Ampligen phase 3. Treatment Phase (12 weeks): Ampligen® and placebo will be administered via twice weekly infusions (Example: Monday/Thursday or Tuesday/Friday schedule) for 12 weeks. . In 2016, the University of Pittsburgh was sponsoring Phase I/II studies using Ampligen® as an adjunct treatment in ovarian, peritoneal, and colorectal cancer. Ampligen (poly I:poly C12U) is a mismatched double-stranded RNA (ribonucleic acid) with immodulatory and antiviral properties. in ME/CFS. In March 2012, the results from a phase-3 prospective, double-blind, randomised, placebo-controlled trial compared twice weekly IV rintatolimod (Ampligen) versus placebo. Earlier this year Hemispherx began supplying Ampligen® for pancreatic cancer patients in an Early Access Program (EAP) in the Netherlands. Only known TLR agonist to avoid the systemic inflammatory MyD88 pathway used by all other TLRs. [19][20] Hahnemann University and AIM ImmunoTech are collaborating on Phase II studies for Ampligen® as a single agent for renal cell carcinoma and melanoma. Because Ampligen has not yet been approved by the Food and Drug Administration (FDA), its use to date has been experimental. AIM ImmunoTech has reported positive initial pilot study data from its ongoing Expanded Access Program (EAP or AMP-511), a Phase III clinical trial of an investigational drug, Ampligen, for long Covid. Ampligen® is the only drug to have completed a Phase 3 clinical trial in the U. In further analyzing the results of AMP-518, AIM determined that, in this study, Ampligen-treated patients with Long COVID were, on average, able to walk farther in a Six-Minute Walk Test (“6MWT”) when compared to subjects who received a placebo. 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. Action is through the TRIF adaptor pathway. in treatment of ME/CFS. Jul 29, 2022 · Ampligen offered statistically significant improvements in chronic fatigue in post-Covid patients. The positive results of Aug 6, 2025 · Endometriosis The endometriosis abstract and presentation will be based on an analysis of data from AIM’s Phase 2 and Phase 3 clinical trials of Ampligen for the treatment of Chronic Fatigue Syndrome (“CFS”), which showed that a large percentage of female participants had significant comorbidity with endometriosis. 2018) Jul 28, 2022 · Additionally, Ampligen is currently being used to treat chronic fatigue patients and patients with Post-COVID condition of fatigue and AIM plans to initiate a Phase 2 clinical study in 2022. S. Jan 22, 2025 · AIM had previously reported positive topline results from its AMP-518 Phase 2 clinical trial. Positive Phase 3 data generated in U. Data from multiple in-vitro, preclinical (animal) models and clinical studies provide encouraging results in a range of potential clinical uses Ampligen continues to be evaluated, and as of May 2021 is the subject of phase 2 and phase 3 trials to potentially treat myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and several cancers. Ampligen is the only known TLR3 agonist to avoid helicase activation of NF-κB. In 1987 Ampligen was used experimentally in a small group of patients with AIDS (acquired immunodeficiency syndrome). Methods and findings: A Phase III prospective, double-blind, randomized, placebo-controlled trial comparing twice weekly IV rintatolimod versus placebo was conducted in 234 subjects with long-standing, debilitating CFS/ME at 12 sites. Ampligen is the only TLR3 agonist to avoid helicase activation of NF-κB. bwajfglgetisxhiccukqblbhpcwiakwzhjschwsemx