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Hemispherx Biopharma Announces Collaboration with Millions Missing Canada....

Hemispherx Biopharma Announces Collaboration with Millions Missing Canada to Bring Medication to Canadians for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

PHILADELPHIA, Aug. 08, 2017 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE MKT:HEB) has announced that on Thursday, August 3, 2017 it participated in a meeting in Toronto, Canada with Canadian advocates for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). The meeting was lead by Millions Missing Canada and a Canadian physician representing Canadian patients with ME/CFS, in support of a collaborative effort to advance ME/CFS research and potential treatments in Canada. http://www.millionsmissingcanada.ca/links-and-resources/ This joint effort, which includes Dr. Ian Hyams, a leading physician specializing in ME/CFS management is the next step to bringing Ampligen® to Canadians suffering from the disease.

One year ago, Ampligen® became the first drug therapy approved in the world for ME/CFS, receiving government approval from the Republic of Argentina. Applications for Early Access Programs (EAP) in Europe and elsewhere are planned in the coming year. In the United States, Hemispherx has completed a pivotal Phase 3 clinical trial in ME/CFS, where it is the only late-stage drug in the pipeline for this disease. The U.S. FDA has advised that potential approval for commercial sale in the U.S. will require the conduct and review of a follow up confirmatory clinical trial. Ampligen® is also currently being used in patients with pancreatic cancer in an EAP in Europe.

Dr. Hyams is the medical director of the chronic fatigue and pain clinic in West Vancouver, British Columbia (“BC”), specializing in ME/CFS and fibromyalgia management as well as the management of similar disorders. Dr. Hyams is a consultant at the Complex Chronic Diseases Program at BC Woman’s Hospital in Vancouver and is a clinical instructor in the Department of Family Medicine at the University of British Columbia with responsibilities in the training of medical students and residents.
https://globenewswire.com/news-rele...cephalomyelitis-Chronic-Fatigue-Syndrome.html

@ScottTriGuy :thumbsup:
 

Dolphin

Senior Member
Messages
17,567
I remember when Dr Hyams had a private clinic in the UK around 2000. He was interested in offering Ampligen. He ended up moving to North America. What I heard* (not from him) was that it was said he might get in trouble with the General Medical Council in the UK which scared him off.

*There is a chance the information about the General Medical Council is incorrect
 
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Murph

:)
Messages
1,799
http://simmaronresearch.com/2016/06/making-case-ampligen-chronic-fatigue-syndrome-me/

Ampligen is an immunomodulator that targets a portion of the immune system that fights viruses....


Ampligen’s use in ME/CFS is predicated on the idea that viruses and/or immune issues are playing havoc in the disease. Ampligen is a toll -like receptor three (TLR-3) inducer. The receptor it binds to are found on antigen presenting cells such as dendritic cells that have been exposed to pathogens.


The binding of the receptor activates hundreds of genes in a cell. The side effects from most TLR inducing drugs limits their effectiveness, but Ampligen is unique among these drugs in that it does not cause cells to produce large amounts of pro-inflammatory cytokines.
 

ScottTriGuy

Stop the harm. Start the research and treatment.
Messages
1,402
Location
Toronto, Canada
We're excited by this prospect - no doubt it will be a tough row to hoe as Canada is known for its labyrinth approval process - but we have the highest ME rates in the world at 1.9%, so the need is great.

There is extra reason to fast track Ampligen by our Health Minister, as recent data indicates Ampligen has 50% efficacy for folks who have been sick with ME less then 8 years.

Thousands may prevented from permanent disability if action is taken quickly.

More info in our brand spanking new website:

http://millionsmissingcanada.ca/wp-content/uploads/2014/09/Key-Questions.pdf
 

Kati

Patient in training
Messages
5,497
The problem with Ampligen is that it is very expensive and that there needs doctors to safely infuse the drug within the health care system.

Here in Canada we have a socialized health care system. Optimally the drugs should be all covered and whenever the drugs require an infusion and a fair amount of nursing time, this needs to be covered for free.

