Ampligen for ME/CFS

"Hemispherx to Present at the 30th Annual ROTH Conference

ORLANDO, Fla., March 05, 2018 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc.(NYSE American:HEB), focused on pharmaceutical research, announced today that it will be presenting at the 30th Annual ROTH Conference on Monday, March 12th at 5:30PM PT in Green - Salon 3 (the time may be subject to changes depending on the conference organizers) at the Ritz Carlton in Dana Point, California.

The Company webcast can be found at http://wsw.com/webcast/roth32/heb/ following the presentation on March 12th.

Thomas K. Equels, M.S. J.D., Chief Executive Officer of Hemispherx Biopharma, will be presenting as well as meeting with investors one-on-one.

Mr. Equels' presentation will focus on ME/CFS (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome), immuno-oncology, and immune system amplification for enhanced viral vaccines."

https://www.nasdaq.com/press-releas...he-30th-annual-roth-conference-20180305-00595

 

I've just registered. I hope this link works for everyone.

http://wsw.com/webcast/roth32/heb/index.aspx

 

Unfortunately it won't let me download the slides. To gain access all you need to do is add your name and email address and I put company name as "patient".

To be honest the lecture wasn't that informative and not all specific to ME (discussing other clinical uses as well). The main points were (most of which is known already):

- It is well-tolerated and has a good safety profile with over 100,000 IV doses given
- It has broad spectrum antiviral activity by acting as a TLR3 agonist and is immunomodulatory
- Ampligen enjoys orphan drug status for ME
- For ME, an NDA filed with the FDA but a confirmatory phase 3 trial is required in the US before approval. They're in the process of designing a phase 3 trial and negotiating the terms of that trial.
- It's approved in Argentina for ME. The first drug approved for ME anywhere in the world. Although it's not commercially available quite yet.

 

Hemispherx Successfully Completes Production of More Than 8,500 Vials of Ampligen for Commercial Sales and Expanded Clinical Programs

https://globenewswire.com/news-rele...ial-Sales-and-Expanded-Clinical-Programs.html

 

@Barry

 

Has anyone here ever been on Ampligen?

 

Here in the US, the FDA will allow only 100 people to use it at any given time. It is all out of pocket and the cost of the drug has gone from $25k a year to $45k over the last couple of years. That is just for the drug and does not include the infusion costs. But I hear it makes a huge difference.

Whether it is actually working on a virus deeply embedded in our nerve tissue or not no one knows. There is a drug I am on for inflammatory arthritis which is an old malaria drug, Hydroxychloroquine, that helps with the pain and inflammation. It is believed that the immune system processes are activated with arthritis but not due to a virus although this viral drug works. So it could be the same with Ampligen; we just don't know if there is a virus or not.

 

Hemispherx to Present at the 8th Annual LD Micro Invitational

"ORLANDO, Fla., May 10, 2018 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE American:HEB) announced today that it will be presenting at the 8th Annual LD Micro Invitational on Monday, June 4 at 11:00 AM PT (the time may be subject to changes depending on the conference organizers) at the Luxe Sunset Boulevard Hotel in Bel Air, California."

"Thomas K. Equels, M.S. J.D., Chief Executive Officer of Hemispherx, will be presenting and meeting one-on-one with investors. Mr. Equels’ presentation will focus on immuno-oncology, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and immune system amplification for enhanced viral vaccines. Mr. Equels will discuss the completed production of a commercial size batch (~8,500 vials) of Ampligen for the company’s Early Access Programs for patients with Pancreatic Cancer and ME/CFS, as well as expanded clinical programs."

full article here:
https://globenewswire.com/news-rele...-at-the-8th-Annual-LD-Micro-Invitational.html

 

Hemispherx BioPharma : Releases First 8,500 Vial Lot of Ampligen to Supply Expanded Access Programs in the United States, Europe and Canada

"The first commercial-sized lot of Ampligen, which completed cGMP manufacturing on April 4, 2018, has passed all required testing for regulatory release for human use. These 8,500 vials are earmarked for distribution to United States based Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) expanded access programs in Nevada and North Carolina, United States clinical trials in immuno-oncology, European expanded access programs and for certain testing and validation required for commercial launch in Argentina.

The company also reported that its cGMP contract manufacturer successfully filled and finished a second commercial-size batch production run of roughly 8,000 vials. This is the second such successful commercial sized production run in the last two months. This second commercial sized lot is currently undergoing regulatory testing for human use, a roughly two-month process."

http://www.4-traders.com/HEMISPHERX...-to-Supply-Expanded-Access-Programs-26795848/

 

If they mean cyclic guanosine monophosphate it may help.

The immune modulator levamisole I use increases cGMP.

 

cGMP = Current Good Manufacturing Practices

 

Hemispherx Opens FDA-Approved Reimbursement Based Expanded Access Treatment Program for ME/CFS to New Enrollees at Approved Clinical Sites in Nevada and North Carolina

"We view the compassionate care program as just a band aid for a much larger problem. We estimate over one hundred thousand people are now fully disabled in the United States due to ME/CFS. This incapacitating unmet medical need should be aggressively addressed by providing therapeutic options, just as the FDA did when it successfully addressed the AIDS crisis years ago," said Thomas K. Equels, Chief Executive Officer of Hemispherx.

http://ir.hemispherx.net/profiles/i...ryID=87984&BzID=2265&g=980&Nav=0&LangID=1&s=0

 

What's the update on Ampligen? Are people getting Ampligen in Nevada and North Carolina? How does one get Ampligen in Nevada or North Carolina? Is it working? Can a person get Ampligen in Argentina or Europe?

Thanks

 

From today's PR:

In parallel, we continue to pursue Ampligen for the treatment of severe myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Ampligen is approved for this indication in Argentina (the first and only meaningful therapy approved anywhere in the world for ME/CFS) and is available through an U.S. Food and Drug Administration (FDA) authorized expanded access program (EAP), AMP-511, a program where the FDA has approved the reimbursement rate of $200 per vial for the direct costs and where we are expanding participation at clinics in Nevada and North Carolina.

Today's PR was mostly focused on their oncology program... which is their best shot at becoming a viable company. Treatment in Argentina begins at the end of this year - they expect 3 patients by years end. re: Europe, you need to check with MyTomorrows to be sure, but I think ampligen is only available to pancreatic cancer patients at this time.

 

3 patients only?

 

Dec. 17, 2018 (GLOBE NEWSWIRE) --

Hemispherx Biopharma, Inc. (NYSE American: HEB), an immuno-pharma R&D and emerging commercial growth company focused on unmet medical needs in immunology, recently met with clinical patients at Hunter-Hopkins Center in Charlotte, N.C. undergoing treatment for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

https://globenewswire.com/news-rele...nded-Access-Program-in-the-United-States.html

 

Can somebody tell me if this is still by IV? I would love to do it but I cannot TrackR twice a week 3h to go get it. Does anybody know what the current protocol is?

 

Yes, by IV. It’s a large molecule drug, so it’s doubtful that will ever change.

 

That AMP-511 is a compassionate treatment protocol that’s been available for 20 years. FDA wants one more large trial. Argentina has approved.