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Adrienne Dellwo

New Data on Ampligen's Immune Impact

By , About.com Guide   February 3, 2010

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NEWSBRIEF: The immune-modulating drug that's so far failed to gain FDA approval as a chronic fatigue syndrome treatment now has some data backing its use in cancer immunotherapy.

Stanford University researchers say Ampligen (rintatolimod) "shows promise" at making some cancer immunotherapies more effective. They also say that Ampligen enhanced T-cell stimulation and caused the release of proinflammatory chemokines an cytokines. They also say it had these effects without the toxicity of drugs currently in use. The peer-reviewed article was published in the American Journal of Obstetrics and Gynecology.

Ampligen's manufacturer, Hemispherx Biopharma Inc., tried last year to get the drug FDA approved for chronic fatigue syndrome. In December, the application was denied, but in its Complete Response Letter the FDA made recommendations to the company about what would be needed for possible approval. Hemispherx has said it will try to fulfill those recommendations and try for approval once again. Ampligen currently isn't approved for any use.

Ampligen also is being studied in Japan as a flu-vaccine enhancer.

In Related News: The FDA has reevaluated and approved a subcontractor working with Hemispherx to manufacture Ampligen. Problems with the subcontractor's facility were noted in the Complete Response Letter mentioned above. This is at least the second goal Hemispherx has met in regards to the Letter, but it still would also need more clinical trial data to reapply for FDA approval.

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Comments
February 3, 2010 at 9:24 am
(1) George says:

Oh my, you are still suggesting Ampligen could treat CFS? I thought the Ampligen scam was put to rest a month ago.

I guess there is a reason HEB stock still trades at a price even though the company has nothing of value. Some people still believe the press releases put out by Hemispherx.

Amazing.

February 4, 2010 at 8:46 am
(2) Dave says:

George, you are obviously a stock trader posting garbage here for your own gain. You should be ashamed of yourself. There are real people suffering from this disease!

February 5, 2010 at 9:49 am
(3) George says:

I am not the one that should be ashamed…Dr. Carter should be ashamed for running a scam at our expense for over 20 years. I once looked forward to trying Ampligen in the mid-1990’s…at some point, you have to call a spade a spade.

February 5, 2010 at 3:34 pm
(4) RM says:

Adrienne,

Are you sure this study was done at Stanford? The article link provided goes Pubmed which lists the contact address of the researchers in Medford, MA. Thanks for following up on Ampligen.

February 5, 2010 at 4:03 pm
(5) Adrienne Dellwo says:

RM,

I don’t know if it was actually done at Stanford or at the facility listed in PubMed, but Stanford researchers were involved. Here’s more: Stanford University Publishes New Data on Ampligen.

February 5, 2010 at 4:07 pm
(6) Adrienne Dellwo says:

Ah, George! I can always count on your comments when Ampligen comes up, LOL. Please understand that it’s not my opinion in this post — I’m just reporting on the research.

I do think you need to accept that Hemispherx will continue to push for Ampligen’s approval, and that some people with ME/CFS say they are helped by it. Maybe someday you’ll be proven right, and maybe not, but in the meantime there’s certain to be a lot more coming out about Ampligen.

And Dave — George is for real, not just a professional Ampligen basher. Play nice, gentlemen!

February 5, 2010 at 5:28 pm
(7) Kelvin Lord says:

I understand how people might be dismayed if not outright disappointed with Hemispherx and their spotty history with both the drug approval process, and communications of same. But those problems don’t change the fact that in my view, Ampligen has historically shown to work in a majority of M.E. patients, is an effective immune-modulator, and is now actually working in me. I also find many airlines to be badly run today, poor communicators, and not customer-centric, but it doesn’t mean I stop flying. If you want a patient’s view of Ampligen, what it does, how it feels, without the hype and hypocrisy, I invite you to follow my blog where I post after every treatment, twice a week: http://ampligen-treatment.blogspot.com.

February 5, 2010 at 9:47 pm
(8) Tammie says:

There is one big problem with the possibility of using Ampligen off label if it gets approved for cancer, and that is the cost. If it’s off label, insurance companies are not going to cover it for CFS, and the last I read, it was around 20,000 a yr.

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