Nice! This gives more information. Here's regarding the doctors takes. They recently lobbied the FDA to hold a two day meeting to find a way to bring Ampligen forward. They are definitely behind this drug.
"In context, this clear statistical improvement corroborates our independent clinical experts, who indicate that they have also identified criteria predictive of responsiveness to our experimental drug Ampligen®", states Tom Equels, President of Hemispherx.
PHILADELPHIA, Sept. 21, 2015 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE MKT:HEB) announces the publication of an online peer reviewed research article of an analysis of clinical data on its investigational therapeutic, Ampligen, entitled, "Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME); Characteristics of Responders to Rintatolimod" in the current issue of
Journal of Drug Research and Development. The team of authors is composed of Hemispherx staff, consultants and leading independent clinical experts in CFS/ME in the United States.
Data from a previous Phase III clinical trial of Ampligen in patients with CFS/ME were retrospectively analyzed to determine whether baseline exercise tolerance (ET) could be used to predict responses to Ampligen (rintatolimod) vs. placebo. A modified Bruce ET treadmill test was used because of the severe physical exercise intolerance of CFS patients.
Analysis of significant improvement in exercise performance at the ≥ 25% and ≥ 50% levels using ET at 40 weeks compared to baseline was performed for the intent-to-treat (ITT) population (n=208) using a baseline exercise threshold ET of greater than 9 minutes. For this subset of patients with baseline ET >9 minutes, 33% of patients on Ampligen®, an experimental therapeutic, vs. 12% of patients on placebo improved ET duration by ≥ 25% (p=0.004) while 23% of Ampligen® treated patients improved by ≥ 50% compared to 4.5% placebo patients (p=0.003).
A continuous responder analysis provided further support for a significant clinical enhancement in the ET effect in the Ampligen® cohorts as compared to placebo.
The Karnofsky Performance Score (KPS) and Vitality (SF-36 subscale) quality of life secondary endpoint also demonstrated similar clinically significant improvements for the cohort of study subjects with baseline ET > 9 minutes, as a function of the same ET parameters. Importantly, these improvements, the 10 point increase in KPS and 14.6 point increase in vitality scores, are both considered by the authors to r
eflect clinically significant changes that represent objective improvement in the quality of life. Ampligen®, an experimental therapeutic, also reduced deterioration in ET compared to placebo in patients who failed to improve physically.
Taken in context with the recent peer reviewed publication pointing to reduced NK function in CFS/ME patients, (entitled "Low NK Cell Activity in Chronic Fatigue Syndrome (CFS) and Relationship to Symptom Severity" in which 17 studies were reviewed that evaluated NK cell cytotoxicity (NKCC) data and the relationship to different CFS case definitions and CFS disease severity,
Journal of Clinical and Cellular Immunology (Strayer D,
et al,
J Clin Cell Immunol2015;6:4
http://doi.org/10.4172/2155-9899.1000348), a new set of evidence based criteria have now been identified which may assist in selection of CFS/ME patients who may derive significant benefit clinically from therapeutic intervention with selective TLR-3-dsRNA activators.
"In context, this clear statistical improvement corroborates our independent clinical experts, who indicate that they have also identified criteria predictive of responsiveness to our experimental drug Ampligen®", states Tom Equels, President of Hemispherx.
![ME/CFS lecture | Dr Nancy Klimas | 2011 [Chronic Fatigue Syndrome / SEID / New Zealand] - YouTube](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)
