AIM ImmunoTech Provides Clinical Updates on Planned Phase 2 Study of Ampligen in Patients with Locally Advanced or Metastatic Late-Stage Pancreatic Cancer
05 October 2021 - 12:20AM
AIM ImmunoTech Provides Clinical Updates on Planned Phase 2 Study
of Ampligen in Patients with Locally Advanced or Metastatic
Late-Stage Pancreatic Cancer
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.
Amarex Clinical Research will manage the AIM-sponsored study.
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, although additional sites are expected to
participate.
AIM’s Pancreatic Cancer Research
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.
Contacts:
Crescendo Communications, LLCPhone:
212-671-1021Email: aim@crescendo-ir.com
AIM ImmunoTech IncPhone:
800-778-4042Email: IR@aimimmuno.com
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