Drug company Hemispherx Biopharma, Inc. announces applications for its experimental therapeutic drug Ampligen to be approved as a treatment for Chronic Fatigue Syndrome.
The company said yesterday that it had filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) and was also moving forward with applications in other countries. Should the applications be approved it would be a landmark as Ampligen would become the first approved therapy for Chronic Fatigue Syndrome (CFS).
Currently the only recommendations for CFS are the use of cognitive behavioural therapy (CBT) and specially designed graded exercise programs to manage the condition.
It's reported that Hemispherx Biopharma's NDA submission includes four well-controlled clinical trials involving CFS patients. The trials are said to include more than 1,200 patients who were given a total of approximately 90,000 doses of Ampligen.
Should Ampligen be approved for use in CFS patients it would mark the end of a long developmental process. Way back in 1991 doctors specializing in Chronic Fatigue Syndrome were discussing the drug. In the first ever issue of The CFIDS Chronicle (Match 1991) Dr. Paul Cheney, a leading light in the CFS community, had this to say about Ampligen:
"Ampligen may be the ultimate in immune modulation and may shortly become the first scientific validated treatment for Chronic Fatigue Syndrome. Ampligen can down-regulate an anti-viral enzyme pathway, which is excessively turned on in most patients with Chronic Fatigue Syndrome. It also down-regulates the production of tumor-necrosis factor alpha...
"Besides its immune modulating effects, Ampligen also has direct anti-viral effects. Ampligen in our experience and in others, causes a significant imporvement in cognitive dysfunction and a general lessening of all symptoms seen in Chronic Fatigue Syndrome."
In the same year, the FDA declined requests for the drug to be made available for CFS patients. Now, after more than 16 years Ampligen may finally be approved as a mainstream treatment for the disease.
The drug company is now expected to start publishing the results of the clinical trials contained in the NDA in peer-reviewed medical and scientific journals. One study published earlier this year in the Journal of Immunology reported that Ampligen's effects may be a result of it binding to the human toll-like receptor 3 (TLR3) and activating subsequent signaling cascades. TLR3 is involved in the early detection of pathogens and the establishment of early immune defense mechanisms (innate immune system). The receptor may therefore be critical to the proper immune response to invading pathogens such as viruses.
As well as these conclusions and the effects reported by Dr. Cheney way back in 1991, it has also been noted that Ampligen increases natural killer cell numbers. These cells are a major part of the innate immune system and have a large role in defending us against viral attack. Natural killer cells are known to be low in CFS patients.