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

[JohnnyD]

I disagree with pretty much everything Danny has posted. Adam Furestein is a pawn of criminals and is under investigation. See: http://www.exposeadam.com/ thestreet.ocm stock price has gone from $32 to $1.77 - it is a front for criminals.

6 BSL4 labs and Army researchers do not sepnd millions investigating your drugs unless there is something there. Army researchers co-presented the ebola research with hemispherx - unheard of - but I'd be happy to be proven wrong and shown another co-presentation with a public sector company. The EU granted orphan drug status to Hemispherx for the treatment of ebola. I really don't think the EU authority is part of the hemispherx scam.

Hemispherx is currently the ONLY biotech doing research, the ONLY biotech that has an interest in CFS. Talk about cutting off your nose to spite your face. Again, please show me another company.

The amp511 protocol was changed in November of last year. You need the FDAs blessing to change a protocol. The protocol design now has 3 arms - 100 healthy volunteers, 100 untreated CFS patients and 100 treated CFS patients. What's that about?

Because they keep studying ampligen CFS patients, this puts them in the running for further studies under the "21st Century Cures Act". There is a reason that 30 CFS ampligen patients flew across country, during the holidays, in a snow storm to testify in front of the FDA Advisory committee. From all walks of life, including doctors -- to beg the FDA to approve ampligen. It does not work for everyone, but most on the advisory committee admitted that there is something there.

They are collecting NK cell data trying to find the group that responds to ampligen. They recently singed agreements with health care orgs in the EU, Turkey, Australia, New Zealand - to provide ampligen on a wider, named patient basis and to keep collecting more data. You'll find it curious, and you can read it in the 10-Q, that hemispherx ordered 750K worth of ampligen making material from their suppliers. They've upgraded their plant - mostly for Alferon, but Ampligen as well, to the tune of 15mil. They are holding an open house at the plant in about 10 days, for investors.

In my opinion, they are putting in place the infrastructure to treat a large sub-group of patients (I cannot think of any other reason for all the activity), in these countries and including the U.S. The audit for the manufacturing cost of ampligen is also in preparation. They make no money on the drug, why would they audit cost now? Last audit was in 1998. I believe the amp511 will in the not too distant future, be obsolete.

Just to touch on a few points.

 

[dannybex]

@JohnnyD , what was Feurestein wrong about in his reporting re Hemispherx? The site you linked to leads to dead ends. Please be specific, not for me, but for the patients that are being led to believe that he is 'a pawn of criminals' and is 'under investigation'.

His work goes back to June 2009 when Hemispherx suggested to investors that Ampligen was close to being approved -- that they would be hearing from them soon, which sent the stock price soaring. Feurestein said they weren't telling the truth, and sure enough, when it was not approved several months later (November), the stock price tanked as you noted above. Who's fault was that?

Just recently, Hemispherx announced in a press release that “Anyone who reads the USAMRIID report can see Feuerstein is wrong. This is blatant short mongering at its worst,” said Thomas K. Equels, Hemispherx’ Executive Vice Chairman. “Feuerstein’s defamation of these results hurts not only the company’s stockholders; it impedes development of an important experimental therapeutic that could save thousands of lives in West Africa.”

http://www.hemispherx.net/content/investor/default.asp?goto=815

As noted in my earlier link, the USAMRIID denied this collaboration, stating: "There is no collaboration with them," Vander Linden said. "As you can imagine, we've been asked to test a lot of compounds against the ebola virus. This is not the first time someone makes a bigger deal out of something than it was."

Asked to respond to the USAMRIID statements, Hemispherx instead sent a pre-emptive cease-and-desist letter accusing TheStreet of libel and threatening "civil remedies" and a "criminal investigation" if this story was published."

They obviously published the story, and no lawsuit was filed. Instead Hemispherx settled the suit that was filed against them by shareholders. Why did they pay out $2.75 million dollars if they were not guilty?

And if they care so much about ME/CFS patients, why didn't Hemispherx announce patient recruitment for this new version of the 511 study last November? They're certainly experts at putting out press releases, so why did they miss that one?

And lastly, why do they keep pushing the drug for a dozen other diseases instead of concentrating on ME/CFS patients, which seem to be the only group that the drug has actually worked for?

