AIM ImmunoTech Announces Publication of Positive Data from Late-Stage Pancreatic Cancer Early Access Program (EAP) in the Cancers Special Issue: Combination and Innovative Therapies for Pancreatic Cancer
09 March 2022 - 5:59AM
AIM ImmunoTech Announces Publication of Positive Data from
Late-Stage Pancreatic Cancer Early Access Program (EAP) in the
Cancers Special Issue: Combination and Innovative Therapies for
Pancreatic Cancer
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 announced the
publication of positive data from a single-center named patient
program treating advanced and metastatic pancreatic cancer
patients. The manuscript titled, “Rintatolimod (Ampligen®) enhances
numbers of peripheral B cells and is associated with longer
survival in patients with locally advanced and metastasized
pancreatic cancer pre-treated with FOLFIRINOX: a single-center
named patient program1,” was published in the peer-reviewed
journal, Cancers Special Issue: Combination and Innovative
Therapies for Pancreatic Cancer.
In the single-center named patient program,
patients with locally advanced pancreatic cancer (LAPC) or
metastatic disease were treated with Ampligen for 6 weeks, at 2
doses per week with 400 mg per infusion. The study found that
Ampligen improved the median survival of these patients.
“We are very encouraged by these data, which we
believe reaffirm the potential of Ampligen to offer an important
treatment option to patients living with pancreatic cancer. These
data now in hand play a key role in the overall advancement of our
pancreatic cancer program and provide valuable insight as we
continue to execute the path forward. We continue to be encouraged
by the favorable results demonstrated with Ampligen and are
committed to securing the next phase of development of this
important program,” commented Thomas Equels, Chief Executive
Officer of AIM.
The study’s primary endpoints were the Systemic
Immune-Inflammation Index (SIII), the Neutrophils to Lymphocyte
Ratio (NLR), and absolute counts of 18 different populations of
circulating immune cells as measured by flow cytometry. Secondary
endpoints were progression-free survival (PFS) and overall survival
(OS). The median overall survival in the Ampligen group was 19
months, compared to a historical control group and subgroup (7.5
and 12.5, respectively) that did not receive Ampligen.
“This is the first study investigating the
immunomodulatory effect of the TLR-3 agonist Ampligen in patients
with locally advanced or metastatic pancreatic cancer following
FOLFIRINOX therapy and these results are compelling. We remain
encouraged by the data demonstrating patients who were treated with
Ampligen had a longer median PFS and overall survival compared to
matched controls of patients who did not receive Ampligen. We look
forward to further evaluation of Ampligen as a treatment for
pancreatic cancer in our upcoming Phase 2 study,” stated David
Strayer, MD, Chief Medical Officer, Chief Scientific Officer of the
Company and Board Certified in Medical Oncology.
Prof. Casper H.J. van Eijck, MD, PhD,
Pancreato-biliary Surgeon at Erasmus MC and co-author of the
published manuscript added, “There remains a critical need for more
effective therapies to treat this devastating disease. Based on
these positive data, I believe Ampligen has the potential to be a
meaningful extension to the standard of care for advanced
pancreatic cancer and may offer much needed hope for patients and
families. Of particular note, we were pleased to see the improved
overall survival rates of our patients treated with Ampligen. These
initial data suggest Ampligen has the potential to be an important
treatment for pancreatic cancer patients, and I look forward to
being a part of the planned Phase 2 study.”From January 2017 to
February 2019, a total of 42 patients with LAPC or metastasized
disease were treated with Ampligen. Twenty-seven of the patients
had been treated with FOLFIRINOX prior to Ampligen. Of the 27
patients, 25 patients completed the first cycle of Ampligen. Based
on OS after Ampligen treatment, the 27 patients were divided into
11 long-term survivors and 16 short-term survivors.
Ampligen was administered in cycles of six
weeks. Patients received treatment for a maximum of three cycles of
six weeks or until progression. A treatment cycle consisted of
twice per week intravenous administration of 200 milligrams in the
first two weeks and 400 milligrams in the last 4 weeks. Laboratory
assessments and peripheral blood sample collections for immunology
flow cytometry analysis were obtained at baseline and 5 days after
the last infusion of the first treatment cycle. Progression of
disease was assessed by CT imaging scans according to RECIST
criteria 1.1 and serum carbohydrate antigen 19-9 examinations every
3 months during follow-up, if clinically indicated or when
recurrence was suspected.Key Results
Highlights
- While at 6 weeks, the Systemic
Immune-Inflammation Index (SIII) and the Neutrophils to Lymphocyte
Ratio (NLR) values from the long-term and short-term patients
combined showed no significant difference compared to baseline, the
values were found to be significantly lower in 11 long-term
survivors versus 16 short-term survivors.
- The numbers of B-cells were
significantly increased in long-term survivors. T-cells and myeloid
cells were not significantly increased after treatment with
Ampligen.
- The median PFS was significantly
longer (13 months) with rintatolimod compared to both matched
controls and the subset of matched controls (5 and 8.6 months,
respectively); hazard ratio was 0.51; 95% CI 0.28-0.90,
p=0.007.
- The median overall survival was
significantly longer (19 months) with Ampligen compared to both
matched controls and the subset of matched controls (7.5 and 12.5,
respectively); hazard ratio was 0.52; 95% CI 0.28 – 0.90,
p=0.016.
- At the time of analysis in November
2021, a total of three patients with the metastasized disease were
still alive.
Based on these data, the Company believes that
Ampligen could be a potential effective maintenance therapy after
systemic chemotherapy in patients with advanced pancreatic
cancer.
The Company plans to conduct a Phase 2 study of
Ampligen as a therapy for locally advanced pancreatic cancer. The
planned AMP-270 clinical trial of approximately 90 subjects will 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 carcinoma. Secondary objectives include
comparing safety and tolerability.
Amarex Clinical Research will manage the
AIM-sponsored Phase 2 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 anticipated.
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. For
more information, please visit www.aimimmuno.com.
Cautionary StatementThis 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.
While the Company believes that the results of the above discussed
single-center named patient program were positive, significant
additional testing will be required. Among other things, the study
included only a small number of selected patients and lacked
randomization. While the Company plans to sponsor a Phase 2 study,
no assurance can be given that the study or any future studies will
be timely conduced, successful or yield favorable data.
Additionally, 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.
There is also the potential for delays in clinical trial enrollment
and reporting because of the COVID-19 medical emergency. We
previously noted that the FDA placed a clinical hold on our
Pancreatic Cancer IND. However, we have been corresponding with the
FDA and we anticipate, but cannot assure, that the hold will be
lifted. 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 ContactJTC
Team, LLCJenene Thomas 833-475-8247AIM@jtcir.com
__________________________________1 Cancers
2022, 14(6), 1377; https://doi.org/10.3390/cancers14061377
(registering DOI)
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