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

[taniaaust1]

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.

Let's hope it doesn't end up being like a repeat.

 

[heapsreal]

It's no different to rituximab in that they dont know who is a responders or not.

Biomarkers are needed for these drugs to follow while on treatment so the right patient for the right drug happens.

ampligen studies need to be done properly and helped by govt funding as it will reduce costs of long term issues with cfs.

We need markers for all drugs to show if one will be a responder or not.

 

[ukxmrv]

It's interesting that "mytomorrows" has the Norway rituximab trial included on their website

https://mytomorrows.com/program/b-l...halopathy-cfsme-a-randomized-phase-iii-study/

I'm wondering if they will be involved in any "early access program" for this drug or anything else the team in Norway comes up with? I'm guessing that they just picked up this trial from a list of European drug trials but could be wrong.

I can't see any great advantages to this arrangement unless some doctors in Europe decide that they want to offer Ampligin or Rituximab to their patients and want to use Mytomorrows to "facilitate" this.

For Ampligin it's been the lack of European doctors who wanted to use it and were not scared of their local GMC that has been the problem. I did hear that part of the problem was dealing with Hemispherx so we'll see.

 

[jimells]

"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)..,

This is an excellent illustration of the harm done by junky CDC studies that erroneously conclude

http://www.ncbi.nlm.nih.gov/pubmed/25647777

these conditions contribute to the development and/or perpetuation of CFS in some women

(maybe slightly out of context)

 

[Daffodil]

didnt nancy keiser eventually end up with breast cancer and denounce ampligen?

 

[Daffodil]

it's weird....my infectious disease doc told me up front when i went to see him about CFS: "dont ever ask me for ampligen because i will never give it to you."

 

[Riley]

There was just an MEAction post stating that they are also more than doubling the price in the US. Can anyone confirm?

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.

 

[dannybex]

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

But apparently that's not the entire story:

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

Anyway, I do agree w/you that many patients have been brought back to life due to Ampligen.

 

[Daffodil]

@Riley is it really fair to say it helps "most"? i thought it was less than 50%...a lot less?

my friend feels like it poisoned him

 

[Jonathan Edwards]

This looks pretty dubious to me. MyTomorrows seems to be an advertising agency that takes money from companies that want to sell drugs outside proper licenses and then advertises its wares to physicians. I personally would not want to recommend getting involved in physicians who work through this route. If a physician is knowledgeable enough to know what drugs in development would be worth accessing for their patients then they should approach the company directly or use the drug off label if it is already in the pharmacy (as for rituximab). There is no reason why a paid agency should be involved.

As far as ampligen goes I cannot see why specialist ME physicians thinking of studying its effects should not work directly with Hemispherx. I rather suspect that MyTomorrows is a sort of start up on venture capital that will fold fairly soon but is going around doing deals with companies to try to get a foothold as an unnecessary middle man. I doubt it will have any impact on availability of drugs to patients with ME. It shouldn't if the physicians know what they are doing.

 

[Riley]

@Riley is it really fair to say it helps "most"? i thought it was less than 50%...a lot less?

my friend feels like it poisoned him

From what I have seen, yes that is fair to say. When I say most, I mean greater than %50.

Your friends experience does not surprise me. Generally patients have exacerbated symptoms in the first six months, and gradual improvement follows after that. There is also a flu like feeling that sometimes follows infusions.

I have seen patients come and do about a few months and then quit because they feel bad, but most of the time the ones that stick it out begin to gradually improve around the six month mark.

 

[Daffodil]

@Riley I think my friend took it longer than 6 months..maybe a year or so. But if it works for you, that is great.

 

[JPV]

@Riley is it really fair to say it helps "most"? i thought it was less than 50%...a lot less?

my friend feels like it poisoned him

From an article posted earlier in the thread by @dannybex. It's from a participant in the phase III trial that apparently went on for 10 years...

From our group of 25, there may have been 3 people that were helped, about 25% had no noticeable change, which is probably normal in a double blind test. 25% had a slight relapse and 25% had a very severe relapse. If only one eighth of our group seemed to be helped, does this justify putting a drug on the market? Incidentally, those of us that had a severe relapse, felt that our health got worse after getting off of the drug Ampligen. We are still in touch with those who were on this trial.

 

[acer2000]

HEB is a weird company. There has to be no more than a couple dozen patients actively taking Ampligen in the USA? Maybe a few more abroad? Either way access is severely limited due to the costs and the fact that there are only a couple of doctors doing the "cost recovery" study.

HEB has been cruising along like this for years with basically no revenue and their stock in the toilet. Wouldn't you think that if their goal was to see approval for Ampligen or make them selves attractive as an acquisition target they'd want to *lower* the barriers to enroll patients to get the numbers up and collect more evidence about the efficacy? The FDA basically told them they would approve the drug a couple years ago if they followed through on their demands for a further study, yet they didn't do this?

HEB market cap is only 45M. Is Ampligen even patented anymore? Does HEB have a board or any corporate governance at all? They are a public company.

