- Ampligen® (rintatolimod) has demonstrated
promising activity as a potential maintenance therapy after systemic
chemotherapy in patients with advanced pancreatic cancer
- Company engages world-renowned CRO, Amarex Clinical Research LLC to conduct upcoming Phase 2 study
- Company on track to commence Phase 2 study of Ampligen in advanced pancreatic cancer in Q3 2022
OCALA, Fla., April 12, 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 provided an update on its development
program evaluating Ampligen® for the treatment of pancreatic cancer.
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 a named patient program approved by the
Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center.
“We
continue to be encouraged by the progress and data demonstrated by
Ampligen for the treatment of pancreatic cancer. Over the past couple of
months, we have made noteworthy advancements on multiple fronts,
including FDA notice that we are authorized to proceed with our Phase 2
study. Additionally, we continue to amass an encouraging growing body of
data that supports our belief in Ampligen to offer an important
treatment option to patients living with pancreatic cancer. We are
committed to driving this program forward and working hand-in-hand with
our CRO, Amarex, to advance our Phase 2 study, which is on track to
commence in the third quarter of this year,” commented Thomas Equels,
Chief Executive Officer of AIM.
The Company
recently 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.
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. The
AMP-270 is expected to enroll approximately 90 subjects in up to 30
centers across 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.
To
manage the AIM-sponsored Phase 2 study, on April 7, 2022, the Company
engaged Amarex Clinical Research LLC, a CRO with strong track record on
advising sponsors through the product development process and providing
customized solutions for clinical studies. The AMP-270 clinical trial is
on track to commence in Q3 2022.
Additionally,
recently published data from a single-center named patient program
indicated that patients receiving Ampligen had a longer median survival
time than matched historical controls. For the study, patients with
locally advanced pancreatic cancer (LAPC) or metastatic disease were
treated with Ampligen at 2 doses per week with 400 mg per infusion. The
manuscript detailing the positive data from the program, 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 March 2022 in the peer-reviewed journal, Cancers Special
Issue: Combination and Innovative Therapies for Pancreatic Cancer.
Based on these data, the Company believes that Ampligen could prove to
be a potential effective maintenance therapy after systemic chemotherapy
in patients with advanced pancreatic cancer.
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. 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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