AIM ImmunoTech announces the filing of a provisional patent

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OCALA, Fla., Aug.25, 2021 (GLOBE NEWSWIRE) – AIM ImmunoTech Inc. (NYSE American: AIM) today provided an update on the company’s efforts to develop its drug Ampligen as a potential intranasal treatment for COVID-19, including the announcement of a new provisional patent application for Ampligen as intranasal and intravenous therapy for what AIM describes as post-COVID-19 cognitive dysfunction (PCCD).

AIM regularly works to expand its COVID-19 patent portfolio. In addition to the new provisional patent application for compositions and treatment methods for PCCD, in February 2020 the company filed several provisional patient applications related to COVID-19, which are now patent pending worldwide. whole, for Ampligen as a COVID-19 therapy and as a vaccine adjuvant. The development of an effective therapy is essential to alleviate the socio-economic impact of PCCD and its medical burden on the population. People with PCCD, including some young adults, suffer from severe difficulty concentrating, severe memory problems and inability to lead an active lifestyle, unable to work, and even unable to perform daily tasks.

Early data demonstrated that patients with symptoms of PCCD treated with Ampligen under the ongoing AMP-511 early access program (EAP) reported improvements in cognitive function, according to Charles Lapp, MD, at Hunter -Hopkins Center in Charlotte, NC

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

Also, as recently stated in the the Wall Street newspaper, 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 build up in nasal tissues even in people who were vaccinated with currently available vaccines. AIM’s management and scientific experts came to a similar conclusion at the start of the COVID-19 epidemic, deciding 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 Thomas K. Equels, CEO of AIM. “We believe Ampligen has the potential to activate the body’s innate immune system to fight COVID-19 through its use as a first-line, early-onset treatment – potentially including burden reduction. viral intranasal, potentially spreading the disease and decreasing its severity. We believe that Ampligen may also play a role in the treatment of post-COVID-19 cognitive dysfunction. PCCD is one of the most common and disabling immediate effects of acute COVID-19 infection. “

AIM’s approach has been strategic and methodical:

  • In August 2020, AIM identified an efficient in vitro model using human tracheal and bronchial epithelial cells at the Institute for Antiviral Research at Utah State University, which showed that Ampligen was able to reduce blood cells by 90%. Infectious viral yields of SARS-CoV-2 at a clinically feasible level. intranasal doses of Ampligen.
  • In November 2020, AIM disclosed the positive preclinical results of a test from the Japan National Institute of Infectious Diseases (NIID). SARS-CoV model as a surrogate model for SARS-CoV-2, unlike the control group, which demonstrated 100% mortality. Preclinical results suggested that Ampligen was generally well tolerated by the experimental cohort.
  • In early 2021, AIM initiated 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 a intranasal therapy. A total of 40 healthy subjects received either Ampligen or placebo in the trial, with Ampligen given in four escalating doses over four cohorts, up to a maximum level of 1250 micrograms. In June 2021, AIM announced that no serious adverse effects were observed in the study at any dosage level, establishing that Ampligen was well tolerated when administered intranasally in humans. .
  • An article from June 2021 in the medical journal Cancers said Ampligen has the potential to reduce the severity of COVID-19 by “activating the innate and adaptive immune systems by activating a cascade of actions in human pancreatic cancer cells.” Authors of the study include Professor CHJ van Eijck, MD, PhD, principal investigator for an early access program at Erasmus Medical Center in the Netherlands, where Ampligen is used to treat patients with pancreatic cancer at an advanced stage.
  • In July 2021, AIM announced significant progress towards 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 begin in the fourth quarter of 2021.

About AIM ImmunoTech Inc.

AIM ImmunoTech Inc. is an immunopharmaceutical company focused on researching and developing therapies to treat several types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

Caution

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 referring to 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 these statements, the Company claims safe harbor protection for the forward-looking statements contained in the PSLRA. No guarantee can be given as to whether any studies will be successful or give favorable data. Studies and trials are subject to many factors, including lack of regulatory approval (s), no study drug, or a shift in priorities in institutions sponsoring other trials. Significant additional testing and testing will be needed to determine whether Ampligen will be effective in treating respiratory viruses, including SARS-CoV-2, as intranasal therapy or otherwise, and no assurance can be given that this will be the best. case. There is a risk of delay in recruitment and notification of clinical trials due to the COVID-19 medical emergency. We do not undertake to update these forward-looking statements to reflect events or circumstances that occur after the date hereof.

Contacts:

Crescendo Communications, LLC
Telephone: 212-671-1021
Email: [email protected]

AIM ImmunoTech Inc
Telephone: 800-778-4042
Email: [email protected]


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