HemispheRx Biopharma, the company that is currently testing Ampligen on Belgian Chronic Fatigue Syndrome patients, recently received patent approval in 11 European countries for a CFS test.
The test, called Diagen, looks at a patient’s peripheral blood cells for specific immune deficits the company believes to be characteristics of CFS. HemispheRx Biopharma has applied for similar patents in the U.S. Patent approval is simply a way for a company to gain exclusivity to a medical device; it is not connected to the Federal Drug Administrations approval process.
The patent for Diagen, entitled “Diagnosis and Treatment of Neurocognitive Disorders,” has been approved in Belgium, France, Germany, Italy, Luxembourg, the Netherlands, Spain, Sweden, Switzerland, and the United Kingdom. “With the Diagen patients, HemispheRx will be able to offer an improved, more accurate diagnosis, identifying which patients are candidates for FCS treatments,” said CEO Dr. William Carter. Carter said his firm is now able to “group the patients’ varying symptoms, treating them as a whole rather that catering to each part, to test for CFS.”
HemispheRx Biopharma is currently testing its drug Ampligen on several hundred Belgian CFS patients inn an open label study. According to Dr. Kenneth DeMerlier, Ph.D., M.D., head of the Belgian treatment programs, approximately 80% of the study participants are experiencing “complete clinical recovery.”
While these small studies suggest Ampligen may be an effective treatment for some CFS patients, HemispheRx Biopharma has yet to mount a substantive, double-blind placebo controlled study of the drug on CFS patients. An earlier Phase II clinical trial which included 92 patients in 1990 ended after just 24 weeks, half the 48 weeks the company had planned.
According to Osler’s Web CFS author Hillary Johnson, the FDA called the data from that trial incomplete and said that there were “numerous deficiencies in the application.