Treadmill test shows who Ampligen may help

Drug company research team identifies which CFS patients may respond best to Ampligen
Hemispherx Biopharma has identified new criteria to see which CFS patients may get significant clinical benefit from Ampligen (rintatolimod). Patients who are able to complete more than 9 minutes of exercise (modified Bruce protocol exercise tolerance test) are likely to benefit from Ampligen.
Data from a previous Phase III clinical trial of Ampligen were analysed to determine whether baseline exercise tolerance could be used to predict responses to Ampligen  vs. placebo in CFS patients. A modified treadmill test was used because of the severe physical exercise intolerance of CFS patients. The paper uses both 1988 Holmes criteria and 1994 Fukuda criteria to define CFS patients.
For patients with baseline exercise tolerance of more than 9 minutes, 33% of patients on Ampligen improved exercise tolerance duration by 25% or more (vs. 12% of patients on placebo), while 23% of Ampligen-treated patients improved by 50% or more (compared to 4.5% placebo patients).
There was also a group of patients identified who, although termed ‘non responders’, had their deterioration slowed by taking Ampligen.
What prompted this research?
This study was prompted by the Phase III clinical trial, where patients were given Ampligen twice weekly for 40 weeks compared to placebo. Some patients dramatically responded while others did not. Their hypothesis was that baseline exercise tolerance could be used to predict responses to rintatolimod. This report identifies three classes of patients. The first is defined by marked improvement in exercise tolerance and quality of life. The second class was not significantly responsive. The third class, although deteriorating on rintatolimod, do so at a reduced rate compared to controls.
Full paper: Published in the Journal of Drug Research and Development, the paper is Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME): Characteristics of Responders to Rintatolimod.
 

Facebook
Twitter
WhatsApp
Email

Latest News

blue rectangle image with the NIH logo in the top left hand corner. the words: NIH MECFS Research Roadmap Update Public comments open until March 8th appear in the middle of the image. the meaction logo is in the bottom right hand corner.

NIH ME/CFS Research Roadmap Update–Public Comment Period Now Open

The NIH ME/CFS Research Roadmap public comment period is open now with a deadline of March 8th.  #MEAction is a member of the ME/CFS Research Roadmap Working Group and for the past several months we have been advocating on behalf of this community within this group. Our Executive Director, Laurie Jones, served on the nervous

Read More »
a rectangle image with multiple small hearts in the corners. The words, Valentine's Day Interview with Jamison Hill and Book Promotion. The cover of the book is next to the words. The #MEAction logo at the bottom.

Valentine’s Day Interview with Jamison Hill & Book Promotion

We are excited to bring you a special Valentine’s Day promotion of Jamison Hill’s most recent book, Something’s Wrong with Micah.  #MEAction had the pleasure of having a Twitter chat with Jamison when his memoir When Force Meets Fate came out. We now get to bring this Q&A about his newest book to you. Jamison

Read More »
on a red sparkly rectangle image. The words "#MEAction's Volunteer Program Revamped!" are written in an arcade/game font. Sign-Up Today! The #MEAction logo in the bottom right corner

#MEAction’s Volunteer Program Revamped

Exciting news: #MEAction revamped our volunteer program for the new year! We are honored to have wonderful volunteers including people with ME, Long Covid, and other associated conditions as well as our caregivers, allies, and wider communities. Volunteering with #MEAction can and does make all the difference. We invite you to join our program! Our

Read More »
Scroll to Top