January 26, 2004 10:00 AM US Eastern Timezone
PHILADELPHIA–(BUSINESS WIRE)–Jan. 26, 2004–
Data Show Ampligen Superior to Both Recombinant and Pegelated Interferons for Life – Threatening Inflammation of the Heart
Hemispherx Biopharma, Inc. (AMEX: HEB) announced today that the results from an independent study, conducted by Professor Johan Neyts of the Rega Institute, KUL, Leuven Belgium, have been publicized in “Antimicrobial Agents and Chemotherapy”, Jan. 2004, Vol 48, p. 267 – 274. The study, “The Interferon Inducer Ampligen Markedly Protects Mice against Coxsackie B3 Virus-Induced Myocarditis.” was conducted in an animal model of human disease and suggests that Hemispherx’s Ampligen(R) was effective in treating Coxsackie virus.
The Coxsackie virus causes a fulminant myocarditis, which is a life threatening inflammation of the heart. The treatment with the experimental compound Ampligen(R) decreased inflamed foci by approximately 98% and was 10 times superior to recombinant interferon (rIFN) and 15 times better than pegelated interferon (PEG-IFN). Viral concentrations in the heart were decreased more than 99% by Ampligen(R) and serial EKGs evidenced much improved cardiac performance by Ampligen(R) treatment. rIFN and PEG-IFN are the present world-wide standard of care in several major human viral infections.
Ampligen(R) is an experimental, double stranded RNA product acting potentially as an immunomodulator and antiviral. The product is currently in Phase 3 clinical trial for the treatment of Chronic Fatigue Syndrome and in two Phase 2b clinical trials for the treatment of HIV/AIDS.
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(R) and the experimental immunotherapeutics/antivirals Ampligen(R) and Oragens(TM). 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(R)) and GMP 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. 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 Alferon(R) do not imply that the product will ever be specifically approved commercially for these other treatment indications including SARS.
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.
Hemispherx Biopharma, Inc.
Dianne Will, 518/398-6222
Cormac Glynn, 212/732-4300