this is overlooked but key for heb, we need a way to diagnose cfs if you cant prove someone has cfs we will never get health insurance companies to pay for ampligen PHILADELPHIA, PA--(HealthWire)--December 6, 1996--
Diagen(R) is First Chronic Fatigue Syndrome Diagnostic
HEMISPHERx BIOPHARMA, INC. (NASDAQ: HEMX) today announced that it received patent approval on its Chronic Fatigue Syndrome (CFS) diagnostic, Diagen(R), in ten leading European countries. The Company has applied for similar patents in the U.S. The Company believes that the Diagen technology should be the first accurate and direct diagnostic for CFS, thus creating the stage for immediate medical treatments.
Currently, CFS diagnosis is a costly process of elimination. Patients undergo a battery of tests to rule out other diseases. The newly patented diagnostic efficiently tests a patient's peripheral blood cells for specific immune deficits believed to be characteristic of CFS and evidencing an abnormal viral "footprint." Diagen is a single test, therefore making diagnosis is quicker and overall less expensive than the current diagnostic path. "Until now, CFS sufferers have had no direct diagnosis or direct treatment of CFS," stated Dr. Carter, CEO of HEMISPHERx BIOPHARMA, INC. "With the Diagen patents, HEMISPHERx will be able to offer an improved, more accurate diagnosis, identifying which patients are candidates for CFS treatments immediately."
The patent for Diagen, entitled "Diagnosis and Treatment of Neurocognitive Disorders," has been approved in Belgium, France, Germany, Italy, Luxembourg, Netherlands, Spain, Sweden, Switzerland including Liechtenstein, and the United Kingdom. The Company is currently reviewing options for distribution within these countries and expects that the test will be available in the near future. "We estimate a considerable market for a CFS diagnostic in Europe, which represents about 40% of the worldwide pharmaceutical market," continued Dr. Carter.
"Chronic Fatigue is an enigmatic syndrome," explained Dr. Carter. "But we are now able to group the patients varying symptoms, treating them as a whole rather than catering to each part, to test specifically for CFS." CFS is a multisystem syndrome characterized by months of debilitating fatigue frequently associated with myalgia, headache, sore throat, low grade fever, and tender lymph nodes. The illness interferes with everyday simple tasks such as walking, driving, and remembering appointments. In severe cases, it causes patients to become bedridden. There is an estimated 400,000 CFS sufferers in the United States alone.
As previously reported, HEMISPHERx is successfully testing the first CFS specific drug treatment, Ampligen(R), in Belgium. According to Dr. Kenneth DeMerlier, Ph.D., M.D., head of the Belgium treatment programs, approximately 80% of patients in the program are experiencing complete clinical recovery. Recent U.S. studies indicate that only 2% of CFS sufferers can expect spontaneous improvement to normal function and activity levels. Ampligen is currently available in Canada under the Emergency Drug Release Program, at the request of Canadian physicians.
HEMISPHERx is a pharmaceutical company engaged in the manufacture and global clinical development of drugs entities in the nucleic acid (NA) class for chronic viral diseases and disorders of the immune system. To date, HEMISPHERx and its subsidiaries have received over 200 patents internationally to protect its proprietary position in NA and related drug technologies.
CONTACT:
HEMISPHERx BIOPHARMA, INC.
William A. Carter
(215) 988-0080
or
VMW, Inc.
Vicki Miles Weiner
(212) 605-3140
VMWeiner@aol.com
KEYWORD: PENNSYLVANIA
INDUSTRY KEYWORD: PHARMACEUTICAL
BW1080 DEC 06,1996
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