AIM ImmunoTech Reports
Positive Pilot Study Data from Expanded Access Program Evaluating
Ampligen® for the Treatment of Long COVID
Growing
body of data supports Investigational New Drug (“IND”) application with
the U.S. Food and Drug Administration (“FDA”) for a Phase 2 study of
Ampligen for the treatment of Post-COVID conditions
OCALA, Fla., July 28, 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 reported positive preliminary pilot
study data from its ongoing Expanded Access Program (“EAP or “AMP-511”)
evaluating its investigational drug, Ampligen, as a therapeutic for
“long COVID”. The preliminary data from this uncontrolled clinical trial
found that patients reported statistically significant improvements in
chronic fatigue after treatment with Ampligen. Based on these early
results, AIM is working to move forward with a Phase 2 controlled trial.
Ampligen
is AIM’s RNA product candidate being developed for globally important
cancers, viral diseases and disorders of the immune system. Ampligen
modulates the immune system and has demonstrated antiviral activity.
“Post-COVID
conditions are debilitating, can be brutally agonizing and affect
millions of people who are suffering without any viable treatment
options. The positive preliminary data demonstrated in this pilot study
bolsters our confidence in the potential of Ampligen as we continue to
drive its development as a potential therapeutic for the treatment of
long COVID. With the positive preliminary results demonstrated to date
we remain, now more than ever, steadfast in our mission to bring an
effective therapeutic option to those in need,” stated Thomas K. Equels,
CEO of AIM ImmunoTech.
AMP-511 is an ongoing,
prospective, open-label, multi-center Phase 3 study to treat myalgic
encephalomyelitis/chronic fatigue syndrome (ME/CFS) patients with
Ampligen. The study was amended in October 2020 to include patients
previously diagnosed with SARS-CoV-2 following clearance of the virus,
but who then demonstrate chronic fatigue-like symptoms — referred to as
Post-COVID Conditions. There have been four Post-COVID subjects treated
in this amendment “pilot” program. The EAP is being conducted by
investigators Charles Lapp, MD, at Hunter-Hopkins Center in Charlotte,
N.C., and Daniel Peterson, MD, at Sierra Internal Medicine in Incline
Village, Nev.
To be included under the
amendment, subjects must meet the 1988 or 1994 CDC Case Definition for
CFS. Their fatigue must have persisted or recurred during 3 or more
consecutive months of illness and must not have preceded the onset of
the COVID-19 symptoms. During the study, subjects are evaluated at
baseline (Week 0) using a Post-COVID-19 Questionnaire. They then begin
treatment with Ampligen and the COVID induced fatigue conditions are
evaluated over time.
Patients receive open label intravenous (IV) Ampligen twice weekly, with the dose escalating up to 400 mg if well-tolerated.
The
first four enrolled Post-COVID patients were treated in the study.
Evaluation of safety is a secondary objective in this study. The initial
findings for these four enrolled patients are as follows:
AMP-511 Preliminary Data: Post-COVID Condition of Fatigue Over Time
Patient 1
Patient 2
Patient 3
Patient 4
BSL
Wk 6
Wk 12
BSL
Wk 6
Wk 12
BSL
Wk 6
Wk 12
BSL
Wk 6
Wk 12
Inability to exercise or be active
10.0
10.0
7.0
8.0
5.0
4.0
10.0
8.0
7.0
9.0
7.0
8.0
Fatigue
9.5
8.0
6.0
6.0
3.0
3.0
9.0
8.0
7.0
8.0
7.0
7.0
Post exertional malaise (tiredness the day after exercise)
7.5
ND
2.0
6.0
ND
1.0
8.0
ND
5.0
8.0
ND
9.0
Wilcoxon
matched-pairs signed rank test measuring changes in total improvement
(combining exercise ability, fatigue, and post-exertional malaise) at
week 12 compared to baseline: p=0.002
BSL = baseline; Baseline is mean of 2 baseline values
ND=Not done; Post exertional malaise was not collected at week 6
Severity Scores: 1-3= Mild, 4-6= Moderate, 7-8= Severe, 9-10= Very Severe
The
reduction in fatigue observed in the first four patients provide
preliminary evidence of Ampligen’s effect in the Post-COVID Condition of
fatigue. As shown from these data, by week 12, compared to baseline,
there was what the investigators considered a clinically significant
decrease in fatigue-related measures.
Dr. Lapp
commented, “While still early, we are very encouraged by this promising
data and the significant improvement in fatigue and the ability to be
active, especially in the category of post-exertional malaise. We remain
committed to advancing development of Ampligen as a therapeutic for the
treatment of Long COVID — or Post-Acute Sequelae of Covid (PASC) — and
look forward to further evaluating its potential.”
Based
in part on these early positive data, AIM is continuing to work toward
filing an IND application with the FDA for a Phase 2 study of Ampligen
for the treatment of Post-COVID conditions. The planned IND is for 12
weeks of therapy.
Dr. Peterson commented, “As we
are aware of the previous successes of Ampligen Poly I:Poly C12U in the
treatment of a select group of subjects with Chronic Fatigue Syndrome, I
began consideration of subjects with well-documented long COVID
syndrome for the use of Ampligen per the approved protocol. The first
subject fulfilled the current criteria for long COVID disease and had no
contraindications. The subject was begun on Ampligen under the protocol
and had a gradual and consistent improvement observed by myself, the
subject's family, as well as the nursing staff. The subject has had a
dramatic improvement in energy and cognitive function with near complete
clearing of her brain fog. The subject will continue according to the
protocol to maximal clinical improvement. Due to the subject’s rather
dramatic improvement in a relatively short period of time, I have
proposed an additional five subjects for entry into the Ampligen
protocol for long COVID.”
About AIM ImmunoTech Inc.
AIM
ImmunoTech Inc. is an immune-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. Ampligen is currently being
used as a monotherapy to treat pancreatic cancer patients in an Early
Access Program approved by the Inspectorate of Healthcare in the
Netherlands at Erasmus Medical Center. The Company also has multiple
ongoing clinical trials to evaluate Ampligen as a combinational therapy
for the treatment of a variety of solid tumor types both underway and
planned at major cancer research centers. Additionally, Ampligen is
currently being used to treat chronic fatigue patients and patients with
Post-COVID condition of fatigue and AIM plans to initiate a Phase 2
clinical study in 2022. Ampligen is approved in Argentina for the
treatment of severe chronic fatigue syndrome (CFS) and is currently
being evaluated in many aspects of SARS-CoV-2/COVID-19 treatments and
COVID-19 Long Hauler treatment.
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. For instance, while the preliminary data in
the small number of subjects shows significance, the Company is planning
a controlled phase 2 trial and no assurance can be given that the
findings in the small study will prove true or that the study will yield
favorable results. Significant additional testing and trials will be
required to determine whether Ampligen will be an effective treatment
for Long COVID. Additionally, there is no guarantee as to when or
whether an IND application will be submitted to the U.S. Food and Drug
Administration, nor, if an application is submitted, whether it will be
accepted. 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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