|August 11, 2003
|HEMISPHERX BIOPHARMA ENTERS INTO AGREEMENT WITH THE JOHANN WOLFGANG GOETHE UNIVERSITY, INSTITUTE OF VIROLOGY
| Independent US Scientific Panel Recommends Further Evaluation of Ampligen® for SARS
Philadelphia, PA, Monday, August 11, 2003: Hemispherx Biopharma, Inc. (AMEX: HEB) announced today that it has entered into a Research Project Agreement with the Institute for Medical Virology, Johann Wolfgang Goethe University Hospital, Frankfurt am Main, Germany (www.klinik.uni-frankfurt.de). The Institute is one of the largest molecular biological centers for virus diagnostic in the world with emphasis on research in SARS, HIV/AIDS, Hepatitis, Chlamydia infections and cancer therapy and has requested the Company to use its lead compounds for research.
Parameters of Collaboration
The Research Project will consist of work conducted utilizing the experimental Phase 3 immunotherapeutic Ampligen® and Alferon®, a natural high purity alpha interferon approved by the FDA and various non-US regulatory authorities for the treatment of genital HPV, Condylomata Acuminata. The studies will evaluate the antiviral activity of Ampligen® and Alferon® alone and in combination against the SARS virus. Recently, the Institute has evaluated the antiviral effect of the three other interferon types against SARS coronavirus in vero cells. Research will also be conducted in the field of anti-cancer therapy with Alferon®. In recent studies, the Institute for Medical Virology showed that interferon-alpha in combination with Valproic yield strong synergistic effects against human neuroectodermal (brain) tumors. Furthermore, different studies will compare the effects of Ampligen in anti-tumor assays.
NIH Panel Formally Recommends Further Ampligen/SARS Testing
The Company also received a report of the National Institutes of Health (NIH), dated July 18, 2003, concerning therapeutic Ampligen activity against Human Coronavirus OC-43. In the report, an independent panel of virology experts recommended to NIH further antiviral testing of the experimental agent Ampligen against the SARS virus.
About SARS and Seasonal Outbreaks of Infection
In the last several months, Severe Acute Respiratory Syndrome (SARS) has impacted thousands of people worldwide, especially in China and Hong Kong. Although the epidemic seems to be under control, several organizations are still searching for a potential treatment in the event of a future outbreak. SARS, being a different class of coronavirus infection is very likely to be a seasonal virus. Coronavirus infection accounts for approximately 30 % of all common colds in humans. Most colds occur during the fall and winter seasons. Beginning early September, the incidence of common colds typically escalates and remains high until late spring. This period is known as the “cold season” and is believed to be the result of a broad range of causes.
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, Hepatitis and SARS. 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) 398-6223
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.