AIM ImmunoTech Provides
Clinical Updates on Planned Phase 2 Study of Ampligen in Patients with
Locally Advanced or Metastatic Late-Stage Pancreatic Cancer
Expects to submit IND and apply for Fast Track Status with the FDA by October 18, 2021
Selects the Buffett Cancer Center and Erasmus MC as primary study sites
OCALA,
Fla., Oct. 04, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE
American: AIM) today announced that it has finalized the protocol for a
planned Phase 2 study of the company’s drug Ampligen as a therapy for
locally advanced or metastatic late-stage pancreatic cancer. The company
expects to submit both an Investigational New Drug application (IND)
and an application for Fast Track status with the U.S. Food and Drug
Administration (FDA) no later than October 18, 2021.
The
new proposed study is based on statistically significant clinical data
in an early-access program where 27 subjects were treated at Erasmus MC
in The Netherlands. The overall survival of the Ampligen-treated cohort
was 19.2 months from the start of FOLFIRINOX, compared to 12.5 months in
the historical control group. This increase of 6.7 months in the
Ampligen-treated group was clinically and statistically significant.
Additionally, several subjects are still alive more than three years
later. These detailed data were filed with and supported the recent
approval of orphan drug status for Ampligen by both the FDA and the
European Medicines Agency. These detailed data will also be a component
of the upcoming Phase 2 IND submission and a justification for the Fast
Track application.
Prof. C.H.J. van Eijck, MD, PhD, and his team at Erasmus MC
intend to publish a detailed clinical report on their results in a
peer-reviewed journal no later than January 2022. AIM will publicly
release the detailed data and analysis at that time.
Overview of the Planned AMP-270 Study
The
planned AMP-270 clinical trial will be a Phase 2, randomized,
open-label, controlled, parallel-arm study with the primary objective of
comparing the efficacy of Ampligen when added to SOC (standard of care)
versus SOC alone for subjects with advanced pancreatic carcinoma
recently treated with FOLFIRINOX chemotherapy regimen. Secondary
objectives include comparing safety and tolerability. There will be two
parallel arms and approximately 250 eligible subjects will be randomized
1:1 to receive either 1) Ampligen alone or Ampligen combined with SOC,
or 2) SOC alone.
The parallel control arm will receive SOC
without Ampligen. This will consist of monitoring for disease
progression along with active anticancer therapy as determined by the
patients’ physicians.
Patients in the Ampligen-plus-SOC arm will
be administered twice weekly Ampligen intravenous (IV) infusions.
Subjects will be monitored for disease progression and may also receive
anticancer SOC therapy (depending on their treating physicians).
Amarex
CEO Kazem Kazempour, PhD, states: “The Phase 2 study design includes an
interim data analysis intended to allow for the transition from a Phase
2 to a Phase 3 study pending the FDA’s review and approval. The interim
data may also allow for a “Breakthrough” drug designation from the FDA,
which provides significant advantages to the clinical development
program.”
Pancreatic Cancer Subject-Matter Experts Discuss the New Study
Prof.
Kelsey Klute, MD, of the Buffett Cancer Center at UNMC, and the study’s
principal investigator in the United States, states: “Most people
diagnosed with pancreatic cancer don’t survive more than a year after
their diagnosis. There is a critical need for more effective therapies
to treat this lethal disease. Based on the Erasmus data and our
preclinical data, we’re optimistic about the activity of Ampligen in
treating pancreatic cancer. We’ve designed this clinical trial to test
whether Ampligen improves survival compared to the current standard of
care. But I think it’s equally important that this study will also help
us understand the effect of Ampligen at the cellular level of the tumor
and the immune system – to learn why and how it works in certain
patients and why it might fail in others – and set the stage to refine
the use of Ampligen in the future.”
Prof. Michael A. “Tony”
Hollingsworth, PhD, also of UNMC, a world-renowned pancreatic cancer
researcher who is designing exploratory experimental endpoints to
supplement the survival-based primary endpoint, states: “We have
designed correlative studies to test the hypothesis that administration
of Ampligen in the maintenance setting will improve survival by
enhancing tumor-specific immunity and also systemic immunity to
opportunistic pathogens that contribute to the patients demise during
end stage disease.”
Prof. C.H.J. van Eijck, MD, PhD, states:
“The overall survival of the experimental group was compared to a well
matched historical control cohort matched for age, gender, stage of
disease, and number of cycles of FOLFIRINOX chemotherapy. Median
survival was significantly higher in the Ampligen arm as compared to the
historical controls. Based on these data, I see the potential for
Ampligen as a meaningful extension of the standard of care for advanced
pancreatic cancer, which we are planning to investigate further in the
upcoming randomized control trial.”
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 disease caused by
the SARS-CoV-2 virus.
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. Among other things, for those statements, the
Company claims the protection of safe harbor for forward-looking
statements contained in the PSLRA. No assurances can be given as to
whether the FDA will promptly authorize the Company’s IND or require
significant changes or grant Fast Track status. If the IND is
authorized, no assurance can be given that any studies will be
successful or yield favorable data. Studies and trials are subject to
many factors including lack of regulatory approval(s), lack of study
drug, or a change in priorities at the institutions sponsoring other
trials. Significant additional testing and trials will be required to
determine whether Ampligen will be an effective therapy for locally
advanced or metastatic late-stage pancreatic cancer or otherwise, and no
assurance can be given that this will be the case. There is the
potential for delays in clinical trial enrollment and reporting because
of the COVID-19 medical emergency. We do not undertake to update any of
these forward-looking statements to reflect events or circumstances that
occur after the date hereof.
BioFlorida is the voice of Florida's life sciences industry, representing 8,600 establishments and research organizations in the BioPharma, MedTech, Digital Health and Health Systems that collectively employ nearly 107,000 Floridians. Source: TEConomy/BIO (released 2022)
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