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June 03, 2003
HEMISPHERX REPORTS DATA ON ALFERON AT SARS CONFERENCE
Clinical Study of Relative Safety Profiles of Natural IFN over Recombinant IFN suggests less Drug Induced Morbidity


Philadelphia, PA, Monday, June 02, 2003: Hemispherx Biopharma, Inc. (AMEX: HEB) announced today that it has unveiled previously undisclosed human volunteer data during its presentation at the “Anti-SARS Forum”, held at the University of Pennsylvania on Sunday June 1, 2003. The comparative clinical safety study compares the side effects of its lead compound, Alferon N Injection®, a highly purified, natural source, multispecies alpha interferon product, derived from human white blood cells, with recombinant, bacteria derived, interferon (rIFN), Intron® A. The two products were compared at equivalent biologically active amounts.

Study Design
A comparative safety study of Alferon N Injection®, natural alpha interferon, and Intron® A, recombinant interferon, was performed in healthy volunteers. The study was double-blinded with 14 individuals randomized to receive Intron® A while 15 received Alferon N Injection®. The patient population was normal volunteers ages 18-50 with no prior interferon treatment and no evidence of a viral disease during the last 4 weeks. The treatment consisted of 5 million units of Alferon N Injection® or Intron® A five times per week for two weeks. The objective was to evaluate the occurrence and severity of adverse reactions. The study was conducted by an independent Clinical Research Organization (“CRO”).

Results of Comparative Safety Study
The incidence of body chills was significantly lower in the volunteers receiving the natural Alferon N Injection®. Only 1 individual (7%) treated with Alferon N experienced chills compared to 11 individuals (79%) treated with Intron® A. The difference (p<0.001) was highly statistically significant. The incidence of fever (fever>100ºF) was also significantly lower in the volunteers receiving Alferon N Injection®. Only 2 subjects (13%) receiving Alferon experienced fever over 100ºF during the two week test as compared to 9 subjects (64%) treated with Intron® A . The difference (p=0.007) was highly significant statistically.

Molecular Pathogenesis of SARS
The molecular pathogenesis of SARS is not yet fully elucidated. However, in certain virulent and very aggressive viral infections (e.g., smallpox) the body’s IFN system is overwhelmed by viral specific products which kill or inactivate the body defenses. One possible therapeutic approach is to replace the body’s IFN molecules which have, in effect, been killed by the incoming, virulent, viral attack. Obviously, the potency and safety profile of the “replacement” IFNs may become of paramount importance in these possible treatment scenarios.
Potency studies: independent studies, performed at Walter Reed Army Medical Facility, on another virus (HIV) on a blind basis have shown Alferon N to be up to 100-fold more effective than equal concentrations of two different recombinant IFNs for inhibition of virus replication in primary human peripheral blood mononuclear cells. Volunteer and/or animal experimentation and/or lab tests do not necessarily predict efficacy and safety in the actual clinical disease category which can only be reliably shown by well-controlled clinical tests in the disease itself.

Possible significance to SARS
SARS is an acute life threatening illness associated with high fever, chills and generalized weakness. Many patients require artificial ventilation support to increase their chances of survival. Typically the physiological stress is so great that blood oxygen levels fall and 20 to 50% of the infected patients die within a few days or weeks.
Amplification / Augmentation of IFN Antiviral Action.
Data presented at the SARS Symposium also demonstrate how the experimental immunotherapeutic, Ampligen®, can potentially override a virus-induced IFN “blockade”. In addition, in some model cell-virus systems, Ampligen® can by-pass the blockade altogether by a process called “allosteric activation”.

About the Company’s SARS programs
Hemispherx has in development several programs to potentially combat SARS with the use of its lead compounds Alferon N Injection®, a natural source, multispecies alpha interferon product, and Ampligen®, a double stranded RNA experimental product acting potentially as an immunomodulator and antiviral. The programs cover procedures for combating the effects of coronavirus-induced conditions by the administration of Alferon N Injection® or the experimental compound Ampligen® or in combination therapy. The Company will release updates on these programs in due time. Only clinical testing under well-controlled conditions can determine efficacy and safety on any entity including Alferon N Injection® and Ampligen®.

About Hemispherx
Hemispherx Biopharma, based in Philadelphia, is a biopharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of viral and immune-based chronic disorders. Its flagship products include Alferon and the experimental immunotherapeutics/antivirals Ampligen and Oragens. These novel proteins, approved for a category of STD infection, and experimental nucleic acids are being developed for globally important chronic viral diseases and disorders of the immune system including HPV, HIV, CFS and Hepatitis. Its platform technology includes large and small agent components for potential treatment of various chronic viral infections. Hemispherx has approximately 400 patents comprising its core intellectual property estate, a fully commercialized product (Alferon N) and GMP certified manufacturing facilities for its novel pharma products. The Company plans global clinical trials in the SARS disease arena where it has a proprietary position and the disease represents a major threat to human welfare. For more information please visit www.hemispherx.net.


Contact:
Hemispherx Biopharma, Inc.,
Dianne Will, Investor Relations
(518) 398-6222, Fax: (518) 398-6223

HEB's Web Site: www.hemispherx.net


Information contained in this news release other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the company (including AmpligenÒ and Oragensä) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Clinical trials for other potential indications of the approved biologic AlferonÒ do not imply that the product will ever be specifically approved commercially for these other treatment indications including SARS. The Alferon® asset for overseas sales for a category of STD is currently being acquired by the Company as part of a multi-step purchase contract of inventory, intellectual property, commercial licenses and GMP approved facilities, which house the biological operations.