AIM ImmunoTech Announces Phase 2 Study of Ampligen® for the Treatment of Pancreatic Cancer is Open and Recruiting Patients
February 28 2023 - 7:45AM
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 that the
AMP-270 Phase 2 study of Ampligen as a therapy for locally advanced
pancreatic cancer (“LAPC”) has opened its first clinical site and
has begun recruiting patients.
The AMP-270 clinical trial is 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.
Thomas K. Equels, M.S., J.D., Chief Executive
Officer of AIM ImmunoTech, commented, “We continue to believe that
Ampligen and the AMP-270 study have the potential to establish a
much-needed new standard of care for LAPC where there remains a
significant unmet need. Our team continues to execute on advancing
this important study forward and we are pleased that the first of
our sites is open for recruitment. We are working closely with
preeminent cancer institutions across the United States and Europe
to build momentum toward the commencement of patient enrollment and
dosing and look forward to achieving those milestones as soon as
possible.”
AMP-270 is expected to enroll approximately 90
subjects in up to 30 centers across the United States and Europe.
The site at Gabrail Cancer & Research Center in Canton, Ohio,
has opened, with additional clinical sites at other premier cancer
centers across the U.S. and Europe expected to open and enroll
patients in the near future.
For more information about the AMP-270 please
visit ClinicalTrials.gov and reference identifier NCT05494697.
About Ampligen
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 being
used to treat pancreatic cancer patients in an Early Access Program
approved by the Inspectorate of Healthcare in the Netherlands at
Erasmus Medical Center. Additionally, Ampligen is also approved in
Argentina for the treatment of severe chronic fatigue syndrome and
is currently being evaluated in SARS-CoV-2/COVID-19, myalgic
encephalomyelitis/chronic fatigue syndrome (ME/CFS) and Post COVID
Conditions.
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 Company’s lead product, Ampligen® (rintatolimod) is an
immuno-modulator with broad spectrum activity being developed for
globally important cancers, viral diseases and disorders of the
immune system.
For more information, please visit aimimmuno.com and connect
with the Company on Twitter, LinkedIn, and Facebook.
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. The clinical study discussed above is subject to a
number of unknowns including, but not limited to, whether an
appropriate number of participants can be enrolled, and that
significant additional testing and trials will be required to
determine whether Ampligen will be an effective treatment for LAPC
or any other cancers, immune disorders or viral diseases. Among
other things, for those statements, the Company claims the
protection of safe harbor for forward-looking statements contained
in the PSLRA. 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
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