 

[JohnnyD]

@JohnnyO, what was Feurestein wrong about in his reporting re Hemispherx? The site you linked to leads to dead ends. Please be specific, not for me, but for the patients that are being led to believe that he is 'a pawn of criminals' and is 'under investigation'.

Danny, I'll make a few points - but will not get into the history of the criminal hedge fund(s) or short sellers that have been manipulating hemispherx stock since 1998. Biotech's are vulnerable as they have long development times. Hemispherx undertook treating CFS patients with ampligen, at the FDAs request, at a time when no other federal agency (including the FDA) believed that CFS was a real disease. You know the history. Good luck with that, uh?

His work goes back to June 2009 when Hemispherx suggested to investors that Ampligen was close to being approved -- that they would be hearing from them soon, which sent the stock price soaring. Feurestein said they weren't telling the truth, and sure enough, when it was not approved several months later (November), the stock price tanked as you noted above. Who's fault was that?

Feurestein also said that Hemispherx would withdraw their NDA. Pretty strong assertion. It was a lie and didn't happen. There are plenty of examples of Fuerestien manipulating biotech stocks other than hemispherx - you just have to google "adam feuerstein manipulation" or other key phrases. There are no dead ends, just more of the same.

in my earlier link, the USAMRIID denied this collaboration, stating: "There is no collaboration with them," Vander Linden said. "As you can imagine, we've been asked to test a lot of compounds against the ebola virus. This is not the first time someone makes a bigger deal out of something than it was."

I emailed Vander Linden, who requested that I call her. She is an administrative assistant. (I'll be happy to PM you the emails). Here is what she said on the phone... and this is also posted on the yahoo message board with a date of February 4, 2015. You can search for it.
-----
Per my conversation with Ms Vander Linden this morning:

"I'm not very happy about The Streets Story. They took what I said out of context. I made a rookie mistake."

Swell guys Adam and the street. Dollars to donuts they recorded her without permission. And with leading questions. It doesn't get any stinkier than Adam and the street. I hope HEB files suit.
------

Why did they pay out $2.75 million dollars if they were not guilty?

The insurance company that covers hemispherx decides. It is often cheaper to settle than to litigate - nothing to do with guilt -- again, it's the insurance company that decides (ask around) as they are the ones paying the cost. Biotech is a risky business and the vultures know this. Google this: "Pomerantz LLP adam feuerstein" -- kind of funny how often this law firm is associated with adam, no?

if they care so much about ME/CFS patients, why didn't Hemispherx announce patient recruitment for this new version of the 511 study last November? They're certainly experts at putting out press releases, so why did they miss that one?

Hemispherx has 4 or 5 active trial sites, with plenty of patients - it is the doctors at these sites that enroll and test patients. Why would they need a PR? There are lots of CFS patients, however not many that can afford to relocate and then also pay for the drug.

lastly, why do they keep pushing the drug for a dozen other diseases instead of concentrating on ME/CFS patients, which seem to be the only group that the drug has actually worked for?

Concentrate on a disease that until very recently no government agency believed was real? Put all your eggs in that basket? You must be kidding. You are lucky to have one company trying to develop a new drug for CFS. The FDA's Workshop on Drug Development for CFS in April of 2013 had no takers. Hemispherx is your company for new drug development, like it or not.

Both Ampligen and Alferon are broad spectrum anti-virals, with unique properties. They are immunological drugs that can stimulate the bodies natural defenses, and that work against a variety of pathogens. There is no question that they work against a variety of pathogens because government researchers have tested the drugs, on their nickel. The NCI is currently collaborating on three related cancer trials. In other words, hemispherx is not paying for this research or these trials. Hemispherx's part is... providing the drug. Both drugs have a lot of promise and the science proves it.

And ultimately, Hemispherx is a public company, who must answer to its shareholders.

 

[dannybex]

I think you give Feurestein waaaay too much power and let Hemispherx's management off the hook. If he's done them so much damage, where's the lawsuit they've been threatening him with for so many years?

If Ms. Vander Linden's comments were taken out of context, that's a shame, but if so, then shouldn't we be seeing more news about Ampligen and Ebola? Couldn't the USAMRIID issue a new press release clarifying her statement?

You do make a good point about putting all their eggs in one basket. It just seems like they keep continually adding to that basket, instead of concentrating or building on the partial successes they've had so far.

