Ampligen®
(rintatolimod) has demonstrated promising activity as a potential
maintenance therapy after systemic chemotherapy in patients with locally
advanced pancreatic cancer
OCALA, Fla., Aug. 18, 2022 (GLOBE NEWSWIRE) -- 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 commencement of its Phase 2
study of Ampligen as a therapy for locally advanced pancreatic cancer
(“LAPC”) (AMP-270) following receipt of Institutional Review Board
(“IRB”) approval for the trial protocol.
AIM
Chief Executive Officer Thomas K. Equels commented, “We are pleased to
reach this important step in the development of Ampligen. Receiving IRB
approval for our Phase 2 study of Ampligen for the treatment of LAPC is
the pivotal precursor to the recruitment, enrollment and treatment of
patients with locally advanced pancreatic cancer. We look forward to
providing further updates on the development of this important therapy.”
The
Company’s Phase 2 study Investigational New Drug (“IND”) application
was previously cleared by the U.S. Food and Drug Administration (“FDA”).
An IRB is a group that operates under FDA regulations and ensures, both
in advance and by periodic review, that appropriate steps are taken to
protect the rights and welfare of humans participating as subjects in
the research.
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. AMP-270 is expected to enroll approximately 90
subjects in up to 30 centers across the United States and Europe. The
Buffett Cancer Center at the University of Nebraska Medical Center and
Erasmus MC in the Netherlands are expected to be the primary study
sites.
“We expect study sites to be open and
recruiting patients in late Q3/early Q4 of 2022, with every hope of
first dose in the first patient by the end of Q4 2022,” commented Kazem
Kazempour, Ph.D., President and CEO of Amarex Clinical Research, LLC,
AIM’s Contract Research Organization for AMP-270.
For more information about the AMP-270 please visit ClinicalTrials.gov and reference identifier NCT05494697.
The
Company recently reported new, positive data following evaluation of
the initial data reported from the single-center, named patient program
at Erasmus for both metastatic and LAPC patient populations, analyzing
the subset of patients with LAPC. While the predominance of the data
collected by Erasmus is in metastatic cancer and those data show high
statistical significance, a small cohort of five (5) LAPC patients also
exhibited marked improvement with the Ampligen maintenance therapy
following FOLFIRINOX. The overall survival from the start of FOLFIRINOX
therapy of two (2) of the patients was 34 and 43 months and one patient
was still surviving at the last reported checkup in April 2022 at 54
months See: AIM Press Release July 20, 2022.
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.
Amarex
Clinical Research, LLC, an NSF International company, is a global,
full-service Contract Research Organization (CRO), whose leadership team
has significant expertise conducting biomedical research, and whose
combined experience includes the design and conduct of several hundred
clinical research projects in many therapeutic indications. Amarex
provides comprehensive services in Project Management (Phase I-IV,
BE/BA, PK/PD), Regulatory Affairs (FDA Applications and meetings,
Applications to International Health Authorities, GxP Compliance
Audits), Clinical Operations, Adaptive Study Designs, Statistical
Analysis, Data Management, Medical Monitoring, Safety and
Pharmacovigilance, and General Consulting. Amarex can take your product
through the entire approval process, from creating the regulatory
approval strategy, to conducting trials, to writing the marketing
approval application. Join our growing list of clients with approved
products. Amarex provides high quality and cost-efficient services. For
more information visit www.amarexus.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. The Phase 2 Study discussed above is subject
to a number of unknowns including, but not limited to, that while the
preliminary data in the small number of subjects shows significance, no
assurance can be given that the findings in the small study will prove
true or that the study will yield favorable results, and that
significant additional testing and trials will be required to determine
whether Ampligen will be an effective treatment for locally advanced
pancreatic cancer. 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.
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)
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