Hemispherx Biopharma Reports Ampligen Boost NK Cell Functioning

Cort

Founder of Health Rising and Phoenix Rising
Staff member
Good news for Ampligen! (It could use some....) It was a small study but there were pretty big increases in NK cell functioning.

Encouragingly it does say that "further clinical studies are now underway in the U.S. to evaluate the interrelationships between CFS disease severity, dysfunction of NK cells, and therapeutic response to Ampligen®, an experimental biotherapeutic."....What Ampligen really needs is more data: hopefully this will provide it and it will be on its way to FDA approval...
Hemispherx Biopharma Reports Low NK Cell Activity in Chronic Fatigue Syndrome (CFS) and Relationship to Disease Symptom. By GlobeNewswire, September 15, 2015, 08:30:00 AM EDT

Ampligen(R) Increases NK Activity More Than 100% in Vitro in a CFS Patient Population
PHILADELPHIA, Sept. 15, 2015 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE MKT:HEB) announced today the publication in the current issue of the peer reviewed Journal of Clinical and Cellular Immunology (Strayer D, et al, J Clin Cell Immunol 2015;6:4 http://doi.org/10.4172/2155-9899.1000348) an article 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.
NK cells are an important component of the human immune response acting as a surveillance mechanism against invading pathogens and tumor cells. The review includes evidence that there is an association between decreased NK cell activity and increased CFS symptomatology.

New data was also reported in this publication, of in vitro exposure of peripheral blood mononuclear cells (PBMCs) from 15 CFS patients (mean average age 47.5 years and median age 46.1 years, 67% are female). These data indicated than in vitro treatment with Ampligen®, an experimental biotherapeutic, produced a 178% increase in mean NK activity (NKCC) and a 100% increase in median NK activity (NKCC). Patients in the study meet both the 1988 and 1994 case definitions of CFS as advanced by the Centers for Disease Control (CDC).

Further clinical studies are now underway in the U.S. to evaluate the interrelationships between CFS disease severity, dysfunction of NK cells, and therapeutic response to Ampligen®, an experimental biotherapeutic.

Read more: http://www.nasdaq.com/press-release/hemispherx-biopharma-reports-low-nk-cell-activity-in-chronic-fatigue-syndrome-cfs-and-relationship-20150915-00461#ixzz3mKRVWt00
 

tandrsc

Well-Known Member
Last edited:

Cort

Founder of Health Rising and Phoenix Rising
Staff member
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 reflect 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.
 

tandrsc

Well-Known Member
Hello...may I ask what doses you are using of each. ...Thank You.
Mistletoe: I make a mug of tea (300ml) with one teabag (I think this is about 2 level tsp). After pouring on boiling water, I let it steep until cool and then take out the teabag and keep in the fridge. I add 2 tbsp (30ml) to some of my drinks throughout the day so that I've used it all after 2 days. You can experiment with dose by making stronger/weaker tea or taking it more/less often.

Ashwagandha: I take 1/8 tsp a day. I mix it with a spoon of honey and cocoa powder and eat it off the spoon.

I take all my herbals in one of the above ways. You can see my full list at http://www.cortjohnson.org/blog/2013/08/11/an-herbal-approach-to-chronic-fatigue-syndrome-that-worked/

I also saw a video on nutritionfacts.org recently that said cardamom and black pepper might also help.
http://nutritionfacts.org/video/boosting-natural-killer-cell-activity/
 

ScottTriGuy

Active Member
If you're looking for something that's cheaper and easier to increase your NK cell function, there are a few studies on Pubmed to show that Mistletoe and Ashwangandha can do that (I take both).

What has your experience been with those 2?

Side effects? Dosage?

Thanks.
 

tandrsc

Well-Known Member
These two are my "subtle" helpers. They don't help with any particular symptom, but I noticeably wilt if I stop taking them.

I haven't experienced any side effects, but I take quite small amounts.
 

Joyful1

Member
Mistletoe: I make a mug of tea (300ml) with one teabag (I think this is about 2 level tsp). After pouring on boiling water, I let it steep until cool and then take out the teabag and keep in the fridge. I add 2 tbsp (30ml) to some of my drinks throughout the day so that I've used it all after 2 days. You can experiment with dose by making stronger/weaker tea or taking it more/less often.

Ashwagandha: I take 1/8 tsp a day. I mix it with a spoon of honey and cocoa powder and eat it off the spoon.

I take all my herbals in one of the above ways. You can see my full list at http://www.cortjohnson.org/blog/2013/08/11/an-herbal-approach-to-chronic-fatigue-syndrome-that-worked/

I also saw a video on nutritionfacts.org recently that said cardamom and black pepper might also help.
http://nutritionfacts.org/video/boosting-natural-killer-cell-activity/
Thank you so much for sharing this information!
 

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