AIM ImmunoTech Announces Filing of Provisional Patent Application for Use of Ampligen as Both an Intranasal and an IV Therapy for Post-COVID-19 Cognitive Dysfunction (PCCD)

AIM ImmunoTech Announces Filing of Provisional Patent Application for Use of Ampligen as Both an Intranasal and an IV Therapy for Post-COVID-19 Cognitive Dysfunction (PCCD)

Patients with symptoms of PCCD being treated with Ampligen in the ongoing AMP-511 Early Access Program have reported consistent improvements in cognitive function

OCALA, Fla., Aug. 25, 2021 — AIM ImmunoTech Inc. (NYSE American: AIM) today provided an update on the company’s efforts to develop its drug Ampligen as a potential intranasal therapeutic for COVID-19, including the announcement of a new provisional patent application for Ampligen as both an intranasal and an intravenous therapy for what AIM describes as Post-COVID-19 Cognitive Dysfunction (PCCD).

AIM has been working steadily to expand its COVID-19 patent portfolio. In addition to the new provisional patent application addressing compositions and methods for treating PCCD, in February 2020 the company filed multiple COVID-19-related provisional patient applications, which are now patent pending worldwide, for Ampligen as a COVID-19 therapy and as a vaccine adjuvant. Developing an effective therapy is critical for relieving the socioeconomical impact of PCCD and its medical burden on the population. The people suffering from PCCD, including some young adults, are afflicted with severe difficulties in concentrating, serious memory problems and inability to live an active lifestyle, unable to work, and even unable to perform everyday tasks.

Early data has demonstrated that patients with symptoms of PCCD being treated with Ampligen in the ongoing AMP-511 Early Access Program (EAP) have reported improvements in cognitive function, according to Charles Lapp, MD, at Hunter-Hopkins Center in Charlotte, N.C.

“The results of some individual symptoms are very dramatic,” said Lapp, the EAP’s lead investigator. “The results clearly show a significant reduction of one or more symptoms of PCCD in patients after the administration of Ampligen.”

Also, as recently noted in the Wall Street Journal, intranasal immunity to the SARS-Cov-2 virus may be a key to controlling the spread of COVID-19, especially the more contagious and deadly Delta variant, which can accumulate in nasal tissues even in individuals who have been vaccinated with currently available vaccines. AIM’s leadership and scientific experts reached a similar conclusion in the early days of the COVID-19 outbreak, deciding then to make the development of intranasal Ampligen a major R&D goal.

“There is a growing and significant need for effective therapies to treat COVID-19, both in the acute phase and its longer-term effects,” said AIM CEO Thomas K. Equels. “We believe that Ampligen has the potential to activate the body’s innate immune system to fight COVID-19 through its use as a front-line, early-onset therapeutic – which includes potentially reducing intranasal viral load, potentially curbing the spread of the disease and lessening its severity. We believe Ampligen also can play a role in treating Post-COVID-19 Cognitive Dysfunction. PCCD is one of the most common and disabling immediate after effects of acute COVID-19 infection.”

AIM’s approach has been strategic and methodical:

·     In August 2020, AIM identified an effective in vitro model using human tracheal, bronchial epithelial cells at The Institute for Antiviral Research at Utah State University which showed that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels.

·     In November 2020, AIM disclosed positive pre-clinical results from a test by Japan’s National Institute of Infectious Diseases (NIID) This pre-clinical work determined that Ampligen, when used as a vaccine adjuvant, provided 100% survival in a pre-clinical rodent model of SARS-CoV as a surrogate model of SARS-CoV-2, in contrast to the control group, which demonstrated 100% mortality. The preclinical findings suggested Ampligen was generally well-tolerated by the experimental cohort.

·     In early 2021, AIM launched a Phase 1 intranasal safety study of Ampligen, testing the safety, tolerability and biological activity of Ampligen at increasing doses, in anticipation of testing its potential as an intranasal therapy. A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with Ampligen given at four escalating dosages across four cohorts, to a maximum level of 1,250 micrograms. In June 2021, AIM announced that there were no Severe Adverse Effects observed in the study at any dosage level, thus establishing that Ampligen was well-tolerated when administered intranasally in humans.

·     A June 2021 article in the medical journal Cancers stated that Ampligen has the potential to reduce the severity of COVID-19 by “activating the innate and the adaptive immune systems by activating a cascade of actions in human pancreatic cancer cells.” The study’s authors include Prof. C.H.J. van Eijck, MD, PhD, the lead investigator for an Early Access Program at Erasmus Medical Center in the Netherlands, where Ampligen is being used to treat patients with late-stage pancreatic cancer.

·     In July 2021, AIM announced significant progress toward a Phase 2a Human Challenge Trial to test the intranasal prophylactic effect of Ampligen in separate Rhinovirus hRV and Influenza cohorts. The study is part of AIM’s work to develop Ampligen as a potential therapy against SARS-CoV-2 and other respiratory viruses. The trial is expected to commence in Q4 2021.

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. 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.