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Hemispherx Filed Patent Applications to Combat SARS.


Business Editors/Health/Medical Writers

PHILADELPHIA--(BUSINESS WIRE)--May 27, 2003

Hemispherx Confirms Filing Patent Applications for the Use of

Alferon N Injection(R) and Ampligen(R) for treating SARS

Hemispherx Biopharma, Inc. (AMEX AMEX

See: American Stock Exchange
: HEB HEB Hebrew
HEB Hurst-Euless-Bedford (Texas)
HEB Hot Electron Bolometer
HEB Hindu Endowments Board (Singapore)
HEB Here Everything's Better
HEB High-Energy Beam
HEB High Energy Biscuit
) announced today that it filed patent applications covering the use of both of its lead compounds, Alferon N Injection(R) and Ampligen(R) for the potential treatment and prevention of severe acute respiratory syndrome Severe Acute Respiratory Syndrome (SARS) Definition

Severe acute respiratory syndrome (SARS) is the first emergent and highly transmissible viral disease to appear during the twenty-first century.
 (SARS).

Independent studies have identified Alferon N, a natural source, multispecies alpha interferon product, and Ampligen(R), an experimental, double stranded RNA RNA: see nucleic acid.
RNA
 in full ribonucleic acid

One of the two main types of nucleic acid (the other being DNA), which functions in cellular protein synthesis in all living cells and replaces DNA as the carrier of genetic
 drug acting potentially as an immunomodulator and antiviral, as first candidates for potentially treating SARS. The patent applications that have been filed provide procedures for combating the effects of coronavirus-induced conditions by the administration of Alferon N Injection(R) or Ampligen(R) or in combination therapy.

The Company believes it has filed its patent applications in a timely matter with respect to its Alferon and Ampligen technologies, protecting its intellectual property and enhancing shareholder value. The patent procedure has also been mentioned in the press release of May 13, 2003, before any other company released potentially competitive patent applications. Hemispherx has a large knowledge and expertise in the procedures of filing patents and has built up, with close to 400 patents, potentially one of the largest patent portfolio in the biotech industry. Due to the acquisition of the Alferon technology, the Company has further enlarged its world wide patent estate with respect to Alferon N Injection(R), including several process patents related to the manufacturing of natural alpha interferon.

About the treatment mechanism

Individuals with chronic diseases or the aged, both conditions associated with weakened cell immunity, are at great risk to accelerated death from SARS. The "spike protein" of coronaviruses further damages the body's immune apparatus, thus facilitating an increase in virus multiplication. The natural immune "cascade" triggered by the patented compounds may modulate these critical deficiencies in host defense.

About Ampligen(R)

Ampligen(R) is an experimental, double stranded RNA drug acting potentially as an immunomodulator and antiviral. Based on in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment.

in vi·tro
adj.
In an artificial environment outside a living organism.
 studies, Ampligen(R) is believed to stimulate the immune system as well as destroy viruses directly. The product is currently in Phase 3 clinical trials for the potential treatment of Chronic Fatigue Syndrome chronic fatigue syndrome (CFS), collection of persistent, debilitating symptoms, the most notable of which is severe, lasting fatigue. In other countries it is known variously as myalgic encephalomyelitis, chronic fatigue and immune dysfunction syndrome, and  (CFS CFS
abbr.
chronic fatigue syndrome


CFS,
n.pr See syndrome, chronic fatigue.

CFS Chronic fatigue syndrome, see there
) and in two Phase 2b clinical trials for the potential treatment of HIV/AIDS HIV/AIDS Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome . SARS, which is believed to be a coronavirus coronavirus /co·ro·na·vi·rus/ (ko-ro´nah-vi?rus) any virus belonging to the family Coronaviridae.
Coronavirus /Co·ro·na·vi·rus/ (ko-ro´nah-vi?rus 
 and the HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States.  virus, both belong to the group of ribose nucleic acid (RNA) viruses which frequently change and mutate mu·tate  
intr. & tr.v. mu·tat·ed, mu·tat·ing, mu·tates
To undergo or cause to undergo mutation.



[Latin m
. On May 21, 2003 the Company announced the promising data on a NIH "Not invented here." See digispeak.

NIH - The United States National Institutes of Health.
 sponsored study on SARS finding Ampligen(R) having unusually high and consistent antiviral activity against human coronavirus. The study found Ampligen(R) among the most active drug candidates, compared to approximately 70 others.

About Alferon N

Alferon N (Interferon alfa-n3, human leukocyte leukocyte (l`kəsīt'): see blood.
leukocyte
 or white blood cell or white corpuscle
 derived) is a highly purified, natural source, glycosylated, multispecies alpha interferon product, composed of eight forms of high purified alpha interferon. It is the only natural-source, multispecies alpha interferon currently sold in the U.S. for the treatment of a specific indication of STD (Subscriber Trunk Dialing) Long distance dialing outside of the U.S. that does not require operator intervention. STD prefix codes are required and billing is based on call units, which are a fixed amount of money in the currency of that country.  (refractory condylomata acuminata) and is also approved for sale in certain other countries, including Hong Kong (Peoples Republic of China) and Singapore. On May 19, 2003 the Company reported positive data from an independent study evaluating the effect of Alferon N in the treatment of pig coronavirus (animal model of SARS). The clinical study showed substantial greater survival rates of treated piglets compared with the control group, receiving placebo. Since human SARS apparently has its roots in animal coronavirus, the Company believes that the drug's effect in the animal study may be relevant to potential human applicability.

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 HPV human papillomavirus.

HPV
abbr.
human papilloma virus


Human papilloma virus (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 GMP (guanosine monophosphate): see guanine.  certified manufacturing facilities for its novel pharma products. For more information please visit 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(R) and Oragens(TM)) 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 Alferon(R) do not imply that the product will ever be specifically approved commercially for these other treatment indications. The Alferon(R) 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.
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Publication:Business Wire
Geographic Code:1USA
Date:May 27, 2003
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