Regarding the ongoing study: Why would they need a press release? Why not? I would think they would put one out to tell investors (and patients) that they are indeed following up with the FDA's request for a new study.

And again, I'm not questioning whether the drug is effective for some patients. I'm questioning the management's troubling history, their decisions, and their questionable statements over the last 10 years.

Just last year Hemispherx lost $8,792,000 -- about half their asset value. So I have to wonder, when they're doing that poorly, why CEO Carter was paid $2,364,875 and the CFO got another $1,668,449?

http://www1.salary.com/HEMISPHERX-BIOPHARMA-INC-Executive-Salaries.html

You're right -- Hemispherx is a public company, who must answer to its shareholders. Which I guess is why they were sued and settled. Hopefully they'll make some big changes soon, starting with salaries.

Again, I know we'll have to agree to disagree.

 

[jamesripp]

Great points made by the last two commenters. I will just add what I have found in my research (I'm a Hemispherx shareholder):

Those who are privvy to this subject have suggested that big pharma interests kept the FDA from approving Ampligen in the first place.

Here's the salient quote:

"There is blame to go around for many; Dr. Carter not selling out to Big Pharma is the political reason why it will never be approved. I learned some things others do not know while receiving my infusions. If Big Pharma had the patent the FDA would have fast tracked Ampligen without hesitation. The FDA will never grant Hemispherix approval because only Big Pharma is allowed to make the big bucks. Dr Unger [the lead scientist of the CDC department that oversees chronic fatigue syndrome] was instructed to say no and was just following orders so you can’t blame her for it."​

Emphasis supplied.

Without getting into any specific conspiracy theory, Hemispherx may have faced some very powerful opponents in getting Ampligen approved on the first try. If Hemispherx had been forced into bankruptcy, a big pharmaceutical company could have bought the patent to Ampligen dirt cheap and exploited it for huge profit. Something similar happened recently to a company that, surprisingly enough, had also been attacked by Adam Feuerstein.

 

[Anne]

So, putting history aside, where are we at now? Is this the end for Ampligen for ME/CFS, since patients will be dropping out of the cost recovery open label study due to the hugely increased costs?

Also: is there no mechanism by which the FDA or the NIH can take charge when what seems to have happened here happens: there exists a promising drug for a patient group which a great unmet need, but the drug company is (for one reason or another) unable to produce large enough studies to get it approved? Of course there would need to be a structure for reimbursing the company as patent rights are taken over, but the studies on the drug can then move forward.

I'm thinking a promising drug shouldn't be allowed to disappear altoghether because of company issues.

Does such a mechanism exist?

 

[jamesripp]

Good question Anne. I believe Hemispherx is trying to find such a mechanism. Here's a quote from their latest quarterly report:

"FDA regulations provide a formal dispute resolution process to obtain review of any FDA decision, including a decision not to approve an NDA [New Drug Application], by raising the matter with the supervisor of the FDA office that made the decision. The formal dispute resolution process exists to encourage open, prompt discussion of scientific (including medical) disputes and procedural (including administrative) disputes that arise during the drug development, new drug review, and post-marketing oversight processes of the FDA. Depending on the outcome of a number of initiatives in the CFS community, including the FDA's Patient Focused Drug Development Initiatives, forthcoming drug guidance and other scientific initiatives by the Institute of Medicine, Center for Disease Control and National Institute of Health, we will continue to examine the opportunity for an "end-of-review" meeting. Depending on the results of these initiatives, we may request an "end-of-review" conference with the FDA as a precursor to a possible submission of a formal appeal to the Office of New Drugs within the FDA's Center for Drug Evaluation and Research regarding the FDA's decision."
​

In other words, they are hoping to appeal the rejection of Ampligen. I believe management might have been postponing the new study to pursue this appeal (which will be much less costly and time-consuming).

 

[Riley]

Those who are privvy to this subject have suggested that big pharma interests kept the FDA from approving Ampligen in the first place.

Holy shit!! I know him!! He was finishing up when I was starting in 2011 i believe. He made a remarkable recovery and then stopped due to financial reasons.

We at the clinic never heard from him again despite reaching out and still wonder what happened to him. That's really terrible that he relapsed.

