OCALA, Fla., March 22, 2021 (GLOBE NEWSWIRE) -- AIM
ImmunoTech Inc. (NYSE American: AIM) today announced that the
Institutional Review Board (IRB) of Roswell Park Comprehensive Cancer
Center (Roswell Park) has approved a protocol amendment to Roswell
Park’s ongoing Phase 1/2a study evaluating the two-drug combination of
AIM’s Ampligen and interferon alpha-2b as a potential early-onset
treatment for patients with cancer and mild-to-moderate COVID-19.
The
IRB-approved amendment calls for randomization of an additional twenty
patients. Ten of these patients will receive a single dose of Ampligen,
but no interferon treatment, and the other ten will receive best
available care only. Ampligen alone has a generally well-tolerated
safety profile with lower risk of adverse events than is generally
expected with interferon therapy.
"We are excited to see
Ampligen tested not only as part of an antiviral treatment combination
for COVID-19 among cancer patients, but also as a possible standalone
therapy for this terrible virus,” said AIM CEO Thomas K. Equels. “An
early-onset treatment is especially critical for cancer patients, who
face significantly increased risk of severe symptoms or death."
AIM previously announced in November 2020
that the first patient had been enrolled and received treatment in
Roswell Park’s study. Funding for the clinical trial is provided, in
part, through grants from the National Cancer Institute and AIM, as well
as institutional support from Roswell Park.
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.
Cautionary Statement
This
press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. 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.
These statements involve a number of risks and uncertainties. For
example, significant additional testing and trials will be required to
determine whether Ampligen will be effective in the treatment of
COVID-19 in humans and no assurance can be given that it will be the
case. In this regard, the Roswell Park Clinical Trial Agreement is one
of the first steps and no assurance can be given as to whether the
Roswell Park trial and/or subsequent trials will prove successful. Some
of the world’s largest pharmaceutical companies are racing to find a
treatment for COVID-19. Even if Ampligen proves effective in combating
the virus, no assurance can be given that our actions toward proving
this will be given first priority or that, even if Ampligen proves
effective, another treatment that eventually proves effective will not
make our efforts ultimately unproductive. No assurance can be given that
future studies will not result in findings that are different from
those reported in studies the Company is relying on. Operating in
foreign countries carries with it a number of risks, including potential
difficulties in enforcing intellectual property rights. The Company
cannot assure that its potential foreign operations will not be
adversely affected by these risks. With regard to the Company’s
activities with Ampligen generally, no assurance can be given as to
whether current or planned trials will be successful or yield favorable
data and the 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. In addition, initiation of
planned clinical trials may not occur secondary to many factors
including lack of regulatory approval(s) or lack of study drug. Even if
these clinical trials are initiated, the Company cannot assure that the
clinical studies will be successful or yield any useful data or require
additional funding. Any forward-looking statements set forth herein
speak only as of the date of this press release. The Company does not
undertake to update any of these forward-looking statements to reflect
events or circumstances that occur after the date hereof. The
information found on the Company’s website is not incorporated by
reference herein and is included for reference purposes only.
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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