PHILADELPHIA, May 7 /PRNewswire/ -- Hemispherx Biopharma, Inc. (Nasdaq: 
HEMX) announced today the U.S. Food and Drug Administration (FDA) has 
authorized the Company to charge, on a cost recovery basis, for its 
proprietary drug, Ampligen(R), which is to be used in an open-label 
clinical trial in patients suffering from Chronic Fatigue 
Syndrome/Chronic Fatigue Immune Dysfunction Syndrome (CFS/CFIDS).  
This open-label clinical trial will begin immediately.  Initially the 
Company will treat twenty patients under this program.  The drug 
pricing was established under FDA guidelines and enables HEMX to 
recover costs of manufacture, research, development and handling of 
the expanded access program.  HEMX also said that it had agreed with 
the FDA to conduct a placebo-controlled clinical trial of its 
proprietary drug, Ampligen, in patients suffering from CFS/CFIDS.  
The protocol for the trial is under discussion with the FDA. 

CFS/CFIDS 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 are an estimated 500,000 or more CFS/CFIDS 
sufferers in the United States alone. 

Hemispherx is the only company that has applied to the FDA to 
investigate a treatment for CFS/CFIDS at the Phase III level.  
Ampligen has been studied in earlier trials for CFS/CFIDS in the U.S. 
and is currently being used in an open-label CFS/CFIDS trial in 
Belgium which was reported last October at the 1996 American 
Association for CFS-Research Conference in San Francisco. Clinical 
benefit response rates of that study were reported by Professor Kenny 
DeMeirleir as a composite measure of symptomatic improvement and 
performance status. 

Cost recovery Investigational New Drug (IND) regulations were created 
by the FDA to allow access to experimental drugs in a controlled 
scientific environment before full FDA approval is authorized for 
specific pharmacologic therapies for persons with a serious or life-
threatening illness, such as CFS/CFIDS, AIDS or cancer. 

Hemispherx is a biopharmaceutical company engaged in the manufacture 
and global clinical development of new drug 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 several hundred patents internationally to protect its 
proprietary position in NA and related drug technologies.  
Pharmacia/Upjohn and South African Breweries/Bioclones are the 
strategic partners who cooperate with Hemispherx in the overall drug 
manufacturing process. 

SOURCE  Hemispherx Biopharma, Inc. 

CO:  Hemispherx Biopharma, Inc.; U.S. Food and Drug Administration 

ST:  Pennsylvania 

IN:  MTC 

SU:  PDT 

05/07/97 08:32 EDT http://www.prnewswire.com