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May 16, 2005
Alferon LDO Now in Human Clinical Trials As Experimental Antiviral/Immunodulatory Therapy
…. Accelerated evaluation of a synergistic cocktail of eight different alpha-interferons to potentially trigger “guardian angel” genes


Philadelphia, PA, Monday, May 16, 2005: Hemispherx Biopharma, Inc. (AMEX: HEB) has initiated clinical trials as part of an accelerated evaluation of the experimental bio-therapeutic Alferon LDO [Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)] as a potential new experimental therapy for Avian Flu and other lethal viral diseases, which have high acute death rates.

Clinical trials in human volunteers (being conducted in both the U.S. at Drexel University, Philadelphia, and shortly to commence in Hong Kong at the Princess Margaret Hospital) are designed to determine whether Alferon N, delivered in a new, experimental oral drug delivery format, can resuscitate the broad-spectrum antiviral and immunostimulatory genes. These human genes are shut down by acute lethal viral infections such as avian flu and smallpox.

The Center for Disease Control and Prevention (CDC) recently announced “risky” in vitro experiments, which simulate the mixing and matching of genes between the avian flu virus, and a common human flu virus. Such ‘recombination’ might grow into a pandemic highlighting the intense present scientific interest in this molecular biological topic.

Dr. Brian Williams a world renowned researcher at the Cleveland Clinic will be the research collaborator in the clinical trials. His research group already pioneered the identification of many of the interferon (IFN) related genes which are the subject of the present clinical investigations. In the prospective clinical tests systemic blood samples will be sampled for gene activation after brief exposure of Alferon N to the buccal (oral) mucosa of volunteers.

Immunity against viruses can typically take two forms: innate immunity and ‘learned’ (adaptive) immunity. The NIH is currently pursuing adaptive immunity by launching nationwide vaccine testing against the avian flu. Vaccines are promising, but may have the distinct disadvantage of minimal value in individual post-viral exposure; vaccines can also become useless in the event of viral mutation (classically seen with the flu viruses and HIV/AIDS viruses).

In contrast, the innate immune system, having evolved over millennia to function within moments of encountering viruses, can prevent or ameliorate infections in animal models. Also, because innate immunity operates via immune “cascades”, i.e., multiple steps of viral blockade, mutation to resistance by the virus may be more difficult.

Hemispherx, and several other Biopharma companies, are evaluating genetic-based experimental approaches to potentially reverse the high death rate. “Guardian angel genes” is a term of art applied to critically important genes, including the IFN modulated genes, which in nature apparently can protect the human host from acute death due to overwhelming viral injection. Reconstruction experiments conducted by the CDC have pointed towards the disablement of these IFN genes as the proximate cause of death.

About Hemispherx

Hemispherx Biopharma, based in Philadelphia, is a biopharma company engaged in the manufacture and clinical development of new drug entities. Hemispherx’s flagship products include Alferon N® and the experimental antiviral products, Ampligen® and OragensÔ. These novel Alferon-N proteins, commercially available for a category of STD infection, and experimental nucleic acids are being developed for globally important chronic diseases and disorders of the immune system including HPV, HIV, CFS and Hepatitis and avian flu. Its four major technology platforms include large-and small-agent components for potential treatment of various chronic viral infections, and are being developed with various corporate, governmental and academic collaborators worldwide. Hemispherx has more than 200 patents comprising its core intellectual property estate, a fully commercialized product (Alferon N®) and GMP certified manufacturing facilities for its novel pharma products. For more information please visit www.hemispherx.net


Contact:
Hemispherx Biopharma, Inc.,
Dianne Will, Investor Relations
(518) 398-6222, Fax: (518) 398-6369

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 Ampligen and Oragens) 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. Only Clinical Studies under well-controlled conditions can establish efficacy and safety of any product. Clinical trials for other potential indications of the approved biologic Alferon N do not imply that the product will ever be specifically approved commercially for these other treatment indications including avian flu.