If Ampligen gets approved as the only drug approved for Me in Canada, it creates the uncomfortable situation that it would cost a lot of money to our governments to indefinitely infuse this drug to patients who get better on it, or make patients pay for it which implies that our disease is actually not covered in Canada.

On a second topic, the enterovirus theory has not been proven and in fact when the CDC tried to replicate Dr Chia's work, they were unable to find what Chia found. Regardless, there is no treatment for enterovirus at the moment, so it's rather pointless to get stucked on one theory. I would rather have a researcher who is no fixed on one theory but remains open to going to the bottom of things and further the field through rigorous research using the most appropriate technology to achieve that.

At this point I would rather put my money on Davis team and Davis approach.

I would also insist that clinical trials and access to drugs and treatments (including but not limited to Ampligen) remain accessible to all Canadians regardless of their location, their ability to pay or duration of illness.
 

heapsreal

iherb 10% discount code OPA989,
Messages
10,089
Location
australia (brisbane)
The problem with Ampligen is that it is very expensive and that there needs doctors to safely infuse the drug within the health care system.

If the drug works and people return to work, they are then contributing to society through income tax etc so the real cost is alot less??

I think after the initial infusions and no adverse reactions occur, id think there should be technology now where people could do their own subcut infusions from home. Plus i wonder if low doses of frequency or some type of cycling of treatment eg 6 weeks and 6 weeks off could be considered after the initial 6 to 12 months of treatment and improvement have occurred.

It would be interesting to know the opinions of drs like dr peterson and kdm who have used it, what they think is the best way to maintain improvement/recovery with ampligen or do they think its best to stay on the same initial drug doses.

Its also possible if someone is a responder to antivirals, that if ampligen helps significantly, could antivirals or even immunovir, who shares some similar effects to ampligen, help one maintain improvements from initial ampligen treatment.

Im not 100% on this but i recall yrs back ampligen were looking into an oral version of the drug. Im not sure where that is at or probably research halted until infusions were approved??
 

Kati

Patient in training
Messages
5,497
Further insight into the Ampligen situation from dr Enlander on another thread:

Ampligen , made by Hemispherix, was researched by five groups including ourselves.Then, Hemispherix increased the price of the dose by 400% , we thought that this was outrageous and refused to co operate with the price increase. The results were not impressive in general, although certain patients had remarkable results. The were in the minority.

I can't find it again but someone mentioned 50% of patients improve on Ampligen. If you talk to the patients on Ampligen, they will tell you that the numbers are very optimistic and that only few are lucky enough to be recovered enough to return to work. I would not say no to a chance in improving and recovering a quality of life, however one needs to be realistic into their expectations in what the drug can do for them and how much it would cost them. As for every treatments out there, there will be responders, partial responders and non responders. Then there is the problem that FDA still has not approved it for ME.

Meanwhile, we are waiting for Cyclophosphamide and Rituximab climical trial results amd hopefully announcements of pilot study for 'cell danger response' treatment. It's good to keep the bigger picture in mind.
 

CFS_for_19_years

Hoarder of biscuits
Messages
2,396
Location
USA
I can't find it again but someone mentioned 50% of patients improve on Ampligen. If you talk to the patients on Ampligen, they will tell you that the numbers are very optimistic and that only few are lucky enough to be recovered enough to return to work. I would not say no to a chance in improving and recovering a quality of life, however one needs to be realistic into their expectations in what the drug can do for them and how much it would cost them. As for every treatments out there, there will be responders, partial responders and non responders. Then there is the problem that FDA still has not approved it for ME.
http://simmaronresearch.com/2015/11...verely-ill-chronic-fatigue-syndrome-patients/
Dr. Peterson gave Ampligen a strong endorsement stating that it’s the only therapy he’s seen in his three decades of work that’s been able to return ME/CFS patients to full health. He gets about a 70% response rate (not all of which get such strong results.)
Hemispherx Biopharma Announces Identification of High Responder Patient Subgroup from Ampligen® Phase III Trial in Patients with CFS/ME
http://ir.hemispherx.net/profiles/i...2599&GoTopage=1&Category=2178&BzID=2265&G=980
PHILADELPHIA, Oct. 31, 2016 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE:HEB) ("Hemispherx" or the "Company") announced today that a retrospective analysis of the AMP-516 Phase III trial of Ampligen® in patients with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), segmented primarily by disease duration, showed that 51% of Ampligen treated patients in a cohort with a disease duration of two to eight years vs. 18% of placebo patients demonstrated at least 25% improvement in placebo-adjusted exercise tolerance whereas the patient subset with less than two years or greater than eight years of disease duration failed to show a clinically-significant response.

