Ampligen® (rintatolimod) has demonstrated promising activity as a potential maintenance therapy after systemic chemotherapy in patients with metastatic and locally advanced pancreatic cancer (LAPC)
New patient data provide further validation for advancing the development of Ampligen for the treatment of late-stage pancreatic cancer
New data were recently presented by Professor C.H.J. van Eijck, MD, PhD of Erasmus Medical Center at the 5th Dutch Multidisciplinary Gastrointestinal Oncology Congress held in Ermelo, Netherlands
OCALA, Fla., July 20, 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, today reported follow-on data from its previously published single-center named patient program. For the study, patients with locally advanced pancreatic cancer or metastatic disease were treated following FOLFIRINOX (See: Cancers 2022).
The enrollment of additional patients in the Early Access Program (EAP) was approved by the Inspectorate of Healthcare in the Netherlands and new patients have been treated at Erasmus M.C.
The Overall and Progression-Free Survival was recently presented by Professor C.H.J. van Eijck, MD, PhD, of Erasmus Medical Center (Lead Investigator) at the 5th Dutch Multidisciplinary Gastrointestinal Oncology Congress held in Ermelo, Netherlands.
Professor C.H.J. van Eijck commented, “We have learned quite a lot from the original study data we published in March and the new data provide further hope for treating late-stage patients. Multi-year survival rates for LAPC and metastatic pancreatic cancer patients are historically low, with 5-year survival typically less than 3%. These additional data, indicating major improvements to survival at 24 months and beyond, point to the potential value of Ampligen as a therapy for pancreatic cancer patients. The data bolster our confidence in the potential of Ampligen for the treatment of late-stage pancreatic cancer and represents a big step forward in Ampligen’s therapeutic development program.”
In addition, AIM has evaluated the initial data reported from 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 that data show high statistical significance, a small cohort of five (5) LAPC patients also exhibited marked improvement with the Ampligen maintenance therapy. 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.
AIM Chief Executive Officer Thomas K. Equels added, “As we progress in the immuno-oncology development of Ampligen, there has been a lot of intention and thoughtfulness related to our selection of LAPC as our primary indication target. We believe that the LAPC standard of care, FOLFIRINOX or gemcitabine + nab-paclitaxel, followed by simple observation with no additional therapy until progression, allows for a much clearer comparison to the randomized control, in contrast to a multi-faceted primary standard of care for metastatic pancreatic cancer patients. This provides an opportunity to investigate Ampligen’s effect more accurately on pancreatic cancer in the LAPC patients in the United States. Now more than ever, we are dedicated to progressing this program forward with the hope of bringing significant benefit to LAPC patients on a global scale.”
Based on the data demonstrated to date, the Company is advancing the development of Ampligen in a Phase 2 study to evaluate its potential as a therapy for locally advanced pancreatic cancer (AMP-270). AMP-270 is planned to be 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. The AMP-270 is expected to enroll approximately 90 subjects in up to 30 centers across the U.S. and Europe (60 subjects in the Ampligen group and 30 subjects in the control group). The Buffett Cancer Center at the University of Nebraska Medical Center (UNMC) and Erasmus MC in the Netherlands are expected to be the primary study sites.
To manage the AIM-sponsored Phase 2 study, on April 7, 2022, the Company engaged Amarex Clinical Research LLC, a CRO with a strong track record on advising sponsors through the product development process and providing customized solutions for clinical studies. The AMP-270 clinical trial is on track to commence in Q3 2022.
About AIM ImmunoTech Inc.
AIM ImmunoTech Inc. is an immune-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.
Ampligen is currently being used as a monotherapy to treat pancreatic cancer patients in an Early Access Program (EAP) approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center and AIM plans to initiate a Phase 2 clinical study in 2022. The Company also has multiple ongoing clinical trials to evaluate Ampligen as a combinational therapy for the treatment of a variety of solid tumor types both underway and planned at major cancer research centers. Additionally, Ampligen is approved in Argentina for the treatment of severe chronic fatigue syndrome (CFS) and is currently being evaluated in many aspects of SARS-CoV-2/COVID-19 treatments and COVID-19 Long Hauler treatment.
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. For instance, given the small number of subjects, the current findings are not statistically significant and, while the Company projects more significant results when the subject group increases and, in this regard, is planning the AMP-270 study, no assurance can be given that these projections will prove true or that the AMP-270 study will yield favorable results. 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
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