|October 14, 2003
|HEMISPHERX BIOPHARMA EXPANDS SARS PREVENTION/TREATMENT INITIATIVE
|Prior to Anticipated Fall/Winter Outbreak also widens Distribution and Clinical Networks
Philadelphia, PA, Tuesday, October 14, 2003: Hemispherx Biopharma, Inc. (AMEX: HEB) announced today that, based on promising new results just obtained from National Institutes of Health sponsored, independent laboratory research on the human SARS agent and related coronaviruses, it will stockpile various drug delivery formats (injectible and/or oral) of its two lead compounds, Alferon N® and Ampligen®. Both products are being manufactured in the U.S.A., including novel drug delivery formats of Alferon N® suitable for providing potential antiviral protection at the actual point of viral entry (termed “Alferon LDO”). The novel prevention program is designed to prevent spread of SARS once the sentinel, or first, cases are identified.
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. for the treatment of refractory papilloma infections (HPV) and is also approved for sale by various regulatory agencies worldwide. By contrast, recombinant, non-natural source, interferon is composed of only one form and can cause allergic (antibody formation) reactions in man.
Natural Interferon Induction
Ampligen® is an experimental interferon (IFN) inducer and co-activator of dormant cellular immune systems, which induces numerous natural IFNs. The product is currently in Phase 3 clinical trials for the potential treatment of Chronic Fatigue Syndrome (CFS) and in two Phase 2b clinical trials for the potential treatment of HIV/AIDS. Results of the Phase 3 trial in CFS are expected to be reported in the next coming months as the final patients pass thru 40 weeks of the active treatment phase.
Prevention & Treatment Implementation
Various governmental agencies worldwide have predicted a near term resurgence of SARS. Presently, a Hemispherx’ team is in the Far East preparing logistically to deal with possible SARS outbreaks, by meeting with local teams able to deliver the products to needed areas in cost-effective, timely manner.
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
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. 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.