As for inside information, I was in the room with him, and there really isn't any. We definitely weren't told about some big pharma conspiracy.

What I don't understand is that Beth Unger has said that she thinks ampligen should be available, yet she voted no on the approval committee. I heard her explanation was that she felt she could not vote yes based on the data presented.

However, others on the committee did vote yes.

I don't know if everyone realizes (though it is public record) how close ampligen was to approval. It was approved for safety and only failed the efficacy vote by two votes! To rub salt in the wound two of the no votes were Dr. Unger and Dr. Komaroff! If they had voted yes, ampligen would be approved now.

That is really tough to swallow for me, so I try not to even think about it.

 

[Ecoclimber]

@jamesripp I don't hold to conspiracy theories with regard to Hemispherx Biopharma. I wasn't going to get into this even though I have been tagged somewhere in this thread. They have a long history which I will not go into. They could have been approved if they followed the proper procedures. There has always been a serious issue with the executive leadership of this company.

From a financial stanpoint, there have been many pump and dump activities with this stock to the point that it has been driven down to a penny stock status. On the Yahoo financial boards, there have been a particualar individual virgorously promoting this stock at the consternation of other investors over the years. There is an issue as you can buy thousands of shares at low cost and if this drug gets approved for drug treatment or acquired by another company, will make millionaires out of lot of current investors including the current owners. You also have the fact that there have been numerous class action lawsuits over the years from investors for security fraud violations which affects the reputation of this company...far more than the average corporation.

From a medical standpoint, you have the outrageous Hemispherx claims concerning this drug. It has been labeled by one financial expert as drug searching for a disease. To make the claims by the leadership of Hemispherix that this drug can treat a host of diseases too numerous to mention here, destroys the credibilty of this company. Each disease is biologically differenct on how it impacts the immune system, so to claim that a drug could be effective for treating
ovarian cancer, influnenza, mers, sars, ebola, hpv, west nile both viruses, retroviruses, bacteria, cancer etc bascially destroys the credibility of this company and makes you wonder if such claims are used to take advantage of manipulating the stock prices to make financial gain than any efficacious effect on disease eradication.

I know there are patients on here who have stated they have been helped by this drug. Is it a placebo effect? I don't know. Some of these patients, I do not doubt that it has a positive effect since I know the reputation of these patients. I do have problems with patients signing on PR for the first time and then make their first posts stating how effective Ampligen has helped them @denmarkk without any verification on the vailidity of such a statement. I cannot believe that over the years that Ampligen has been around, that management could not find the resources either through venture capital or in partnership with another pharmaceutical to conduct the trials needed to bring this product to market.

I do have a problem with raising the costs of this drug. Perhaps to raise sufficient capital to conduct trials? But then, you are raising capital through the desperate needs of patients. But if there is a cash flow issue, why has the board of directors consistently voted for six figure increases in executive compensation and bonuses going back as far as 2007? I'm not going to trace any further. Each patient should conduct due diligence on this company before making any decision on treatment. I will not respond futher to any posts or tags referencing my comment.

 

[denmarkk]

@Ecoclimber I have issues with the company, too. But I'm a real live person who thanks to Ampligen is now making health gains. I've been open online on many sites about Ampligen, before and now, while being the program. I even have a real picture of myself. Why the attack on my credibility just because you personally don't know me? After 5 months of treatment, my doctor and I are positive it's not a placebo effect. What do you want, a copy of my labs showing my improved liver function and deceased viral titers?

When I was trying to decide to enter the Ampligen511 program, I was hungry to meet others online to learn more of their experience, whether it was good, bad or ugly. Now that I'm in the program, I'm trying to be visible to others who may be trying to make the similarly difficult decision. I would, also, like to be in contact with others who have longer experience using the drug. That's my only reason for posting here. I'm not a company plant.

 

[dannybex]

It gets even worse. According to Ampligen patient 'Matt', commenting on Jeannette Burmeister's blog, Hermispherx is not only raising the price astronomically, but they may be telling patients that they "will not be able to miss more than four consecutive infusions under the new protocol which means no more drug holidays."

That's just bizarre to me, and suggests again, that they're more interested in the bottom line, than the interests and welfare of patients.

