Ampligen Takes Big Step Forward - Becomes First Drug Approved Anywhere For Chronic Fatigue Syndrome

[jsuzor]

Annual projected drug cost $41,600 per year?

If you speak with Nancy McGrory again, please ask her why the have not kept in touch with those of us who were study participant's. I called them a few years after the study to see if I needed to update my address, and they were not interested in me. Thanks for your post.

 

[Jeremy C.]

I would really be surprised if it didn't work better in people who were less ill; it seems the sicker you get the harder this is to treat.

I would disagree with that. I was on a small trial in Australia where my doctor put the sickest of his patients on the Ampligen. I had been completely bedridden for four years, unable to tolerate sound or light and unable to digest food. Constant night sweats, fevers, whole digestive system covered in ulcers; every time I moved my heart would palpitate. My doctor was worried I was going to die. Six months on Ampligen and I started to improve. After about a year, I was going for walks outside, which is more than I can do now. After two years, I had returned to study. Unfortunately, I relapsed after the trial ended at the two and a half year point. Three out of the four people in my trial (who were not quite as sick as me, but pretty close to it) had a similar improvement. One girl, who had been bedridden since her teen years, moved out of home and started working, going out, living a normal life. Ampligen is not a perfect drug, but the results were miraculous for me. Right now I would give anything to go back on it again.

 

[Cort]

I would disagree with that. I was on a small trial in Australia where my doctor put the sickest of his patients on the Ampligen. I had been completely bedridden for four years, unable to tolerate sound or light and unable to digest food. Constant night sweats, fevers, whole digestive system covered in ulcers; every time I moved my heart would palpitate. My doctor was worried I was going to die. Six months on Ampligen and I started to improve. After about a year, I was going for walks outside, which is more than I can do now. After two years, I had returned to study. Unfortunately, I relapsed after the trial ended at the two and a half year point. Three out of the four people in my trial (who were not quite as sick as me, but pretty close to it) had a similar improvement. One girl, who had been bedridden since her teen years, moved out of home and started working, going out, living a normal life. Ampligen is not a perfect drug, but the results were miraculous for me. Right now I would give anything to go back on it again.

That's impressive Jeremy - what bad shape you were in! Thanks for sharing about your improvement. .

I imagine that as with any treatment that doctors will need to find the right combination of drugs or whatever to return people to health. Ampligen will clearly be an important treatment leg for some people.

I'm sorry you couldn't stay on the drug but hopefully Argentina is just the beginning and things will move more quickly. Ampligen is one positive trial away from being approved in the U.S.

Good luck with everything.

 

[Cort]

If you speak with Nancy McGrory again, please ask her why the have not kept in touch with those of us who were study participant's. I called them a few years after the study to see if I needed to update my address, and they were not interested in me. Thanks for your post.

Hopefully they will get their act together. It's a small company which hasn't until recently been managed particularly well - I think most everyone can agree on that...

 

[San Diego]

I would disagree with that. I was on a small trial in Australia where my doctor put the sickest of his patients on the Ampligen. I had been completely bedridden for four years, unable to tolerate sound or light and unable to digest food. Constant night sweats, fevers, whole digestive system covered in ulcers; every time I moved my heart would palpitate. My doctor was worried I was going to die. Six months on Ampligen and I started to improve. After about a year, I was going for walks outside, which is more than I can do now. After two years, I had returned to study. Unfortunately, I relapsed after the trial ended at the two and a half year point. Three out of the four people in my trial (who were not quite as sick as me, but pretty close to it) had a similar improvement. One girl, who had been bedridden since her teen years, moved out of home and started working, going out, living a normal life. Ampligen is not a perfect drug, but the results were miraculous for me. Right now I would give anything to go back on it again.

Keeping people like you away from a drug that gives you life borders on criminal if you ask me. I cannot imagine being taken off the one thing that wakes you from the dead like this. I’m sorry.

 

[SueS]

I remember reading a debut novel written by a CFS sufferer who was an Aussie. And though I can't remember what I did five minutes ago, I DO remember his name was Jeremy. Was that you, @Jeremy C.?

 

[Zapped]

The good thing about Capitalism is that it allows for the ongoing development of products. The
patent process is such that competitive, and in the end better products evolve in the marketplace.

