AIM ImmunoTech Announces Clinical Trial Agreement for a Phase 2a Human Challenge Trial of Ampligen as a Potential Intranasal Prophylaxis Against Respiratory Viruses
30 September 2021 - 8:00PM
AIM ImmunoTech Announces Clinical Trial Agreement for a Phase 2a
Human Challenge Trial of Ampligen as a Potential Intranasal
Prophylaxis Against Respiratory Viruses
AIM ImmunoTech Inc. (NYSE American:AIM) today announced that AIM
and hVIVO have a signed Clinical Trial Agreement (CTA) for a Phase
2a Human Challenge Trial (HCT) to test the company’s drug Ampligen
as a potential intranasal prophylactic using a human rhinovirus
(HRV-16, a common cold virus) and influenza A virus (H3N2).
This antiviral study will be conducted by hVIVO, a subsidiary of
Open Orphan plc (AIM: ORPH), a rapidly growing specialist
pharmaceutical services clinical research organization and world
leader in vaccine and antiviral testing using human challenge
clinical trials. The AIM-sponsored study is expected to start in Q4
2021.
AIM announced on September 20 that the proposed protocol for the
study had been submitted to the Oxford Research Ethics
Committee/Medicines and Healthcare Regulatory Agency. The committee
met last week and its response is expected by mid November.
Preparations to commence the study are now underway, pending the
expected approval.
The Phase 2a HCT is a single center, prospective, randomized,
double-blind, placebo-controlled study of Ampligen administered
intranasally to healthy adult male and female participants. In an
HCT, subjects are intentionally exposed to particular diseases to
test how the diseases will respond to potential therapeutics. An
HCT will allow AIM to expedite the development process for Ampligen
by ensuring full exposure of both the control group and the
Ampligen group, so as to assess whether there is a prophylactic
effect. A total of 64 participants are planned to participate in
this study; 32 participants will be randomized and inoculated with
influenza A/Perth/16/2009 (H3N2) and 32 participants will be
randomized and inoculated with HRV-16 for an estimated total of 64
evaluable participants. In each group, 16 participants will be
receiving Ampligen and 16 participants will be receiving
placebo.
hVIVO has two decades of experience and expertise in safely
conducting challenge studies across a range of respiratory viruses,
including various strains of Influenza, Respiratory Syncytial Virus
(RSV) and human Rhinovirus HRV (common cold virus), malaria,
asthma. In October 2020, this expanded to include the
SARS-CoV-2 virus.
A successful Phase 2a study could also establish Ampligen as a
potential prophylaxis against future viral variants and future
novel respiratory viruses for which there are no current therapies,
as well as mutations of known viruses such as SARS-CoV-2, which
causes COVID-19.
Further, exploratory endpoints are designed to develop data
related to Ampligen’s potential ability to confer enhanced and
expanded immunity post-infection.
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.
About Open Orphan plc
Open Orphan plc (London and Euronext: ORPH) is a
rapidly growing contract research company that is a world leader in
testing vaccines and antivirals using human challenge clinical
trials. The Company provides services to Big Pharma, biotech and
government/public health organisations.
Open Orphan runs challenge studies in London from both
its 19-bedroom Whitechapel quarantine clinic and its
state-of-the-art 24-bedroom QMB clinic with its highly specialised
on-site virology and immunology laboratory. The Company has a
leading portfolio of human challenge study models for infectious
and respiratory diseases and is developing a number of new models.
There has been an explosion in the growth of the infectious disease
market, which is estimated to grow to in excess
of $250bn by 2025. The Group is focused on refreshing its
existing challenge models and develop new models, such as Malaria,
to address the dramatic growth potential of the global infectious
disease market.
Building upon its many years of challenge studies and virology
research, the Company is developing an in-depth database of
infectious disease progression data. Based on the Company's Disease
in Motion® platform, this unique dataset includes clinical,
immunological, virological and digital (wearable) biomarkers. The
Disease in Motion platform has many potential applications across a
wide variety of end users including big technology, wearables,
pharma and biotech companies.
Open Orphan's Paris office has been providing
biometry, data management and statistics to its many European
pharmaceutical clients for over 20 years. For over 15 years, the
Company's Netherlands office has been providing drug
development consultancy and services, including CMC (chemistry,
manufacturing and controls), PK and medical writing, to a broad
range of European clients. Both offices are now also fully
integrated with the London office and working on
challenge study contracts as well as supporting third party
trial contracts.
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. No assurances can be given as to
whether any studies will be successful or yield favorable data.
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 effective in the treatment of respiratory viruses,
including SARS-CoV-2, as an intranasal therapy or otherwise, and no
assurance can be given that this will be the case. There is the
potential for delays in clinical trial enrollment and reporting
because of the COVID-19 medical emergency. We do not undertake to
update any of these forward-looking statements to reflect events or
circumstances that occur after the date hereof.
Contacts:
Crescendo Communications, LLCPhone:
212-671-1021Email: aim@crescendo-ir.com
AIM ImmunoTech IncPhone:
800-778-4042Email: IR@aimimmuno.com
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