Ampligen: Effect of disease duration in a randomized Phase III trial of rintatolimod, an immune modulator for ME/CFS (Strayer et al. 2020)

Pyrrhus

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Effect of disease duration in a randomized Phase III trial of rintatolimod, an immune modulator for ME/CFS (Strayer et al. 2020)

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0240403
Excerpt:
Background
Rintatolimod is a selective TLR3 agonist, which has demonstrated clinical activity for ME/CFS in Phase II and Phase III double-blind, placebo-controlled, randomized, multi-site clinical trials.

Methods and findings
A hypothesis-based post-hoc analysis of the Intent to Treat (ITT) population diagnosed with ME/CFS from 12 independent clinical sites of a Phase III trial was performed to evaluate the effect of rintatolimod therapy based on disease duration. The clinical activity of rintatolimod was evaluated by exercise treadmill tolerance (ETT) using a modified Bruce protocol. The ITT population (n = 208) was divided into two subsets of symptom duration. Patients with symptom duration of 2–8 years were identified as the Target Subset (n = 75); the remainder (<2 year plus >8 year) were identified as the Non-Target Subset (n = 133). Placebo-adjusted percentage improvements in exercise duration and the vertical rise for the Target Subset (n = 75) were more than twice that of the ITT population. The Non-Target Subset (n = 133) failed to show any clinically significant ETT response to rintatolimod when compared to placebo. Within the Target Subset, 51.2% of rintatolimod-treated patients improved their exercise duration by ≥25% (p = 0.003) despite reduced statistical power from division of the original ITT population into two subsets.

Conclusion/significance
Analysis of ETT from a Phase III trial has identified within the ITT population, a subset of ME/CFS patients with ≥2 fold increased exercise response to rintatolimod. Substantial improvement in physical performance was seen for the majority (51.2%) of these severely debilitated patients who improved exercise duration by ≥25%. This magnitude of exercise improvement was associated with clinically significant enhancements in quality of life. The data indicate that ME/CFS patients have a relatively short disease duration window (<8 years) to expect a significant response to rintatolimod under the dosing conditions utilized in this Phase III clinical trial. These results may have direct relevance to the cognitive impairment and fatigue being experienced by patients clinically recovered from COVID-19 and free of detectable SARS-CoV-2.
Press release:
https://finance.yahoo.com/news/aim-immunotech-announces-plos-one-140000119.html
 

bensmith

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I guess a step in the right direction. I wonder why it hasnt been approved.

And this is physical more so then mental?
 

Pyrrhus

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I guess a step in the right direction. I wonder why it hasnt been approved
They have been trying to get it approved for over 30 years, but I guess the results don't look very impressive on paper.

Feel free to search this forum for "Ampligen" and you'll find a long history behind this drug...
 

Pyrrhus

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Yeah im reading that now, that is insane. I thought these results looked good in this study.
Some people improve on Ampligen, but not everyone. This paper suggests that people who have been sick less than eight years have a better chance of responding to Ampligen.

I believe that Ampligen is currently approved only in Argentina.