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Hemispherx Enters into Agreement for Early Access Program for Ampligen in Europe

CFS_for_19_years

Hoarder of biscuits
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USA
http://www.hemispherx.net/content/investor/default.asp?goto=833

Hemispherx Enters into an Agreement with myTomorrows for an Early Access Program for Rintatolimod in Europe

Philadelphia, PA, Monday, August 10, 2015: Hemispherx Biopharma, Inc. (NYSE MKT: HEB) (the “Company” or “Hemispherx”), reported today that it has executed an agreement with Impatients, N.V., a Netherlands based company doing business as myTomorrows, for the commencement and management of an Early Access Program (EAP) in all of Europe and Turkey.

myTomorrows, as Hemispherx’ exclusive service provider in Europe and Turkey, will perform EAP activities in Europe and Turkey to include the supply of rintatolimod for the treatment of Chronic Fatigue Syndrome (CFS) to patients with an unmet medical need.

Govert Shouten, Ph.D, Co-Founder & CBO at myTomorrows, said “Rintatolimod for CFS fits perfectly with the raison d'être of myTomorrows. CFS affects as many people in Europe as in the US and there is no drug approved anywhere specifically for CFS. In clinical trials rintatolimod has shown promising results for certain CFS patients particularly those most severely affected.

As we do with other life-threatening and debilitating diseases such as cancer, MS, and depression, myTomorrows will set up and roll out the early access programs needed to help these patients
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A.B.

Senior Member
Messages
3,780
If I remember right, the results for this drug were unimpressive - or am I mistaken?
 

Ecoclimber

Senior Member
Messages
1,011
You are mistaken I think. Some people in double blinds 20+ years ago had great results.

This is great news. I'd kill for ampligen in th US

Ha, Ha I'd think that would defeat your long term prognosis.

As in normal cases for ME/CFS a subset were responders and some were not. Without clear cut biomarkers it is hard to determine who would be a responder. This is why Fluge and Mella are being so careful in their Phase II trial.
 

Sushi

Moderation Resource Albuquerque
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19,935
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What the hell does this mean? Are they giving it away? Trials?

PE
AMPLIGEN SOON AVAILABLE IN THE EUROPEAN UNION

Hemispherx also announced today that a Netherlands-based company called myTomorrows will be supplying Ampligen to some Chronic Fatigue Syndrome patients with “unmet medical need” through the Early Access Program (EAP).
[/URL]
 

CFS_for_19_years

Hoarder of biscuits
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2,396
Location
USA
What the hell does this mean? Are they giving it away? Trials?
AVAILABLE SOON IN EUROPE
AMPLIGEN SOON AVAILABLE IN THE EUROPEAN UNION

Hemispherx also announced today that a Netherlands-based company called myTomorrows will be supplying Ampligen to some Chronic Fatigue Syndrome patients with “unmet medical need” through the Early Access Program (EAP).

I know as much as you do:

Thomas K. Equels, Executive Vice Chairman and CFO of Hemispherx said “We are very pleased to be collaborating with myTomorrows to provide rintatolimod under these unique Early Access Programs. Not only will this collaboration create the possibility for physicians to use rintatolimod under certain circumstances, myTomorrows will collaborate with these physicians to capture data on patients treated and such data may add to our other efforts to gain full regulatory approval in Europe, Latin America, Australia, New Zealand as well as the U.S. and elsewhere.”

About myTomorrows
myTomorrows provides patients that are excluded from clinical trials access to drugs in development. They focus on disease areas with unmet needs; oncology, neurology, psychiatry and rare diseases. myTomorrows identifies the latest developments in drugs and facilitates requests for access to these drugs in development.
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
Ha, Ha I'd think that would defeat your long term prognosis.

As in normal cases for ME/CFS a subset were responders and some were not. Without clear cut biomarkers it is hard to determine who would be a responder. This is why Fluge and Mella are being so careful in their Phase II trial.
This is the issue Responders tend to be helped a lot. Non-responders were not, hence the description. Nobody knew, then at least, who would wind up in each group.

Currently we do not know for sure who the responders and non-responders will be in Rituximab either, but the response rate and effect size are high.
 

Denise

Senior Member
Messages
1,095
I do not find Ampligen or rintatolimod listed in a search on the myTomorrows site.
https://mytomorrows.com/
It is possible they haven't yet updated the site to reflect an agreement with Hemispherix.

I would like to know more details about the rumored significant Ampligen price hike for US patients.
 

Battery Muncher

Senior Member
Messages
620
I don't know anything about Ampligen. Is there an article/blog post that quickly summarises the results of previous trials?

