PHILADELPHIA, May 16 /PRNewswire/ -- HemispheRx Biopharma Inc. (Nasdaq:
HEMXU) announced today that Helix Biopharma Corp of British Columbia, Canada,
has been authorized to supply Ampligen(R) under the Emergency Drug Release
Program of Canada's Health Protection Branch. This authorization means that
the drug will become available in Canada to sufferers of Human
Immuno-deficiency Virus (HIV) infection.  On May 3, 1996, HemispheRx
announced that the Health Protection Board had made Ampligen immediately
available in Canada to sufferers of Chronic Fatigue Syndrome (CFS), another
extremely debilitating chronic viral condition with no previously approved
treatments in the U.S. or Canada. 

HemispheRx reported at the University of California's Fourth Annual
"Frontiers of HIV Therapy" conference on March 8, 1996, new laboratory and
clinical evaluations of the "Theta Switch" theory as an important
immunological mechanism of long-term survival in HIV-infected individuals.
HemispheRx reported that its nucleic acid compound, Ampligen, in conjunction
with AZT, switched a significant percentage of HIV-infected clinical trial
subjects from an unresponsive Theta status to a responsive one.  The reported
studies involved approximately 70 individuals affected with HIV infection.
Results of research conducted by the U.S. military suggest that HIV-infected
subjects' median survival advantage may shift from 34 months to 69 months,
apparently as a direct result of Theta switching.  AZT alone was not found to
significantly improve Theta Switch responsiveness. 

The Theta Switch causes a cascade of immune cells to "track" or channel down
pathways of either mounting cellular defenses or secretory (antibody)
defenses.  In HIV disease, the cellular defenses may be the more vital in
predicting the quality of life and survival duration. Type 1 Theta response,
also called a DTH or a positive skin test response, has been historically
associated with a "survival advantage," especially in the recent longitudinal
studies of HIV-infected military personnel evaluated by the U.S. Military
Consortium for Applied Retroviral Research and the United States' Veterans
Administration Study Group. 

Previously, researchers had no drug products or experimental tools which
unequivocally directed the immune system down the desirable Theta 1 path.
Indeed, the immunological path selected in any single HIV- infected
individual appeared to be largely dictated by apparently random events
occurring during the course of the disease.  However, researchers at
HemispheRx showed that its patented nucleic acid (NA) products could drive
the immune reaction in the apparently correct direction by selectively
controlling the Theta Switch.  This was demonstrated in vivo by the ability
of certain NAs to throw the Theta Switch correctly and to elicit the
production of a specific biological "cocktail" of cytokines, including
interferon (IFN), interleukin (IL) 2 and IL-12, which are the mediators or
the biochemical workhorses of the Theta 1 Switch. 

On April 17, 1996, HemispheRx, the developer and manufacturer of Ampligen
reported that it had entered into a strategic alliance with Helix for the
joint development of Ampligen in Canada.  Helix is currently in discussion
with HemispheRx concerning carrying out clinical trials in Canada in order to
assess further the potential value of Ampligen in the treatment of HIV.
HemispheRx now plans to evaluate this immunological-based regimen in
conjunction with the newer classes of protease-based antiviral drugs which
alone can reduce the HIV viral concentration in blood by 99% for several
months.  However, recent reports suggest that, thereafter, resistant HIV
strains may emerge from these purely antiviral regimens.  By scheduling the
immunological and antiviral therapies in specific sequences, the researchers
plan to evaluate whether the elicitation of the Theta 1 Switch response at
the proper time will ameliorate the emergence of resistant HIV strains and
thereby further prolong the benefit periods in HIV disease. 

HemispheRx is a pharmaceutical company (with corporate headquarters in
Philadelphia, Pennsylvania, and manufacturing facilities in Rockville,
Maryland) engaged in the manufacture and global clinical development of new
drug entities of the nucleic acid class for chronic viral diseases and
disorders of the immune system.  To date, HemispheRx and its subsidiaries
have received over 230 patents internationally to establish its proprietary
position in NA and related drug technologies. 

CO:  HemispheRx Biopharma Inc 

ST:  Pennsylvania, Maryland 

IN:  MTC 

SU: 

05/16/96 08:53 EDT