AIM ImmunoTech Inc (NYSE:AIM) said it has submitted a provisional patent application for Ampligen as a potential early-onset intranasal therapy.
This therapeutic use is 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 coronavirus (COVID-19).
According to AIM, 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.
READ: AIM ImmunoTech advances bid to study Ampligen as therapy for Post-COVID-19 Cognitive Dysfunction
“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,” said the company.
Additionally, the company plans to file applications for clinical trial authorization in the near future. These trials 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,” CEO Thomas K. Equels, said in a statement.
The company executive went on to note that Ampligen could be used when vaccines are not available, or where no vaccine has been developed, as the therapy uses, “the power of the virus against the virus.”
Equels added: “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 new potential treatment approach builds on the strong existing data demonstrating Ampligen’s broad antiviral activity against a range of respiratory viruses, and compliments the results of the recently completed Phase I clinical trial to assess the safety, tolerability and biological activity of Ampligen as a potential intranasal therapy.
The data determined that the highest-dosage and every other day frequency of administration of intranasal Ampligen was generally well-tolerated, the company stated.
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.
The immuno-pharma company is also focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases.
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