|July 15, 2003
|HEMISPHERX REPORTS NEW HIV TREATMENT DATA ON AMPLIGEN AT THE 2nd IAS CONFERENCE ON HIV PATHOGENESIS AND TREATMENT
|Initial Therapeutic Data on Immune Response Now Confirmed over Significantly Longer Observation Period
Philadelphia, PA, Tuesday, July 15, 2003: Hemispherx Biopharma, Inc. (AMEX: HEB) announced today that at the 2nd IAS Conference on HIV Pathogenesis and Treatment in Paris, France, most recent data of its Phase IIb clinical trial, AMP 720, was reported. Using Strategic Treatment Interruption (STI), patients’ antiviral HAART regimens are interrupted and Ampligen® is substituted as mono-immunotherapy. Ampligen® is an experimental immunotherapeutic designed to display both antiviral and immune enhancing characteristics.
About the Conference
The 2nd IAS Conference on HIV Pathogenesis and Treatment (www.ias2003.org) is held in Paris, France, July 13-17. The International AIDS Society (IAS) is the world’s professional society representing clinicians and public health experts engaged in HIV/AIDS research, prevention, care and treatment. The IAS has more than 10,000 members representing more than 130 countries, backed by affiliated regional and national HIV/AIDS societies. The Conference is organized in scientific collaboration with National Institutes of Health (NIH) and Center of Disease Control and Prevention (CDC).
Toxicity of HAART
Prolonged use of Highly Active Antiretroviral Therapy (HAART) has been associated with long-term, potentially fatal, toxicities. The clinical study AMP 720 is designed to address these issues by evaluating the administration of the Company’s lead experimental agent, Ampligen®, a double stranded RNA drug acting potentially both as an immunomodulator and antiviral.
Patients, who have completed at least 9 months of Ampligen® therapy, were able to stay off HAART for a total STI duration with a mean time of 29.0 weeks (and continuing), whereas the control group, which was also taken off HAART, but not given Ampligen®, had earlier HIV rebound with a mean duration of 18.7 weeks (p = 0.05). Thus, on average, Ampligen® therapy spared the patients excessive exposure to HAART, with its inherent toxicities, for more than 11 weeks.
The HAART regimen combines multiple drugs that directly attack the HIV virus, often leading to virus mutation and drug resistance. In contrast, the Ampligen® therapy has been generally well tolerated in the HIV population with no evidence to date of any increase in toxicities commonly seen with the existing HAART regimens.
These present results substantially enlarge the data, presented earlier at different international conferences, including the DART Conference in late 2002, by providing clinical observation over a much longer treatment period.
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) 398-6223
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.