On February 28, 2023 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 – reported 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 (Press release, AIM ImmunoTech, FEB 28, 2023, View Source [SID1234627800]).
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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.