AIM ImmunoTech Receives IND Clearance from the U.S. FDA to Advance its Phase 2 Study of Ampligen® for the Treatment of Locally Advanced Pancreatic Cancer
March 16 2022 - 6:05AM
AIM ImmunoTech Receives IND Clearance from the U.S. FDA to Advance
its Phase 2 Study of Ampligen® for the Treatment of Locally
Advanced 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 it has
received notification from the U.S. Food and Drug Administration
(“FDA”) that the FDA’s Clinical Hold on AIM’s investigational new
drug (“IND”) application for a Phase 2 study of Ampligen as a
therapy for locally advanced pancreatic cancer (AMP-270) has been
lifted and the Company may proceed with the study.
“Based on the data we’ve seen to date, we
believe Ampligen has the potential to offer an important treatment
option to patients living with pancreatic cancer. This is a
significant milestone for the Company and further positive Phase 2
confirmation of these results would demonstrate the potential of
Ampligen as an effective therapy option. We are incredibly pleased
and grateful to the FDA for its authorization, which enables us to
proceed with further clinical evaluation. Our team is focused on
commencing our Phase 2 study which we believe brings us another
step closer to providing a potentially effective therapy after
systemic chemotherapy in patients with advanced pancreatic cancer,”
commented Thomas Equels, Chief Executive Officer of AIM.
The AMP-270 clinical trial 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. We plan to enroll
approximately 90 subjects across up to 30 centers in the U.S. and
Europe. 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. Amarex Clinical Research
will manage the AIM-sponsored Phase 2 study.
Prof. Casper H.J. van Eijck, MD, PhD,
Pancreato-biliary Surgeon at Erasmus MC, states, “The longer median
Progression Free Survival and overall survival rates of our
patients treated with Ampligen that we have seen already are very
encouraging and warrant further evaluation. With this devastating
disease where there remains a need for more effective therapies, we
are excited to advance the development of this important asset that
has shown promise in addressing that need. I believe Ampligen has
the potential to be a meaningful extension to the standard of care
for advanced pancreatic cancer and I look forward to seeing the
results of this next trial.”
Prof. Michael A. “Tony” Hollingsworth, PhD, of
the Buffett Cancer Center at UNMC, states, “We are excited to
undertake this clinical trial and associated correlative studies to
better understand the mechanism by which Ampligen may extend
survival of pancreatic cancer patients. The development of new
therapeutic options is of utmost importance to the pancreatic
cancer community, as we have so few options for patients.”
Prof. Kelsey Klute, MD, of the Buffett Cancer
Center at UNMC, stated, “Ampligen has shown promising activity in
treating pancreatic cancer in the Erasmus Program and in
preclinical models. This is an important step toward formally
testing its activity in patients affected by this devastating
disease.”
Ampligen is AIM’s dsRNA product candidate being
developed for globally important cancers, viral diseases and
disorders of the immune system. Ampligen has demonstrated in the
clinic the potential for standalone efficacy in a number of solid
tumors. Additionally, Ampligen has shown success in increasing
survival rates and efficacy in the treatment of animal tumors when
used in combination with checkpoint blockade therapies. Ampligen is
currently being evaluated as a combinational therapy for the
treatment of a variety of solid tumor types in multiple clinical
trials — both underway and planned — at major cancer research
centers around the country. Ampligen is also 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.
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 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. 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.
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/b763067c-ce12-4f3f-8fdd-e346162c0545
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