Anonymous
Not logged in
Talk
Contributions
Create account
Log in
Search
Editing
Ampligen
(section)
From MEpedia, a crowd-sourced encyclopedia of ME and CFS science and history
Namespaces
Page
Discussion
More
More
Page actions
Read
Edit
Edit source
History
Warning:
You are not logged in. Your IP address will be publicly visible if you make any edits. If you
log in
or
create an account
, your edits will be attributed to your username, along with other benefits.
Anti-spam check. Do
not
fill this in!
==Evidence== ===Coxsackie B=== In a mouse model, AmpligenĀ® was found to be protective of [[Coxsackie B3]]-induced [[myocarditis]].<ref name="Padalko,2004" /> ===HHV6=== *1994, A study done by the Department of Biochemistry, Temple University School of Medicine, Philadelphia, using IV therapy of AmpligenĀ® "resulted in a significant decrease in [[Human herpesvirus 6]] activity (P < .01) and in downregulation of the 2-5A synthetase/[http://me-pedia.org/wiki/Ribonuclease_L RNase L] pathway in temporal association with clinical and neuropsychological improvement."<ref name="Suhadolnik,1994" /> ===Efficacy in ME/CFS=== *1995, Long Term Improvements in Patients with Chronic Fatigue Syndrome Treated with AmpligenĀ®<ref name="Strayer,1995" /> *2001, Chronic Fatigue Syndrome, Ampligen, and Quality of Life: A Phenomenological Perspective<ref>{{Cite journal | last = Snell | first = Christopher R. | author-link = Christopher Snell | last2 = Stevens | first2 = Staci R. | author-link2 = Staci Stevens | last3 = Vanness | first3 = J. Mark | author-link3 = Mark VanNess | date = Jan 2001 | title = Chronic Fatigue Syndrome, Ampligen, and Quality of Life: A Phenomenological Perspective | url =http://www.tandfonline.com/doi/full/10.1300/J092v08n03_11 | journal = Journal of Chronic Fatigue Syndrome|language=en | volume = 8 | issue = 3-4 | pages = 117ā121|doi=10.1300/J092v08n03_11|issn=1057-3321|pmc=|pmid=|access-date=|quote=|via=}}</ref> * 2004, A study done at the Rega Institute for Medical Research, Belgium on [[coxsackie B3]] virus-induced myocarditis in C3H/HeNHsd mice show AmpligenĀ® markedly reduced the virus titers in the normalized heart electrocardiographic parameters<ref name="Padalko,2004" /> *2012, A double-blind, placebo-controlled, randomized, clinical trial of the [[TLR3|TLR-3]] agonist rintatolimod in severe cases of chronic fatigue syndrome<ref name="Strayer, 2012" /> *2012, Hemispherx Biopharma (now AIM ImmunoTech) presented several studies on efficacy at a [[U.S. Food and Drug Administration|US Food and Drug Administration]] (FDA) meeting:<ref name="HemBio,2012" /> ::The increase of baseline in mean exercise tolerance tests (ETT) improved 95.7% in the group on AmpligenĀ® and 28.2% in the placebo group. (p value= 0.047; slide 81)<ref name=":1">{{Cite journal | last = Strayer | first = David R. | last2 = Carter | first2 = William A. | last3 = Stouch | first3 = Bruce C. | last4 = Stevens | first4 = Staci R. | last5 = Bateman | first5 = Lucinda | last6 = Cimoch | first6 = Paul J. | last7 = Lapp | first7 = Charles W. | last8 = Peterson | first8 = Daniel L. | last9 = Chronic Fatigue Syndrome AMP-516 Study Group| date = 2012 | title = A double-blind, placebo-controlled, randomized, clinical trial of the TLR-3 agonist rintatolimod in severe cases of chronic fatigue syndrome | url =https://www.ncbi.nlm.nih.gov/pubmed/22431963 | journal = PloS One | volume = 7 | issue = 3| pages = e31334|doi=10.1371/journal.pone.0031334|issn=1932-6203|pmc=3303772|pmid=22431963}}</ref> ::A greater percentage of AmpligenĀ® patients (68.0%) decreased their use of concomitant medications used in an attempt to palliate symptoms of CFS compared