AIM ImmunoTech Provides Update on Ampligen Long COVID Development Program
18 Mai 2022 - 2:00PM
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 ongoing efforts to develop
an effective therapeutic for “Long COVID” with its investigational
drug, Ampligen.
Long COVID — also referred to as Post-COVID conditions by the
U.S. Centers for Disease Control and Prevention (CDC) — presents as
a wide range of health problems. The CDC’s current list of
Post-COVID conditions includes 18 different health issues.
Approximately one-half of these overlap with symptoms seen in
patients with Myalgic encephalomyelitis/chronic fatigue syndrome
(ME/CFS). SARS-related diseases have a history of inducing similar
symptoms (See: JAMA).
A Phase 3 prospective, double-blind, randomized,
placebo-controlled trial of rintatolimod (Ampligen) in ME/CFS
(AMP-516) produced objective improvement in exercise tolerance. An
analysis of a subset of patients in that trial with early onset of
symptoms showed a statistically significant 51.2% positive response
(p=0.003) (See: PLOS ONE).
In an amendment to its ongoing, FDA-authorized AMP-511 (See:
ClinicalTrials.gov) expanded access program (EAP), AIM enrolled
four post-COVID patients with new onset ME/CFS following acute
COVID-19. Following at least 12 weeks of Ampligen treatment, each
of these four patients indicated they had experienced a reduction
in fatigue, as measured via Patient-Reported Outcomes
questionnaires. A statistical analysis of these data indicated that
the decrease in fatigue compared to baseline was statistically
significant (p<0.003), despite the small number of patients.
Based in part on these early positive data, AIM is working
toward filing an 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. The newly
planned IND is for 12 weeks of therapy.
AIM Chief Medical Officer David Strayer, MD, stated: “AIM
believes these results are especially encouraging and justify
conducting a placebo-controlled study to attempt to confirm these
findings. Evidence from the AMP-516 study indicated that severe
ME/CFS patients with a shorter time from onset of ME/CFS symptoms
as a group responded better than those with a longer duration of
illness. Although the time scale is much more condensed, the
results from these four patients indicating improvement in fatigue
in only 12 weeks is consistent with the hypothesis that a shorter
duration of illness prior to treatment may improve responses to
Ampligen.”
Charles Lapp, MD, Principal Investigator for AMP-511 at
Hunter-Hopkins Center in Charlotte, N.C., stated: “Four subjects
with Long COVID — or Post-Acute Sequelae of Covid (PASC) — have
shown significant improvement in fatigue and their ability to be
active, as measured by an 11-point Likert scale. Three of the
four have also reported improvement in their post-exertion
malaise. The results have been so successful that two have
asked to continue Ampligen therapy. I have been very pleased
with these results and see potential for the therapeutic benefit of
Ampligen in other persons with Long COVID. I am excited to move
forward with a larger study of Ampligen for Long Haulers
(PASC).”
Oved Amitay, President and CEO of the advocacy organization
Solve M.E., stated: “Long COVID is a public health crisis and
patients are struggling to access safe and effective therapeutics.
We are encouraged that AIM ImmunoTech is engaging with the patient
communities to learn about their unmet needs. We are hopeful about
the potential of the drug Ampligen in Long COVID and ME/CFS. There
is a great interest in the study because drugs that combat viruses,
as well as affecting the immune system, could provide a significant
benefit to people with these post-infection diseases. The FDA must
work with drug developers and patient advocates to enable the rapid
initiation of these important studies on this and other promising
treatments.”
AIM CEO Thomas K. Equels stated: “While the recently published
positive data in pancreatic cancer, advanced recurrent ovarian
cancer and triple-negative breast cancer make Ampligen in oncology
a top priority, we remain dedicated in our efforts to develop an
effective therapy for ME/CFS and Long COVID. Millions of people
have suffered too long from these debilitating conditions, and we
are steadfast in our mission to help alleviate their
suffering.”
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. 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. 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 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.
Investor Relations ContactJTC Team, LLCJenene
Thomas833-475-8247AIM@jtcir.com
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