Ampligen: FDA Approval DENIED 12/1/2009

[consuegra]

ampligen sunk

The FDA sent a letter to Hemispherx saying that Ampligen is not approvable at this time and that an six month additional trial will be necessary. I would be surprised if this company can afford this trial. This is bad news.

Chris


http://cfspatientadvocate.blogspot.com

 

[perovyscus]

Article here:

http://money.cnn.com/news/newsfeeds/articles/globenewswire/179462.htm

The FDA's concerns seem legitimate to me. Hemispherx might need to muck their cards and license Ampligen to a capable entity for a rock-bottom price.

 

[dannybex]

While the drug helped some patients temporarily, they always relapsed afterwards. Plus there were also patients who testified it ruined their lives, made them much worse.

There are other drugs and natural remedies out there...different options for the many different causes and subsets, IMHO.

d.

 

[parvofighter]

AMPLIGEN - Another (6 month+) Clinical Trial Required

This just in - Ampligen is back to the drawing board - at least temporarily. The good part - it's a bit like "Whack-a-mole"... Hemispherx just keeps popping up again. Hopefully with WPI's involvement we'll get another scientific slam-dunk...

From CNN Money: http://money.cnn.com/news/newsfeeds/articles/globenewswire/179462.htm

PHILADELPHIA, Dec. 1, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company" or "Hemispherx"), announced that it received a Complete Response Letter from the U.S. Food and Drug Administration ("FDA") which describes specific additional recommendations related to the Ampligen(R) NDA. In accordance with its 2008 "Complete Response" procedure, the FDA reviewers determined that they cannot approve the application in its present form and provided specific recommendations to address the outstanding issues. Hemispherx is carefully reviewing the Complete Response letter and will seek an expedited meeting with the FDA to discuss its recommendations. Management is pleased to have received specific advice on the remaining issues and is looking forward to making a thorough but expedited response its top priority, and plans to take all appropriate steps to seek approval and commercialization of Ampligen(R).

"Most notably, the FDA stated that the two primary clinical studies submitted with the NDA did not provide credible evidence of efficacy of Ampligen(R) and recommends at least one additional clinical study which shows a convincing effect and confirms safety in the target population. The FDA indicated that the additional study should be of sufficient size and sufficient duration (6 months) and include appropriate monitoring to rule out the generation of autoimmune disease. In addition, patients in the study should be on more than one dose regimen, including at least 300 patients on dose regimens intended for marketing. Finally, the additional study must incorporate both a well-controlled QT interval study and pharmacokinetic evaluations. "

More at the site listed above.

 

[parvofighter]

?Opportunity to participate in Clinical Trial?

Just another note - this might actually expedite access for Ampligen in the short term for those patients that will be included in the clinical trial.

But it does delay full info on safety/efficacy - something participants should be aware of ... and of course delays FDA-approved access for the larger population.

 

[dannybex]

Chris posted a thread...

I hate to be Danny Downer, but I don't see how in the world the company will survive this latest disaster. They lied about study results in the last year, and also suggested in July it would probably get approved in a couple months, and because of those lies, they were sued by investors just weeks ago...so then they lied again in reply to those lawsuits...!!!

...so I have a feeling the Ampligen is toast.

A horribly mismanaged company, to say the least.

d.

p.s. just checked a website that shows after-hours trading. The stock has dropped almost 45% just today...now down to 69 cents...from a high of $4.52 six months ago.

 

[cold_taste_of_tears]

Wasn't Andrea Whittemore on this drug and it helped her significantly?
(I'm sure I read this a long time ago, and her mum mentioned it too maybe).

I doubt it's a case of people 'lying' about how good it is (Hemispherx) if Ampligen is synthetic RNA.

Synthetic RNA would help people with an RNase-L defect, that was one of the precursors to having Ampligen for patients with CFIDS.

I'm rather baffled to be honest.

 

[MEG]

The stock market is making a huge statement.

I had hoped for more from the company....I am disappointed as a lot of us must be.

 

[MEG]

Parvofighter

The clinical trials that I know of are "cost recovery" trials. It was too expensive for me. I wonder, reading your post, if they will have to actually fund some trials. Could be good for those who want to try Ampligen.
Danny Downer has a point though....
will the company even be running next week.
Interesting...

