|June 23, 2003
|HEMISPHERX BIOPHARMA ANNOUNCES INDEPENDENT STUDY THAT SHOWS AMPLIGEN® SUPERIOR TO OTHER ANTIVIRALS
|Prof. Neyts receives prestigious Prusoff Award for research potentially applicable to SARS
Philadelphia, PA, Monday, June 23, 2003: Hemispherx Biopharma, Inc. (AMEX: HEB) announced today that the Antiviral Research Group led by Professor Johan Neyts of the Rega Institute, KUL, Leuven, Belgium has just reported a new study which screened several immune-based compounds for potential activity against Coxsackie virus, a human pathogenic agent. The study identifies Ampligen®, an important flagship investigational immunotherapeutic, as being superior to other antivirals, including PolyIC, recombinant interferon and pegelated interferon. Professor Johan Neyts received this year’s prestigious Prusoff Young Investigator Lecture Award, based on his outstanding work in antiviral research.
About the Study
The data may be directly applicable to humans since Coxsackie can cause myocarditis in humans.
The Coxsackie virus causes a fulminant myocarditis (inflammation of heart muscle) in mice within 6 days of infection (Horowitz et al Nature Medicine, 2000). Ampligen® was far superior to other antivirals, such as interferon (IFN), a special new potent form of IFN termed PEG-IFN and PolyIC. The experimental compound Ampligen® decreased inflamed foci by approximately 98% and was 10 times superior to recombinant IFN and 15 times to PEG-IFN. Viral concentrations in heart were decreased more than 99% by Ampligen® and serial EKGs evidenced much improved cardiac performance by Ampligen® treatment. The proportions of myocarditis foci (inflammations) per heart, expressed as a percentage were: IFN 2.22%, PEG-IFN 3.39%, PolyIC 0.73% and Ampligen® 0.22%. The mock (placebo-control) animals had 10%.
No contracts, grants, financial compensation or other means of indirect support were provided to the research team or to the academic institution.
About the William Prusoff Young Investigator Lecture Award
The Bristol-Myers Squibb Company (BMS) has endowed the William Prusoff Young Investigator Lecture Award, which is awarded annually by the International Society for Antiviral Research (ISAR). The Society’s membership is over 700 and represents the Who’s Who of scientists involved in antiviral research. ISAR is an international recognized organization for scientists, involved in antiviral research and offers a forum for the exchange of scientific information. The contributions of William H. Prusoff, Ph.D., Professor Emeritus and Senior Research Scientist in Pharmacology, Yale University, to the development of antivirals and their clinical use are legendary. Annually the award is given to one outstanding young scientist, from among 700 potential candidates, who has demonstrated dedication and excellence in the field of antiviral research and future potential for contribution to the field and the society.
About the Study and SARS
The present study utilizes a different virus, myocarditis virus, to determine if protection of critical internal organs in animals (mice) is possible with Ampligen®. SARS is now believed to be a multi-system disease according to recent publications in Lancet, an internationally recognized medical journal. According to the Asian based clinical researchers, SARS damages many internal organs (liver, spleen) by attacking and destroying them as it progresses to a terminal pulmonary phase. The present study suggests that Ampligen® may be able to protect various vital organs, including heart and potential viscera protection, thereby providing a potential broad-spectrum anti viral defense mechanism that may enable a multi-organ protection.
About the Company’s SARS programs
Hemispherx has in development several programs to potentially combat SARS with the use of its lead compounds Alferon N Injection®, a natural source, multispecies alpha interferon product, and Ampligen®, a double stranded RNA experimental product acting potentially as an immunomodulator and antiviral. The programs cover procedures for combating the effects of coronavirus-induced conditions by the administration of Alferon N Injection® or the experimental compound Ampligen® or in combination therapy. The Company releases updates on these programs from time to time. Only clinical testing under well-controlled conditions can determine efficacy and safety on any entity including Alferon N Injection® and Ampligen® in SARS.
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 potential threat to human welfare. For more information please visit www.hemispherx.net
Hemispherx Biopharma, Inc.,
Dianne Will, Investor Relations
(518) 398-6222, Fax: (518) 398-6223
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. 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.