Chronic Fatigue Syndrome Blog

Ampligen is a drug that may, if sanctioned by the FDA, end up being the first drug approved for the treatment of chronic fatigue syndrome. Ampligen was created in 1970 by Hemispherx Biopharma and since then has had a long a difficult struggle to receive approval and prove that it is a legitimate treatment for CFS. There have been subjects of clinical trials that believe Ampligen cured or made them significantly better. (Mary Schweitzer) But, there have also been detractors of Ampligen (Manuel Asensio),that have even been brought to court over alleged demafatory statements made about Ampligen’s lack of effectiveness.
When ampligen was first created in 1970 it was found to slow down the growth of tumors and increase the release of interferons. It may have been intended at the time for the treatment of cancers and later HIV. But, clinical trials for Ampligen’s treatment of CFS were started in 1988. The drug was made available in Canada and Belgium under emergency drug release programs for Chronic Fatigue Syndrome and HIV in 1996.

How the drug works is not fully inderstood. Scientists believe that its effects lie in how it affects to enzymes 2-5 Synthetase/RNaseL pathway. There are doctors like Paul Cheney that believe that the RNase L activity is triggered by a viral infection, and increased RNase L activity could be a possible trigger for onset of CFS. The upregulation of these pathways may lead to decreased ability for the body to destroy viruses and viral RNA.

In April of 2007, Hemispherx came out with a statement saying that they believed they now understood the mechanism of action. They believe it to be through receptors in the body called TLR - 3’s. These naturally occuring receptors in the body, are used to detect pathogens and may increase the body’s response to infectious agents. Ampligen may work and these receptors to increase a patients stifled immune response.
The last phase of the clinical trials for ampligen were completed in 2004. After 3 long years of missed deadlines, the NDA or “New Drug Application” was filed on October 11 2007. Many Chronic Fatigue Syndrome patients are hopeful, but still unsure if the drug will be approved or if it will be effective.

Here are the steps the FDA will take after Ampligen’s NDA has been submitted:

1. The Drug Manufacturer Submits of a New Drug Application, this is the first step that asks the FDA to consider approval.
2. The FDA will take up to 60 days to whether to file and send the application to be revewed.
3. If they decide to file the NDA, a group from the FDA is formed to review the drugs effectiveness and possible safety concerns.
4. The group reviews the drugs informational labeling and decides if it is adequate.
5. The FDA review group tours and inspects where the new drug is manufactured and bottled.
6. The group submits the review as approvable or not approvable.

There is still a little before Chronic Fatigue Syndrome Patients will their chance to decide whether Ampligen will be a beneficial. But if i read everything correctly, it seems like it may be within a year(hopefully). But, even if the drug does only give modest improvements, that fact that an FDA approved drug can treat CFS patients, legitamizes the disease itself.