 

[Aftermath]

After this, we can only hope that Hemispherx goes out of business putting everyone from Carter down to the janitors out of work and that the patent on Ampligen is sold to the highest bidder.

This company flat-out sucks.

Also, just heads-up that I merged all of the Ampligen denial threads into this one here in the proper forum.

 

[fairlight]

Maybe someone will buy

Hemispherx?

 

[mezombie]

After this, we can only hope that Hemispherx goes out of business putting everyone from Carter down to the janitors out of work and that the patent on Ampligen is sold to the highest bidder.

Agreed. This twenty-year circus must end.

 

[Cort]

Check out Hemispherx's history here called Twisted History http://aboutmecfs.org/Trt/AmpHist.aspx

It's bad news for quite a few people. Andrea went off it because she had a bad reaction after decades on the drug. It was the only thing that helped her. After she went off she developed seizures - lots of them. She was at the dinner at the Reno conference but Dr. Mikovits told me her doctor was with her because she could have a seizure at any time. Apparently she was able to go back on the drug a couple of months ago.

There's Mary Schweitzer - she went off it a year or two ago - she's back in a wheelchair; she is nothing like she was before.

The company has just been terrible - lawsuits, weird accusations, etc. What a shame.

 

[dannybex]

Well...

Andrea went off it because she had a bad reaction after decades on the drug. It was the only thing that helped her.

...I hate to use the dreaded "H" word, but according to several articles, one of the first modalities that made a difference for her was homeopathy...

"Whittemore-Goad said she was about 11 or 12 when she first began getting headaches and suffering from extreme fatigue that no amount of sleep could relieve.

"I'd be in the classroom listening to the teacher, and I'd have to put my head down on the desk and rest awhile," she said. "I had flu-like symptoms, and my heart would race for no reason."

After years of being treated for the symptoms, she began seeing a local homeopathic doctor, and by age 17, she started feeling well enough to enroll at the University of Nevada, Reno.

But the university required she be current on her measles, mumps and rubella vaccinations.

"I got the vaccination, and I relapsed and never recovered."


I'm not sure, but I think she took Ampligen later, after that vaccination disaster -- (contaminated vaccines)?

From the WPI Facebook page: "Ampligen saved my life . So did homeopathic medicine, yoga, meditation, nutrition, and wonderful support from family and friends."

 

[cold_taste_of_tears]

Cold, Andrea Whittemore Goad was on Ampligen before and did well, and then was off of it. Recently, in the last couple of weeks, she went back on it.

Thanks, glad I'm not going senile. Well, partially.

Can we have some too then?

The person with the best jokes gets sent a months IV supply of Ampligen maybe?!

 

[dannybex]

It looks worse than I thought...

Okay, so this analyst has been trashing Hemispherx for months, but primarily because he seems to have been one of the few looking closely at the details of the ever-changing study 'results', and calling into question Dr. Carter's false proclamations.

Was about to hit the hay, when I saw his latest article, and it doesn't sound good at all:

"The FDA's complete response letter to Hemispherx -- summarized in the company's Tuesday night press release -- essentially instructs Hemispherx to start Ampligen's clinical trial program from scratch.

The agency's medical reviewers concluded that the two clinical studies of Ampligen submitted by Hemispherx "did not provide credible evidence of efficacy," according to the company.

In order to reconsider Ampligen for review, FDA instructed Hemispherx to conduct at least one additional clinical study in chronic fatigue syndrome. The study needs to test different doses of Ampligen for a minimum of six months, including at least 300 patients on Ampligen dose regimens intended for marketing, according to Hemispherx's summation of the FDA's letter.

Hemispherx could find meeting the FDA's demands exceedingly difficult and expensive. If the FDA requires 300 patients treated with Ampligen in a new pivotal study, for example, Hemispherx would probably have to enroll 450 total patients at a minimum (assuming two patients treated with Ampligen for every one patient treated with a placebo to act as a control.) By comparison, the Ampligen phase III study submitted and rejected by FDA enrolled just 230 patients total and took six years to complete.

But the FDA is asking for even more from Hemispherx, including tests of Ampligen in rodents to rule out the risk of cancer and a safety study in humans to ensure that Ampligen doesn't cause dangerous changes to a patient's heart rhythm.

