|November 13, 2003
|HEMISPHERX BIOPHARMA BIOTERROR PROGRAM COVERED AT FEDERAL BIODEFENSE RESEARCH FY 2004 CONFERENCE
| Company’s Bioterror Treatment/Prevention Initiative Introduced in Project BioShield
Philadelphia, PA, Thursday, November 13, 2003: Hemispherx Biopharma, Inc. (AMEX: HEB) announced today that at the Federal Biodefense Research FY 2004 Conference at the Ronald Reagan Building & International Trade Center in Washington, DC, November 12-13, 2003, the Company’s Bioterror Program was discussed as part of the Project BioShield Panel Discussion.
The Company is developing a complete Bioterror Program entitled “Natural Immunological Broad-Spectrum Antiviral Approach towards Bioterror Agents.” The spectrum of Bioterror agents is large and may be infinite, which makes it extremely difficult to identify the attacking agent in a short period of time. When such an attack happens, the first line of immune defense in the attacked individuals should be strengthened with a broad-spectrum therapeutic intervention and the population at risk should be protected with a broad-spectrum antiviral prevention initiative.
Hemispherx Biopharma’s experimental program to shield the population, civilian and/or military, from a Bioterror attack is based upon four different compounds, Alferon N® and Ampligen® as potential treatments, and Alferon LDO® and Oragen™, both taken orally, as prevention candidates. Natural biologics such as natural interferon, which are found in the human body, could be excellent candidates to combat Bioterror attacks because of their broad-spectrum immunological and antiviral approach. Ampligen® could potentially amplify the activity of interferon. While interferon up-regulates certain intracellular pathways, dsRNA’s, like Ampligen®, are required to fully activate these important antiviral pathways. Only clinical studies under well controlled conditions can define efficacy and safety of new candidate drugs including those described in this report.
About Federal Biodefense Research FY 2004
The conference provided a comprehensive briefing on the government’s biodefense research priorities, programs, and funding to academic, industry, and government representatives. The event featured key people from the National Institute of Health, Department of Defense, Center for Disease Control, Department of Health and Human Services, Department of Homeland Security, Food and Drug Administration, DARPA, Environmental Protection Agency, National Science Foundation, and the Department of Agriculture who described ways to enhance government/private cooperation and partnerships.
About Project BioShield
BioShield is a $ 5.6 billion Department of Homeland Security and Health and Human Services program to encourage the development of drugs that could be used to prevent or treat diseases emerging from a Bioterror attack.
About Ampligen® and Alferon N®
Ampligen® is an experimental, double stranded RNA drug acting potentially as an immunomodulator and antiviral. Based on in vitro studies, Ampligen® 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 (CFS) and in two Phase 2b clinical trials for the potential treatment of HIV/AIDS.
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 genital HPV (refractory condylomata acuminata) and is also approved for sale in certain other countries, including Hong Kong (People’s Republic of China) and Singapore.
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. 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 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. 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. 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.