Ampligen®

dsRNA Being Developed for Globally Important Cancers, Viral Diseases and Disorders of the Immune System

Ampligen is currently being used to treat pancreatic cancer patients in an Early Access Program (EAP) approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center and AIM has commenced a Phase 2 clinical study in locally advanced pancreatic cancer. The Company also has multiple ongoing clinical trials to evaluate Ampligen as a combinational therapy for the treatment of a variety of solid tumor types both underway and planned at major cancer research centers. Additionally, Ampligen is approved in Argentina for the treatment of severe chronic fatigue syndrome (CFS) and is currently being evaluated in many aspects of SARS-CoV-2/COVID-19 myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and Post-COVID Conditions.

Induces wide range of immunologic / antitumor activities 

Unique amongst known TLR agonists in its mechanism of action, specificity and safety profile

Only known TLR agonist to exclusively activate the TRIF adaptor and avoid the systemic inflammatory MyD88 pathway used by all other TLRs

Only known TLR3 agonist to avoid helicase activation of NF-κB. Natural dsRNAs and poly IC which activate NF-κB in the tumor microenvironment (TME) ↑Tregs and have the potential to enhance cancer cell proliferation

(Theodoraki, et al. 2018)

Broad Applicability Across:

Immune Disorders
Viral Diseases
Immuno-Oncology

Immune Disorders

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Viral Diseases

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Immuno-Oncology

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Ampligen® Has Significant Opportunity Across High-Value Multiple Disease Areas

~100,000 IV doses in humans, generally well-tolerated

Positive Phase 3 data generated in U.S. in treatment of ME/CFS.

Data from multiple in-vitro, preclinical (animal) models and clinical studies provide encouraging results in a range of potential clinical uses

Demonstrated safety and generally well tolerated across a number of clinical studies

Approved in Argentina for treatment of severe chronic fatigue syndrome

PD-1 and PD-L1 potential synergies with checkpoint inhibitors

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