|April 29, 2003
|HEMISPHERX REPORTS EXPANDED HIV DATA ON AMPLIGEN AT THE 16th INTERNATIONAL CONFERENCE ON ANTIVIRAL RESEARCH
| Mean Duration of S.T.I. with Ampligen is 25+ weeks vs. 13 weeks for the Control Group. Increase in CD8+ cells in the Ampligen arm also observed.
Philadelphia, PA, Tuesday, April 29, 2003: Hemispherx Biopharma, Inc. (AMEX: HEB) announced today that on April 29, 2003 at the 16th International Conference on Antiviral Research, it presented the most recent data of its Phase IIb clinical trial, AMP 720, wherein patients’ antiviral regimens are interrupted and Ampligen® is substituted, called Strategic Treatment Interruption.
There is an urgent need for a treatment with unique mode of action to overcome the multi-drug resistance and serious drug toxicities of the current Highly Active Antiretroviral Therapy (HAART). This study is designed to address this issue by evaluating the administration of the Company’s lead experimental product, Ampligen, a double stranded RNA drug acting potentially both as an immunomodulator and antiviral.
In overview, the data presented showed that patients taken off HAART but given Ampligen, an experimental immunotherapeutic, continued to show virus levels below 5000 copies/ml for a mean time of 25 weeks and counting, whereas the control group, which was also taken off HAART (but not given Ampligen) had a HIV rebound with a mean of 13 weeks.
The data also suggests an increase in CD8+ cells in the Ampligen group suggesting an induction of immune cells that have potential to seek and may destroy cells infected with HIV. CD8+ cells are a specific type of T lymphocyte which can recognize “bad” cells carrying foreign molecular components (antigens) in order to attack and kill them.
Dr. William A. Carter, CEO of Hemispherx, commented on the results as follows. “These results emphasize changes in the blood’s HIV concentration and number of CD8+ cells and reconfirm our data, presented earlier at international meetings in Prague, Barcelona and Naples within the last year, in a larger patient population and with patients longer in the trial. That makes us believe that immune-based therapies may be a potential next step in the treatment of chronic diseases, such as 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, Ampligen and Oragens. These novel proteins and 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) 398-6223
Robert Giordano, MRB Investor Relations
(212) 495-0200, Fax: (212) 495-0746
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 be specifically approved commercially for these other treatment indications.