to the placebo group (54.6%). (slide 59)<ref name=":1" /> ::No Evidence for induction of autoantibodies with AmpligenĀ® by assessment of Anti-dsDNA and Rheumatoid Factor in 64 randomly selected patients in controlled study AMP-516 at week 32; In the placebo group, 0% developed Anti-dsDNAand one patient (3.7%) developed Rheumatoid Factor autoantibodies. (slide 54) *2015, Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME): Characteristics of Responders to Rintatolimod<ref name="Strayer, 2015" /> :See [[Ampligen Exercise Tolerance - graph 1]] | last4 *2015, [[David Strayer]], et al., published "Low NK Cell Activity in Chronic Fatigue Syndrome (CFS) and Relationship to Symptom Severity," in the ''Journal of Clinical & Cellular Immunology.'' The study reviewed previous studies that concluded that the more decreased the Natural Killer cell cytotoxicity was in patients, the greater the CFS severity. The study, also, reported that ''in vitro'' exposure of peripheral blood mononuclear cells from CFS patients (fulfilling both the [[Centers for Disease Control and Prevention|CDC]] 1988 and 1994 case definitions) to AmpligenĀ® increased Natural Killer cell cytotoxicity 100-178%.<ref name=":3">{{Cite journal | last = Scott | first = Victoria | author-link = | last2 = Strayer | first2 = David | author-link2 = David Strayer | date = 2015 | title = Low NK Cell Activity in Chronic Fatigue Syndrome (CFS) and Relationship to Symptom Severity | url = http://www.omicsonline.org/open-access/low-nk-cell-activity-in-chronic-fatigue-syndrome-cfs-and-relationship-to-symptom-severity-2155-9899-1000348.php?aid=59415 | journal = Journal of Clinical & Cellular Immunology|language=en | volume = 06 | issue = 04| pages=|doi=10.4172/2155-9899.1000348|issn=2155-9899|pmc=|pmid=|access-date=|quote=|via=}}</ref> *2016, [[William Mitchell|William M. Mitchell]] published a review in the journal, ''Expert Review of Clinical Pharmacology'' that stated: "Rintatolimod has achieved statistically significant improvements in primary endpoints in Phase II and Phase III double-blind, randomized, placebo-controlled clinical trials with a generally well tolerated safety profile and supported by open-label trials in the United States and Europe." Mitchell is the Chairman of the Board for AIM ImmunoTech and a Professor of Pathology, Microbiology and Immunology at Vanderbilt University School of Medicine, Nashville, Tennessee.<ref name=":4">{{Cite journal | last = Mitchell | first = William M | author-link = William Mitchell | date = 2016-06-02 | title = Efficacy of rintatolimod in the treatment of chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) | url = http://www.tandfonline.com/doi/full/10.1586/17512433.2016.1172960 | journal = Expert Review of Clinical Pharmacology|language=en | volume = 9 | issue = 6 | pages = 755ā770|doi=10.1586/17512433.2016.1172960|issn=1751-2433|pmc=4917909|pmid=27045557|access-date=|quote=|via=}}</ref>
Summary:
Please make sure your edits are consistent with
MEpedia's guidelines
.
By saving changes, you agree to the
Terms of use
, and you irrevocably agree to release your contribution under the
CC BY-SA 3.0 License
and the
GFDL
. You agree that a hyperlink or URL is sufficient attribution under the Creative Commons license.
Cancel
Editing help
(opens in new window)
Navigation
Navigation
Skip to content
Main page
Browse
Become an editor
Random page
Popular pages
Abbreviations
Glossary
About MEpedia
Links for editors
Contents
Guidelines
Recent changes
Pages in need
Search
Help
Wiki tools
Wiki tools
Special pages
Page tools
Page tools
User page tools
More
What links here
Related changes
Page information
Page logs