Product betterment is usually done by varying one or more of the components of previous products to create a better mousetrap. It's the way of commerce and is justified legally, ethically and morally. Witness umpteen varieties of any consumer product, including drugs, each successive generation being better.

While the specifics of patent law is a specialized field, it is fundamental that ideas are not patentable.

In that regard, I could see the justification of getting 'our' hands on a vial of Ampligen, having it chemically analyzed, and creating a new analog by changing its constituency - perhaps adding a measure of another known immune modulator(s) and creating a new, more effective vaccine(?).

Lots of logistics to consider: grey market, black market or open competition, but we're talking about saving lives at the grass roots level while the official bureaucrats have their heads in the sand. Firstly, we need an advocate in Argentina (ME/CFSer?) who can obtain some of the existing product. Simultaneously, we would need a designated subgroup capable of implementing a plan. Of course, there's funding to consider - not out of reach for a determined subgroup of this forum leading a crowdfunding effort, ultimately with contributors getting proportional first access to the new product.

I, for one would happily donate to the cause. Any others interested in initiating such a trial - or alternative to concoct our own cure, before we're all invalids? It would not be for sale but 'home brew' for one's own consumption. As far as I understand there is no controlled substance to be concerned about.

 

[Mavis and Max]

Does anyone have up-to-date information on the biomarker that applies to Ampligen? @Cort

 

[Jeremy C.]

All I know is that Hemispherx doesn't appear to be using it yet. I am in the process of applying for Ampligen through the Special Access Scheme of the Therapeutic Goods Administration of Australia and have done the tests required by Hemispherx. While there were a lot of tests, none of them seemed to be anything out of the ordinary: just standard bloods, really.


I would also be interested in knowing what is going on in Argentina if anyone knows. Is it going to be cheaper there? Does anyone know of any ME/CFS doctors in Argentina?

 

[laureano]

All I know is that Hemispherx doesn't appear to be using it yet. I am in the process of applying for Ampligen through the Special Access Scheme of the Therapeutic Goods Administration of Australia and have done the tests required by Hemispherx. While there were a lot of tests, none of them seemed to be anything out of the ordinary: just standard bloods, really.


I would also be interested in knowing what is going on in Argentina if anyone knows. Is it going to be cheaper there? Does anyone know of any ME/CFS doctors in Argentina?

I'm from Argentina. Sadly, nothing seems to be going on here. I mailed the drugs administration department of our government and the company that is supposed to manufacture the drug in Argentina. I got no answer from any of them. However, that was months ago, when the drug was first approved. But you must bear in mind that this is an extremely underdeveloped country in many aspects, I think is possible that the drug is never sold here as any doctor here is aware of what ME is and they're clearly not willing to learn. They can't sell a product if they're no customers

 

[Jeremy C.]

Thanks for letting me know that, Laureano. I didn't know what the situation was with ME doctors in Argentina, but I was hoping it would be better than that. I also had problems contacting the company that is distributing Ampligen here in Australia, but learned that this is because they are not allowed to talk to patients, only to doctors. They were very happy to talk to my doctor. Perhaps it is the same in Argentina? But, of course, if no doctor is aware of ME and will help you, then that is of no use to you. What a pity.

 

[Mavis and Max]

@Zapped the chemical molecule is public: C28H40N9O25P3 It's the regulatory process that's a multi-million $ cost - that got nixed 8-5 by the FDA. Perhaps less, with the new 20th Century Cures act.

 

[shannah]

Letter to stockholders dated today:

http://ir.hemispherx.net/Events_Presentations

 

[SueS]

Dunno if there's anything in here of interest or not, but here are excerpts of the letter to shareholders dated 1 Feb 2017:

​

Initiatives for 2017 include: 1) generating the first sales of Ampligen® through our early access program in Europe and Turkey, 2) continuing discussions with the U.S. Food and Drug Administration (FDA) so that we can develop a path toward approval for Ampligen® in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), 3) continuing our efforts to secure out-licensing opportunities and/or senior co-development partnerships for our products, 4) monetizing underutilized assets, and 5) continuing to adhere to our plan of financial responsibility [edit: corporate capitalist piggery, trying to make as much off ill people as we can for our own benefit but refusing to call it greed - SS].​

​

... When I became CEO in March, 2016, I communicated to
you that my primary focus was “
to achieve long-term company growth through prudent execution of strong and effective business strategies
.” [edit: see above].​

