On August 18, 2022 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 the commencement of its Phase 2 study of Ampligen as a therapy for locally advanced pancreatic cancer ("LAPC") (AMP-270) following receipt of Institutional Review Board ("IRB") approval for the trial protocol (Press release, AIM ImmunoTech, AUG 18, 2022, View Source [SID1234618476]).

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AIM Chief Executive Officer Thomas K. Equels commented, "We are pleased to reach this important step in the development of Ampligen. Receiving IRB approval for our Phase 2 study of Ampligen for the treatment of LAPC is the pivotal precursor to the recruitment, enrollment and treatment of patients with locally advanced pancreatic cancer. We look forward to providing further updates on the development of this important therapy."

The Company’s Phase 2 study Investigational New Drug ("IND") application was previously cleared by the U.S. Food and Drug Administration ("FDA"). An IRB is a group that operates under FDA regulations and ensures, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research.

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. AMP-270 is expected to enroll approximately 90 subjects in up to 30 centers across the United States and Europe. The Buffett Cancer Center at the University of Nebraska Medical Center and Erasmus MC in the Netherlands are expected to be the primary study sites.

"We expect study sites to be open and recruiting patients in late Q3/early Q4 of 2022, with every hope of first dose in the first patient by the end of Q4 2022," commented Kazem Kazempour, Ph.D., President and CEO of Amarex Clinical Research, LLC, AIM’s Contract Research Organization for AMP-270.

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

The Company recently reported new, positive data following evaluation of the initial data reported from the single-center, named patient program at Erasmus for both metastatic and LAPC patient populations, analyzing the subset of patients with LAPC. While the predominance of the data collected by Erasmus is in metastatic cancer and those data show high statistical significance, a small cohort of five (5) LAPC patients also exhibited marked improvement with the Ampligen maintenance therapy following FOLFIRINOX. The overall survival from the start of FOLFIRINOX therapy of two (2) of the patients was 34 and 43 months and one patient was still surviving at the last reported checkup in April 2022 at 54 months See: AIM Press Release July 20, 2022.

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.