Is it currently used in any countries (USA etc)?
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
Ampligen has been a hot topic for use for decades. Its an old old drug that has never been approved, but many patients go into something like temporary near remission while on it. Its a game changer for responders. Its also not cheap. I am not aware of any succinct accurate discussions of it. Its complicated and messy, and spans decades.
 

halcyon

Senior Member
Messages
2,482
Is there an article/blog post that quickly summarises the results of previous trials?
Nothing I've seen that quickly summarizes it. As Alex points out, it has a long and storied past. The recent AHRQ treatment review looked at two trials and had this to say:

Rintatolimod, an investigational intravenous immune modulator and antiviral drug, improved measures of exercise performance compared with placebo in 2 fair-quality trials (n = 324) enrolling severely disabled adults (improved cardiopulmonary exercise test tolerance, 36.5% versus 15.2%, P = 0.047; improved exercise duration, 10.3% versus 2.1%, P = 0.007; improved exercise work, 11.8% versus 5.8%, P = 0.01) (low strength of evidence) (21, 27). The clinical implications of these changes are unclear. One of these 2 trials also reported improvement in measures of function (activities of daily living and Karnofsky Performance Scale score) (21), and the other indicated a reduction in use of other medications to relieve CFS symptoms (27). Attrition ranged from 9% to 19% and adherence, from 83% to 91%.

Is it currently used in any countries (USA etc)?
I believe some patients in the US are still receiving this drug, out of pocket at great expense.
 

dannybex

Senior Member
Messages
3,561
Location
Seattle
As in normal cases for ME/CFS a subset were responders and some were not.

I know it's literally been a lifesaver for Mary Schweitzer just as one example, but here's a report from a few who were in the original trial who weren't too happy with both Ampligen and how the trial was conducted:

http://www.ncf-net.org/forum/ampligeninPink.htm

http://www.ncf-net.org/forum/fall-vol12-3-2.htm

Given Hemispherx's checkered past, I wouldn't be surprised if the doubling in price here is linked to the lowered cost in Europe.
 
Messages
15,786
What the hell does this mean? Are they giving it away? Trials?
Most Dutch people would be somewhat shocked at the thought of paying for prescription drugs, even cheap ones. So I'm guessing it'll be free in either event, either covered by the manufacturer, insurance, or the government.
 

taniaaust1

Senior Member
Messages
13,054
Location
Sth Australia
If I remember right, the results for this drug were unimpressive - or am I mistaken?

Definitely mistaken, this drug got some very severe ME people out of their wheelchairs and able to walk again. There was an outcry as some ME people fought to stay on this drug when the drug trials ended , some experienced the horror of declining right back to their previous very severe states without this drug. (I think if Im recalling correctly, one lost her ability to even talk again after they stopped the trial and the drug).

This is one of two drugs I'd really like to be able to try which I feel has some hope of maybe even curing me due to what I've read on it and those it helped.

This news if it goes ahead where some ME/CFS people can access it is huge.
 
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Daffodil

Senior Member
Messages
5,875
not sure how this differs from the canadian program of emergency drug release, under which ampligen has been available since 1996. no doctor will prescribe it though, so its impossible to get.
 

taniaaust1

Senior Member
Messages
13,054
Location
Sth Australia
There is far better stories written on patient 0 which tells of her amazing improvement with this drug.. for those wondering about those it can help.. here's one quick story.

"
Patient Zero
In early 1990, this reporter interviewed Ampligen "Patient Zero," Nancy Kaiser, who described her life before Ampligen. Kaiser first became ill from what would turn out to be Chronic Fatigue Syndrome in the late 1970s. From being a very athletic person who played golf four times a week and went swimming every morning, Kaiser was transformed into some who could not even walk the golf course because of a painful, burning sensation in her feet and legs. She also developed a strange constellation of symptoms: a rash on her eyelids, impaired vision, disturbed thought processes, chronic bladder and yeast infections, and chronic pelvic pain.

"Various doctors told me I was going through an early menopause, I was upset because my children were growing up, I had an unhappy marriage," Kaiser recalls. "None of it was true. I was sick."

After years of unsatisfactory and unhelpful medical treatments (including an unnecessary hysterectomy), Kaiser finally found Dr. Daniel Peterson, one of the physicians who had identified the first outbreak of CFS in Incline Village, Nevada, in 1984.

"Dr. Peterson told me, 'You're not crazy. You're very, very sick.' He was the first doctor who didn't think I had a psychiatric illness," Kaiser now says.

Peterson, with the help of Senator Pete Domenici, lobbied the FDA to release Ampligen to treat Kaiser under a compassionate care plea. In 1988, FDA granted the request, and HEM Pharmaceuticals (the precursor to Hemispherx) supplied Kaiser with Ampligen at no charge for several years.

While waiting for the FDA to act, Kaiser became deathly ill. By the time Ampligen was available to her, she was having 12-15 seizures every day. She couldn't walk; "I had to crawl," she says. Kaiser couldn't even feed herself when she finally traveled to Incline Village to be treated with Ampligen by Peterson.

"Three months after the first treatment, I could go home to my husband. I have had no infections at all since I started getting Ampligen," Kaiser said in 1990. "I never had any serious side effects -- just slight chills and occasional nausea while getting the drug [intravenously]."

Kaiser's astonishing response to Ampligen convinced the FDA to allow Peterson to conduct the first, 15-person clinical trial of Ampligen in CFS patients. Kaiser herself credits the drug with saving her life. "
http://wwcoco.com/cfids/ampligen2.html