 

[acer2000]

Well it looks like I answered my own question (partly):

http://www.bizjournals.com/philadel...-biotech-hemispherx-biopharma-settlement.html

What if they had instead spent that 2.75M on actually doing the research needed to show that Ampligen works?

 

[denmarkk]

I've been on it for 5 months and it has helped me so much. Still housebound, but I don't have all those horrible flu-like symptoms. My cognitive function, balance, heart palpitations, pain and stamina are all slowly improving. Before the drug, I couldn't read but a couple paragraphs. Now I'm back to reading books. My last blood work showed my liver function is improving. I'm a lucky one, because not everyone responds, and of those who do, not everyone responds so well.

 

[dannybex]

Well it looks like I answered my own question (partly):

http://www.bizjournals.com/philadel...-biotech-hemispherx-biopharma-settlement.html

What if they had instead spent that 2.75M on actually doing the research needed to show that Ampligen works?

People have been asking that very question for more than a decade.

 

[Anne]

Are there ongoing studies in the US?

If so, are the patients in these studies paying out of pocket? - in which case I suppose now such studies would be in danger.

(Is the cost recovery program mentioned by Jen Brea a study?
http://www.meaction.net/2015/08/10/ampligen-price-increases-substantially-available-soon-in-europe/ )

@Ecoclimber @alex3619 @ukxmrv @dannybex

 

[Riley]

Are there ongoing studies in the US?

If so, are the patients in these studies paying out of pocket? - in which case I suppose now such studies would be in danger.

(Is the cost recovery program mentioned by Jen Brea a study?
http://www.meaction.net/2015/08/10/ampligen-price-increases-substantially-available-soon-in-europe/ )

@Ecoclimber @alex3619 @ukxmrv @dannybex

The only study going is the Amp 511. This is a "cost recovery" trial in which the patients pay for the cost of the drug. This has been the only trial that I know of for many years.

It does seem like a paradox. Hemispherix needs data to get FDA approval, but raising the price will all but eliminate trial participation.

My understanding is that Hemispherix just does not have the money to conduct more studies. I think the only hope now for them and us is to pressure the FDA to make ampligen available based on its track record of 25 years and dire need of this patient population.

I was told that Hemispherex had to either raise the price of Ampligen or end the Amp 511 program which would make ampligen completely unavailable.

 

[dannybex]

The only study going is the Amp 511. This is a "cost recovery" trial in which the patients pay for the cost of the drug. This has been the only trial that I know of for many years.

As in TEN years. It started in 2005:

https://www.clinicaltrials.gov/ct2/show/NCT00215813

…and it certainly wouldn't be considered a sufficent 'study' by the FDA. And Hemispherx knows that. They've known it since the last 'study' was rejected six years ago.

It does seem like a paradox. Hemispherix needs data to get FDA approval, but raising the price will all but eliminate trial participation.

My understanding is that Hemispherix just does not have the money to conduct more studies. I think the only hope now for them and us is to pressure the FDA to make ampligen available based on its track record of 25 years and dire need of this patient population.

They don't have the money for the studies, because they've been pocketing it at every opportunity, see link below.

Ampligen obviously works for a subset of the patient population, even if it is a minority. But if people will take their blinders off, I think the reality is that unfortunately Hemispherx clearly has no interest in seeing the drug approved for ME/CFS.

I know I seem like the resident crank when it comes to Ampligen. I'm not. Hemispherx, the company that makes it, is another matter. There are many, many others who feel the same way -- they're just sick of talking about it, and frankly so am I.

But if one looks at the company without wishful thinking, they'll see that Hemispherx has a 30 year history of questionable practices. The reason they had to pay $2.75 million in the lawsuit mentioned above by @acer2000 is because they were guilty.

There are dozens of articles that have talked about their Hemispherx's shady dealings. Here's one that fits their typical pattern, this time pushing Ampligen as a treatment for Ebola, but in reality, using the Ebola scare to raise the price of the stock so they could cash in:

http://www.thestreet.com/story/1307...gedy-to-raise-cash-pay-executive-bonuses.html

"The Hemispherx press releases touted its experimental drug Ampligen as a possible Ebola therapy. The company failed to mention that it has promoted Ampligen as a treatment or cure for pandemic diseases for the past 30 years without success. Twice in the past five years, Hemispherx sought to gain U.S. approval for Ampligen. The FDA rejected both applications, citing insufficient clinical data collected from poorly conducted clinical trials.

Some of the recent press releases issued by Hemispherx claimed that U.S. Army medical researchers were working with the company to develop Ampligen as an Ebola treatment. The truth was far less impressive: Hemispherx merely paid the U.S. Army Medical Research Institute of Infectious Diseases to conduct animal studies.USAMRIID later rebuked Hemispherx, stating publicly that there was no collaboration with the company to develop Ampligen against the Ebola virus."

30 years, and it hasn't been approved for any illness.