Ampligen's manufacturing problems, previously flagged by FDA inspectors, also remain unresolved, the company said Tuesday."

http://www.thestreet.com/story/10636318/1/hemispherxs-ampligen-dealt-fda-blow.html

I don't see how this could possibly be turned around, unless of course stockholders (and maybe patients) demand Carter's resignation?

 

[acer2000]

I'm not suprised. As far as I have been able to find, there isn't really much *structured* recent data that shows safety or efficacy. There is annecdotal data that shows in some patients it helps substantially, even allowing them to go off of it and maintain improvement in some cases. However, despite looking, I have never been able to find information that explains how they figure out who is a good candidate and who isn't. I guess maybe Dr. Demeirler and Peterson probably have some idea from experience, but unless they can prove it in a clinical trial - they are hard pressed to approve it for "CFS" - especially with the wildly varrying responses.

Perhaps there is some more recent unpublished data that they can use to structure a new trial and recruit patients who more strictly fit the profile of those who respond favoribly. Of course, without a biomarker for CFS and lack of an effective definition even, it would be hard.

Is anyone a patient of Peterson or DeMeirler that can explain what markers signify to them that a person is a good candidate for Amp?

 

[starryeyes]

I read something (I think it was by KDM) saying why Ampligen makes some people better and others much worse.

Some PWCs have high protein kinase - usually the ones with very high levels of bacterial infection in the intestine and other places. They have worse gut symptoms than brain symptoms.

Others have low protein kinase (and a different profile of various other immune system markers) and these ones have worse cognitive symptoms and high viral titers.

The second group of people benefit from Ampligen because it raises protein kinase whereas the "bacterial" patients experience worsening of symptoms on it.

I cannot find the original article about this but I think it is interesting and I wonder if anyone else has read anything along these lines?

Hi Athene,

Thanks for posting this info. The other day I read that Mikovits I think it was said something similar but I hadn't heard about the gut vs. brain probs. Just my luck, I've got far worse gut probs than brain probs. My heart reacts badly to almost all meds too.

It's good to know more about Andrea Whittemore's reactions too. I didn't realize Ampligen could lead to seizures. I hope she does okay on it this time.

 

[Aftermath]

Hemispherx

Okay, so this analyst has been trashing Hemispherx for months, but primarily because he seems to have been one of the few looking closely at the details of the ever-changing study 'results', and calling into question Dr. Carter's false proclamations.

Was about to hit the hay, when I saw his latest article, and it doesn't sound good at all:

"The FDA's complete response letter to Hemispherx -- summarized in the company's Tuesday night press release -- essentially instructs Hemispherx to start Ampligen's clinical trial program from scratch.

I don't see how this could possibly be turned around, unless of course stockholders (and maybe patients) demand Carter's resignation?

Agreed. It's OVER for these people.

I can't see anyone being stupid enough to fund yet another Keystone Kops attempt at trying to get this drug approved.

I don't understand how this company it not yet out of business.

 

[dannybex]

Typical PR from Hemispherx...

http://philadelphia.bizjournals.com/philadelphia/stories/2009/11/30/daily23.html

"The Food and Drug Administration has rejected Hemispherx BioPharmas new drug application for Ampligen, an experimental treatment for chronic fatigue syndrome that the biotechnology company has spent more than three decades developing and testing.

Hemispherxs stock plunged more than 42 percent Wednesday morning to 68 cents a share from Tuesdays close of $1.20 per share.

Late Tuesday, the FDA told Philadelphia-based Hemispherx (AMEX:HEB) that two primary clinical studies submitted by the company did not provide credible evidence of efficacy of Ampligen. The agency is recommending Hemispherx conduct at least one additional clinical study, involving a minimum of 300 patients taking the drug for six months, which shows convincing effect and confirms safety in the target population.

In a statement, Hemispherx announced management is pleased to have received specific advice on the remaining issues and is looking forward to making a thorough but expedited response its top priority, and plans to take all appropriate steps to seek approval and commercialization of Ampligen.


What "remaining issues"? The drug was rejected because it was not shown to be effective, something they knew more than six months ago.

How stupid do they think investors are? I'm a brain-fogged, disabled PWC living on pennies a month, but even I'm not that dumb.

Sheesh.