OCALA, Fla., Sept. 20, 2021 (GLOBE NEWSWIRE) — AIM ImmunoTech Inc. (NYSE American: AIM) today provided a status update on its Phase 2a Human Challenge Trial (HCT) to test the company’s drug Ampligen as a potential intranasal prophylactic therapy using a human rhinovirus (HRV-16, a common cold virus) and influenza A virus (H3N2). The proposed protocol for the AIM-sponsored study was submitted to the Oxford Research Ethics Committee (REC)/Medicines and Healthcare Regulatory Agency (MHRA) on September 10, 2021. A meeting is scheduled to review the study on September 24, and the response is expected by mid November.
In addition, AIM and hVIVO continue to work to finalize the details of a Clinical Trial Agreement (CTA) and hope to announce its signing soon. hVIVO is a subsidiary of Open Orphan plc, a rapidly growing specialist contract research organization and world leader in vaccine and antiviral testing using human challenge clinical trials.
The study should move forward quickly once we have the expected approval of the REC/MHRA and our final agreement with hVIVO.
The Phase 2a HCT is a single center, prospective, randomized, double-blind, placebo-controlled study of Ampligen administered intranasally to healthy adult male and female participants. In an HCT, subjects are intentionally exposed to particular diseases to test how the diseases will respond to potential therapeutics. An HCT will allow AIM to expedite the development process for Ampligen by ensuring full exposure of both the control group and the Ampligen group, so as to assess whether there is a prophylactic effect. A total of 64 participants are planned to participate in this study; 32 participants will be randomized and inoculated with influenza A/Perth/16/2009 (H3N2) and 32 participants will be randomized and inoculated with HRV-16 for an estimated total of 64 evaluable participants. In each group, 16 participants will be receiving Ampligen and 16 participants will be receiving placebo.
A successful Phase 2a study could also help establish Ampligen as a potential prophylaxis against future viral variants and future novel respiratory viruses for which there are no current therapies, as well as known viruses such as SARS-CoV-2, which causes COVID-19.
AIM CEO Thomas K. Equels, commented, “We are excited to advance this Human Challenge Trial using Ampligen. Assuming we are successful, we believe this trial could have significant implications in the fight against infectious, viral respiratory diseases and future pandemics. Specifically, there is a major unmet need for a prophylactic therapy that could be easily administered to patients prior to exposure to respiratory viruses such as influenza, coronaviruses and even rhinoviruses such as the common cold. We look forward to partnering with hVIVO on this landmark trial.”
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 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. No assurance can be given as to whether the REC will approve the proposed protocol or require revisions and, while AIM and hVIVO believe that they are in the final stages of completing the CTA, no assurance can be given that the CTA will be finalized. 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.
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