PRESS RELEASE : AIM ImmunoTech Inc: AIM ImmunoTech Announces Availability of the ME/CFS Clinical Trial of its Drug Ampligen for Enrollment to COVID-19 Long Haulers

 
 DGAP-News: AIM ImmunoTech Inc / Key word(s): Miscellaneous 
AIM ImmunoTech Inc: AIM ImmunoTech Announces Availability of the ME/CFS 
Clinical Trial of its Drug Ampligen for Enrollment to COVID-19 Long Haulers 
 
2020-12-24 / 14:15 
The issuer is solely responsible for the content of this announcement. 
 
*AIM ImmunoTech Announces that the ME/CFS Clinical Trial of its Drug 
Ampligen is Open for Enrollment to COVID-19 'Long Haulers'* 
 
_Institutional Review Board Authorizes Solicitation for Enrollment of 
Subjects_ 
 
*OCALA, FL / ACCESSWIRE / December 24, 2020 / *AIM ImmunoTech Inc. (NYSE 
American: AIM) announced today that the post-COVID-19 "Long Hauler" portion 
of the active AMP-511 Expanded Access Program [1] (EAP) protocol received 
approval from the Institutional Review Board (IRB) for a solicitation of 
patient enrollment. Patients in the trial are treated with AIM's flagship 
pipeline drug Ampligen. 
 
AIM announced in October [2] that the myalgic encephalomyelitis/chronic 
fatigue syndrome (ME/CFS) clinical trial received IRB approval to include 
patients previously diagnosed with SARS-CoV-2 - which causes the disease 
COVID-19 - but who now demonstrate post-acute infection chronic fatigue-like 
symptoms. These patients are commonly referred to as Long Haulers because of 
the persistence of their post-COVID-19 symptoms. 
 
Ampligen is AIM's TLR3 agonist immune-system modulator. It is approved in 
Argentina as the world's first therapy for severe Chronic Fatigue Syndrome 
and is the only late-stage drug in the U.S. development pipeline for ME/CFS. 
 
Long Haulers will be able to receive Ampligen treatments alongside the 
ME/CFS patients in the EAP. Up to 20 of the 100 active trial participants 
can be Long Haulers. The EAP is being conducted by Charles Lapp, MD, at 
Hunter-Hopkins Center in Charlotte, N.C., and Daniel Peterson, MD, at Sierra 
Internal Medicine in Incline Village, Nev. 
 
Enrollment is an important milestone in AIM's program to develop Ampligen as 
a therapy for the millions of people who medical experts predict will suffer 
from SARS-CoV-2-induced chronic fatigue, including many with brain fog. 
Nearly 70 million COVID-19 cases have been recorded during the ongoing 
global pandemic. Studies show that patients who recover from COVID-19 can 
report the persistence of symptoms (See: JAMA Network [3]). In addition, 
many survivors of the first SARS-CoV-1 epidemic in 2003 continued to report 
classic chronic fatigue-like symptoms after recovering from the acute 
illness. In fact, approximately 27% of survivors met the U.S. Centers for 
Disease Control and Prevention's criteria for chronic fatigue syndrome (See: 
JAMA Internal Medicine [4]). 
 
Given the massive pandemic caused by SARS-CoV-2, a virus almost identical in 
reference to pathogenesis to the first SARS virus, and the emerging 
literature supporting that COVID-19's SARS-CoV-2 induced chronic fatigue is 
following a similar pattern, the development of an effective therapy is a 
critical unmet public health need for patients where acute SARS-CoV-2 
infection-induced classic chronic fatigue symptoms. For more information, 
see AIM featured in _The Wall Street Journal_, "Long-Haul COVID Patients Put 
Hope in Experimental Drugs [5]." 
 
Dr. Lapp states, "It is anticipated that COVID-19 will trigger a large 
number 'long haulers' suffering COVID induced brain impairment and disabling 
fatigue. I believe the investigational immune-modulating antiviral drug 
Ampligen might have a role to play as a future therapy. I believe the data 
to date suggests that early treatment will lead to better levels of 
efficacy." 
 
Dr. Peterson states: "A hypothesis-based re-analysis of CFS patients treated 
with Ampligen in a randomized-controlled study showed that CFS patients with 
shorter duration of CFS symptoms were more than twice as likely to respond 
to Ampligen than the group as a whole. We are cautiously optimistic that 
early Ampligen treatment of post-COVID-19 patients with Long Hauler chronic 
fatigue will have the potential to induce a clinically beneficial outcome. 
This addition to the study will also allow longitudinal follow-up of 
clinical disease, as well as contribute to the investigation of pathogenesis 
and prognosis." (See: PLOS ONE [6]). 
 
AIM CEO Thomas K. Equels states: "While major global pharmaceutical 
companies have understandably focused their efforts on developing COVID-19 
vaccines, AIM believes there is an equally essential need to help 
post-COVID-19 patients who, while having recovered from the acute infection, 
may be suffering from long-term and debilitating COVID-induced chronic 
fatigue symptoms such as brain fog and disabling and profound 
post-exertional malaise. We hope that the treatment of 'Long-Hauler' 
patients in our AMP-511 clinical trial can help us to quickly determine 
whether Ampligen has potential as an important therapy for this 
post-COVID-19 syndrome. If successful, this may change millions of lives for 
the better." 
 
*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. 
 
*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. 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. 
Results obtained in animal models do not necessarily predict results in 
humans. No assurance can be given as to whether current or planned 
immuno-oncology clinical 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. 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. Some of 
the world's largest pharmaceutical companies and medical institutions are 
racing to find a treatment for COVID-19. Even if Ampligen proves effective 
in combating the virus, no assurance can be given that the Company's actions 
toward proving this will be given first priority or that another treatment 
that eventually proves capable will not make our efforts ultimately 
unproductive. The Company recognizes that all cancer centers, like all 
medical facilities, must make the pandemic their priority. Therefore, there 
is the potential for delays in clinical trial enrollment and reporting in 
ongoing studies in cancer patients because of the COVID-19 medical 
emergency. No assurance can be given that future studies will not result in 
findings that are different from those reported in the studies referenced. 
Operating in foreign countries carries with it a number of risks, including 
potential difficulties in enforcing intellectual property rights. We cannot 
assure that our potential foreign operations will not be adversely affected 
by these risks. 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, LLC 
Phone: [phone] 
Email: [e-mail] 
 
AIM ImmunoTech Inc 
Phone: [phone] 
Email: [e-mail] 
 
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December 24, 2020 08:15 ET (13:15 GMT)