The data analysis was presented at the 12th International IACFS/ME Research and Clinical Conference: Emerging Science and Clinical Care in Fort Lauderdale, FL, October 27-30, 2016.
 

ScottTriGuy

Stop the harm. Start the research and treatment.
Messages
1,402
Location
Toronto, Canada
The theory why the 'less than 2 years' subset 'failed to show a clinically-significant response' is because some folks spontaneously recover without treatment, enough in the placebo group to affect the data.

(I wonder if some of these 'spontaneous' recoverers are actually a relapse-remitting subgroup as I had 2 complete remissions.)

While in the 'greater than 8 years' subset response drops off after 8 years, there are still some strong responders, but evidently not enough to be 'clinically significant'.
 

Daffodil

Senior Member
Messages
5,875
hi all. I heard today that hemispherx is about to go bankrupt and that petersons ampligen IV clinic has been suspended pending some kind of review; apparently a neurologist in charge of the trials there screwed up somehow in her reporting or something...?

anyone else hear this?
 
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CFS_for_19_years

Hoarder of biscuits
Messages
2,396
Location
USA
Hemispherx Expands Ampligen Early Access Programme to Canada to Treat ME/CFS Patients
http://ir.hemispherx.net/profiles/i...ryID=87338&BzID=2265&g=980&Nav=0&LangID=1&s=0
Early Access Programs are Known as "Special Access Programmes" in Canada
@ScottTriGuy :thumbsup:
ORLANDO, Fla., April 04, 2018 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE American:HEB), focused on pharmaceutical research, said it amended its agreement with Netherlands-based myTomorrows to include management of a Special Access Programme (SAP) in Canada for patients suffering from Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

myTomorrows, Hemispherx's exclusive service provider for early access programs in Europe and Turkey, will now also perform special access activities in Canada to include managing the supply of Ampligen® for the treatment of ME/CFS, for which there is currently no approved product in Canada. Ampligen is approved only in Argentina for severe ME/CFS. Hemispherx has a NDA on file with the U.S. FDA and is developing a protocol for a confirmatory Phase 3 trial.

The first commercial size batch of Ampligen, which will contain ~8,300 vials, is anticipated to be available in May. This is the first of several lots scheduled over the next 18 months. We have recently received a stock order from myTomorrows for 2,100 vials that will be allocated from the first lot of Ampligen produced.

The Canadian SAP will be supported by Millions Missing Canada, a non-profit organization advocating for ME/CFS research funding and treatment access in Canada, which is working with Hemispherx to establish a pathway for government approval of Ampligen for ME/CFS in Canada.

"This is long overdue, and we are delighted myTomorrows is expanding its role with us into Canada to provide a greatly needed option for Canadians suffering the debilitating effects of ME/CFS," said Thomas K. Equels, CEO of Hemispherx. "Millions Missing Canada brings a strong advocacy and outreach to this program as an invaluable partner in advancing treatments for ME/CFS patients."

Scott Simpson, an ME patient and advocate with Millions Missing Canada said, "With over 580,000 Canadians diagnosed with ME, and experiencing the highest rates of unmet health care needs according to Health Canada, access to Ampligen is our greatest hope for treatment. For over 3 decades there have been millions of dollars missing from ME research and treatment in Canada, now Canadians living with ME may have a treatment option through the Special Access Program and we are keen to collaborate with Hemispherx and myTomorrows to make that opportunity become a reality. We may get our health, and lives, back."