|April 19, 2004
|HEMISPHERX BIOPHARMA REPORTS PUBLICATION SHOWING SUPERIOR ACTIVITY OF ALFERON AGAINST SARS
| Alferon Highest Activity Against SARS Among 19 Clinically Approved Compounds
Philadelphia, PA, Monday, April 19, 2004: Hemispherx Biopharma, Inc. (AMEX: HEB) announced today that the results of an independent study, conducted by the Genome Institute of Singapore, have been publicized in “Emerging Infectious Diseases”, Vol. 10, No. 4, April 2004. The study, “Inhibition of SARS Coronavirus Infection In Vitro with Clinically Approved Antiviral Drugs” suggests that Hemispherx’ s lead drug, Alferon N Injection, tested among 19 clinically approved compounds from several major antiviral pharmacologic classes, exhibits the most potent antiviral activity in an in-vitro model of SARS-CoV infection and is a potential drug for in vivo research. Companies contributing approved products included Roche, Schering-Plough, GlaxoSmithKline, Serono, Merck, Schering AG, Novartis and AstraZeneca.
The aim of the study was to investigate whether a panel of currently available antiviral agents would exhibit in vitro anti-SARS-CoV activity. A total of 19 drugs approved for clinical use in the treatment of viral infections (other than SARS) were tested in the study. They are representative compounds from most major antiviral pharmacologic classes that are currently commercially available: nucleoside analogs, interferons (including Intron A, Rebif, Roferon, Multiferon), protease inhibitors, reverse transcriptase inhibitors and neuraminidase inhibitors, used for a variety of diseases including influenza, HIV, Hepatitis C and other viral infections.
High titers of infectious SARS-CoV, originally derived from a respiratory sample of a SARS patient, were propagated on Vero E6 cells. The cytopathic endpoints (CPE) of SARS-CoV were evident within 24 hours after infection. Complete inhibition of the CPE was only observed in 4 of the 19 compounds. Complete inhibition, expressed as CIA100, was observed for Alferon N at 5000 IU/ml, the lowest level of all tested compounds. Only one other antiviral agent showed similar results; however this agent has no commercial license in the United States. Furthermore, no cytotoxicity of Alferon N was observed at or near inhibitory concentrations.
In conclusion, Alferon N has shown superior antiviral activity in an in vitro model and is a most promising candidate for in vivo research and clinical management of SARS-CoV infection and other emerging infectious diseases. Clinical studies are necessary to establish efficacy and safety of any new drugs.
About Alferon N
Alferon N (Interferon alfa-n3, human leukocyte 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., and is available for the treatment of refractory papilloma infections (HPV); it is also approved for sale by various regulatory agencies worldwide.
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 N® 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. For more information please visit www.hemispherx.net
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 AlferonÒ do not imply that the product will ever be specifically approved commercially for these other treatment indications, including SARS..