fatigue syndrome and is currently being evaluated in SARS-CoV-2/COVID-19, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and Post COVID Conditions.

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.

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” 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 clinical study discussed above is subject to a number of unknowns including, but not limited to, whether an appropriate number of participants can be enrolled, and that significant additional testing and trials will be required to determine whether Ampligen will be an effective treatment for LAPC or any other cancers, immune disorders or viral diseases. Among other things, for those statements, the Company claims the protection of 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.

Investor Relations Contact
JTC Team, LLC
Jenene Thomas
833-475-8247
AIM@jtcir.com  

 

FAQ

What is the AMP-270 Phase 2 study about?

The AMP-270 Phase 2 study evaluates the efficacy of Ampligen as a therapy for locally advanced pancreatic cancer in comparison to a no-treatment control after FOLFIRINOX.

How many patients will the AMP-270 study enroll?

The study aims to enroll approximately 90 subjects across 30 clinical centers in the U.S. and Europe.

What is the significance of Ampligen in this study?

Ampligen is being tested for its potential to set a new standard of care for locally advanced pancreatic cancer, addressing a significant unmet medical need.

When did the AMP-270 clinical trial begin recruitment?

Recruitment for the AMP-270 clinical trial began with the opening of the first clinical site on February 28, 2023.

What are the next steps for AIM ImmunoTech after opening the trial site?

AIM ImmunoTech plans to open additional clinical sites and facilitate patient enrollment and dosing as part of the AMP-270 study.