​

... In May, we updated our agreement with Netherlands-based Impatients N.V. who conduct business as myTomorrows. MyTomorrows is currently managing an early access program (EAP) in Europe and Turkey to enable patients suffering from ME/CFS and pancreatic cancer to access Ampligen®. We have made steady progress on this front, with the first shipment of Ampligen® to myTomorrows having been completed in 2016 and additional vials of recently manufactured Ampligen® sent to myTomorrows in January, 2017. The EAP is an important step for Hemispherx as, not only are ME/CFS and pancreatic cancer patients obtaining the drug, but we will be recognizing our first significant corporate revenues from these sales. There are currently six (6) patients enrolled in the expanded Ampligen® EAP for pancreatic cancer and additional patients in the queue to enroll in the program for both ME/CFS and pancreatic cancer.​

​

In August of 2016, we announced a major breakthrough with the marketing approval of Ampligen® in the Argentine Republic for the treatment of severe cases of CFS. Our approval was the first in the world for this indication. Approval was based on the clinical data obtained from our two pivotal studies, AMP-502 and AMP-516. This marks a significant milestone for the Company, and we are working closely with our partner GP Pharm to complete the necessary activities before the commercial launch including manufacturing site inspections and reimbursement evaluation by the Health Services Authority. We expect these activities to be completed in early 2018.​

We anticipate that our need for product will increase in the coming years due to the European and Turkish EAP, future sales in the Argentine Republic and clinical trials in the U.S. To prepare for this demand, in July, we reached agreement with Avrio Biopharmaceuticals, now Avecia, to serve as an additional contract manufacturer to boost production of Ampligen®. The first shipment of this new product manufactured at Avecia was shipped to Europe in January, 2017 for sale utilizing the early access program and this product will also be available for our open-label, cost-recovery program in the U.S. Also, on January 3, 2017, Hemispherx entered into a purchase order with Jubilant HollisterStier, our primary contract manufacturer pursuant to which they will manufacture commercial batches of Ampligen® after performing tooling and validation activities required by the FDA.​

​

We successfully completed several corporate activities as well, which are important for the long term success of Hemispherx. In August, we raised $5 million in capital in a registered direct offering. The cash is being used to advance the important goals of the Company. We also regained compliance with NYSE MKT listing standards enabling the company to remain listed on that exchange. Finally, we settled all remaining material litigation against the Company. We expect 2017 to be another year of focused effective execution. First, we expect to continue our discussions with the FDA to identify a path forward for Ampligen® in ME/CFS. Although the results of these discussions are difficult to predict we are hopeful, based on the FDA’s interest in new therapeutic options for ME/CFS, that we can complete these discussions with a plan in hand. Second, we are also continuing to actively pursue potential partnerships to co-develop our clinical candidates. The same is true for our asset sale initiative, which we also outlined in 2016 and hope to update you in the near future on our progress. Third, as I noted above, Hemispherx is generating its first sales of Ampligen® in 2017.​

​

We have been working with our CMO partners to increase inventory of Ampligen® to supply the needs of the European and Turkish EAP. We also need to prepare for the Argentine launch of Ampligen® by the local distributor, GP Pharm, which includes both a manufacturing inspection and the building of product inventories prior to launch. Finally, we will need product to test in future clinical trials. 2016 was a very important and transformational year for Hemispherx, and we believe that we are well prepared to further advance the Company in 2017. We look forward to sharing our progress with you in the coming quarters.​

 

[Zapped]

@Zapped the chemical molecule is public: C28H40N9O25P3 It's the regulatory process that's a multi-million $ cost - that got nixed 8-5 by the FDA. Perhaps less, with the new 20th Century Cures act.

I suppose knowing the key molecule is helpful, albeit in context, but how does one come about #C28..P3? (No doubt, right next to #C28..P2).

Your bigger point is precisely the one I'm suggesting circumventing in a 'home brew.' Then it becomes a logistics problem... .

So, next step - how to access, formulate an equivalent elixir given such public
awareness? I recall development similarities with the polio vaccine and its analogs,
even convoluted Simiaan varieties which eventually got administered to the public; ...and further, coincidentally, may just play a role in our current ME/CFS conundrum!

Maybe 'home brew' here isn't really such a stretch... .