Here's the link to the thread Jeannette started, with links to her blog:

http://forums.phoenixrising.me/inde...e-increase-on-shaky-ground.39297/#post-630115

 

[denmarkk]

@dannybex That part confused me, too. Just two months ago a HEM rep visited the NY clinic and was telling me about how after a year or so, people could go off for 2 months and then go back on for 2 weeks into order to stretch out the maintenance doses and people were getting good results with that schedule. I wonder if we will still be able to do that?

 

[heapsreal]

I think they need to find an easier way to administer it. Maybe subcut infusion similar to what people are doing with ivig.

Surely this would increase sales and keep prices down and reduce cost to patients as they wont require hospitalization for infusions.

I guess it needs approval first though.

would think that once one got to a certain level of improvement with ampligen , that they could work out some type of maintenance therapy eg 3 months of infusions every 9 to 12 months or something like that. Not only keeps affordability for patients but may help with possible tolerance.

 

[dannybex]

@dannybex That part confused me, too. Just two months ago a HEM rep visited the NY clinic and was telling me about how after a year or so, people could go off for 2 months and then go back on for 2 weeks into order to stretch out the maintenance doses and people were getting good results with that schedule. I wonder if we will still be able to do that?

Well, according to Matt, it seems like the answer is no. Probably would be better to ask the question on Jeannette's blog, or on her thread.

 

[acer2000]

I cannot believe that over the years that Ampligen has been around, that management could not find the resources either through venture capital or in partnership with another pharmaceutical to conduct the trials needed to bring this product to market.

I really wonder about this also.

 

[niall]

This I true. I am a current patient. The price is changeing from $75 to $200 per 200ml bottle. The "standard" dose is 400ml twice per week. So the price is almost tripling! It's going from $1200 per month to $3200 per month plus $1000 per month infusion cost.

They are also making some changes to the protocol. The main one affecting patients being that drug holidays (breaks from the drug while remaining enrolled in the study) are no longer allowed.

Under the new rules, if a patient misses more than four consecutive infusions, they are kicked out of the study.

This is a major hardship for those of us who have been on ampligen long term as drug holidays allowed us to take breaks and save money, but I guess that is moot since none of us can afford it at all now.

None of the doctors or patients were given any advance warning about this, and the changes are to go in effect immediately.

I know that my doctor was furious when he found out. I myself am devastated, as ampligen is my lifeline.

I will try to detail my experience with ampligen in another post if I can and people are interested.

I will say that this drug WORKS! It is safe, and it works for most patients. From what I have seen, most patients slowly and steadily improve on ampligen.

I don't have much time to write more this morning. I was at Nova clinic last week and the nurse practioner told me that Hemisperx was raising the price of Ampligen, so that is true. However, they are supposed to cover the cost of the IV's.
Dr. Klimas told me that Dr. Peterson is using 200mg per week as a therapeutic dose for many years with good results and less side effects. Dr. Klima intends to start Ampligen soon. So 100mg will be $200 and be administered twice a week at a monthly cost of $1,600 a month. I will be going to the clinic on Tuesday. If I learn any new information I will post again.

 

[Charles555nc]

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.

Hey Daffodil, any updates, new treatments I need to know about? Btw I found selenium 200mg 5 days a week helped my activity levels and phosphatydl choline repaired the never ending blisters on my feet.

Im also reading alot on magnets and infections.

 

[Daffodil]

Hey Daffodil, any updates, new treatments I need to know about? Btw I found selenium 200mg 5 days a week helped my activity levels and phosphatydl choline repaired the never ending blisters on my feet.

Im also reading alot on magnets and infections.

hi Charles nothing new that I am aware of....but I dont really read about this like i used to years ago. I am still on a tetracycline (Tetralysal) and chlarythormycin and not feeling very well at all. Hoping it is part of a herx. Stiil feel that I am on the right track, however I am glad you are having some luck with supplements...none seem to do anything noticeable for me!
xoxoxo

 

[Charles555nc]

hi Charles nothing new that I am aware of....but I dont really read about this like i used to years ago. I am still on a tetracycline (Tetralysal) and chlarythormycin and not feeling very well at all. Hoping it is part of a herx. Stiil feel that I am on the right track, however I am glad you are having some luck with supplements...none seem to do anything noticeable for me!
xoxoxo

supplements help me but not you, and herbs do nothing for me and some for you....