AIM ImmunoTech Files Provisional Patent Application for Ampligen as an Early-Onset Intranasal Therapy that May Also Confer Enhanced Immunity to a Wide Range of Respiratory Viruses
OCALA, Fla., Sept. 27, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) today announced the filing of a provisional patent application for Ampligen as a potential early-onset intranasal therapy designed to enhance and expand infection-induced immunity, epitope spreading, cross-reactivity and cross-protection in patients exposed to a wide range of RNA respiratory viruses, such as influenza, Rhinoviruses and SARS-CoV-2, which causes the disease COVID-19.
The new filing concerns the early-stage administration of Ampligen following active viral replication after a respiratory virus has entered a person's nasal passages. AIM believes that Ampligen - which is thought to be a powerful immune system modulator - can help the body respond to such an infection by first activating the innate immune system to blunt viral replication, and then, as a second important step, inducing an enhanced cross-protective immune response or a broad-based immune response, both to the virus and potential variants of the virus.
Applications for clinical trial authorization, which the Company plans to file in the near future, are expected to include intranasal therapeutic effect as a primary endpoint, but also exploratory endpoints to gather data supporting the Ampligen-enhanced immunity.
"We have designed upcoming clinical trials with exploratory endpoints that we believe will provide data supporting this novel concept and further validate Ampligen's potential as an early-onset intranasal therapy," said AIM CEO Thomas K. Equels. "When vaccines are not available, or where no vaccine has been developed, this therapy would use the power of the virus against the virus. From a public health perspective, this may be a critical new concept, especially for future novel viral outbreaks where no vaccine has been developed. This approach builds on the strong existing data demonstrating Ampligen's broad antiviral activity against a range of respiratory viruses, combined with the encouraging results from our recently completed Phase 1 clinical trial to assess the safety, tolerability and biological activity of Ampligen as a potential intranasal therapy, which determined that the highest-dosage and the every other day frequency of administration of intranasal Ampligen was generally well-tolerated."
AIM's COVID-19 patent portfolio also includes:
A provisional patent application for Ampligen as both an intranasal and an intravenous therapy for what AIM describes as Post-COVID-19 Cognitive Dysfunction (PCCD).
Multiple provisional patient applications for Ampligen as a COVID-19 therapy and as an intranasal COVID-19 vaccine adjuvant.
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.
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 assurance can be given as to when the Company will submit the applications for clinical trial authorization, whether the applications will be required to be revised or whether they will be approved. Even if the applications are approved, they are only the initial steps. 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. In addition, no assurance can be given that the patent application described above or subsequent patent applications claiming priority to this application ultimately will be granted. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.