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
Ampligen® (rintatolimod) is being
evaluated 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
Treatment
with Ampligen following FOLFIRINOX was associated with improved
survival rates in pancreatic cancer patients compared to matched
controls of patients who did not receive Ampligen
Phase 2 study in locally advanced pancreatic cancer patients expected to commence in Q2/Q3 2022
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.
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. 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.
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)
Print Page
Email to a Friend
