This antiviral study will be conducted by hVIVO, a subsidiary of
A successful Phase 2a study could also 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.
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 high infection rates for subjects who receive the drug, therefore also ensuring large data sets with potentially statistically significant results.
This Phase 2a study will come in the wake of AIM's recent announcement that all subjects have completed treatment in the company's Phase 1 clinical study to assess the safety, tolerability and biological activity of Ampligen as a potential 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. The study reported no Severe Adverse Events at any dosage level. A final study report is expect in the third quarter of 2021.
Unlike other drugs tailored to combat specific diseases, Ampligen targets and amplifies the natural immune system pathways that fight viruses, meaning that Ampligen delivered via an intranasal device could be an effective preventive therapy for people who may be exposed to, or have recently been exposed to, a respiratory virus such as influenza, or even common coronaviruses and rhinoviruses (like the common cold). Success against these common viruses could also indicate that an Ampligen prophylaxis could help blunt the spread of infection from lethal coronaviruses, as well as other serious viruses. This Phase 2a study will test this proposition in humans.
AIM CEO
An Ampligen prophylaxis could potentially benefit vulnerable populations who are at increased risk of transmission due to their environments, such as hospital workers; people on cruise, cargo or military ships; people on commercial airplanes; and service personnel in close quarters on military installations.
About
About
Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company's Disease in Motion platform, this unique dataset includes clinical, immunological, virological and digital (wearable) biomarkers. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma and biotech companies. Following COVID-19 there is now a renewed interest and investment in infectious diseases.
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.
Contact:
Phone: 212-671-1021
Email: aim@crescendo-ir.com
Phone: 800-778-4042
Email: IR@aimimmuno.com
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