Ampligen (rintatolimod) is an immunomodulatory double-stranded RNA drug intended primarily for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). It has limited approval geography and remains experimental in the United States. Development has focused on immune modulation and innate immune activation pathways.
AIM ImmunoTech partners with Thermo Fisher to design Phase 3 trial for Ampligen in pancreatic cancer, while Innovent Biologics begins dosing patients in Phase 3 study of IBI354 for HER2-positive breast cancer.
AIM ImmunoTech outlined key milestones for its Phase 2 DURIPANC trial evaluating Ampligen combined with durvalumab in metastatic pancreatic cancer, with primary endpoint evaluation expected in December 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT01312389 |
A Clinical Trial of Autologous Oxidized Tumor Cell Lysate Vaccine For Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer |
TERMINATED | PHASE1/PHASE2 |
| NCT00215800 |
The Study of the Safety and Efficacy of Ampligen in Chronic Fatigue Syndrome |
COMPLETED | PHASE3 |
| NCT00002269 |
A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen |
COMPLETED | NA |
| NCT00001000 |
A Study of Atvogen in Healthy Volunteers and HIV-Infected Patients Who Have No Symptoms of Infection |
COMPLETED | NA |
| NCT00000735 |
A Clinical Trial To Evaluate the Toxicity and Antiviral Effects of a Range of Doses of Ampligen in p24 Antigen Positive HIV-Infected Patients With AIDS or ARC |
COMPLETED | PHASE1 |
| NCT00000713 |
A Phase I Clinical Trial To Evaluate the Toxicity, Antiviral and Immunomodulatory Effects of a Range of Doses of Ampligen in HIV-Infected Subjects |
COMPLETED | PHASE1 |
