| May 13, 2003 |
| Hemispherx Initiates Collaboration on SARS with Genome Institute of Singapore |
Company launches efforts to combat SARS with its lead Products Ampligen® and Alferon® N
Philadelphia, PA, Tuesday, May 13, 2003: Hemispherx Biopharma, Inc. (AMEX: HEB) announced today that, in response to an urgent request from the Singapore Government, it is initiating a research collaboration on SARS with its Alferon® N Product, which already has received a full commercial license in Singapore, and Ampligen®, a double stranded RNA experimental drug, which is also active in coronaviruses (SARS is a human coronavirus).
Collaborative Partner’s Accomplishments
The collaboration partner will be the Genome Institute of Singapore (GIS). GIS is a Government funded research institute under Agency for Science, Technology and Research (A-Star), which is Singapore’s equivalent of the National Science Foundation and National Institutes of Health in the United States of America. The GIS is one of the very few research institutes globally that successfully sequenced the SARS virus’ genome, as just published in Lancet Volume 361, Number 9369, 2003.
About SARS
According to the CDC, severe acute respiratory syndrome (SARS) is a respiratory illness that has recently been reported in Asia, North America and Europe. Scientists at CDC and other laboratories have detected a previously unrecognized coronavirus in patients with SARS. It is more than seven weeks now since the illness spread from its birthplace in southern China to put the world on alert. Yet with more than 7296 cases, 526 deaths in 28 countries, plus 63 probable cases in the U.S., the disease has especially rocked the Asian markets. Death rates overall are 15% and exceed 50% in elderly patients.
Animal Models Evaluating Alferon in SARS
The human SARS is now believed to be due to a bird or pig coronavirus, which “jumped” from one animal species to another. Multiple viral mutations are occurring due to the ‘trans-species” movement of the virus. An independent study, in a pig population of close to 2000 animals in Texas, living under typical field/farm conditions, has been conducted in animals treated with Alferon®, in low doses, and compared with placebo in terms of survival rates. These piglet coronavirus studies will be described shortly. Comprehensive animal studies are not necessarily indicative of benefit, or lack thereof, in humans, which require independent investigation to evaluate safety and efficacy.
Alferon® Potency
Alferon®, which is composed of eight forms of high purified alpha interferon (derived from human white blood cells) has been demonstrated in laboratory studies to be up to 100 times more potent than recombinant (bacterially derived) interferons (rIFNs). In contrast, rIFN consist of only one molecular form of IFN and lacks the necessary sugars or carbohydrates necessary to avoid human antibody formation. Antibody formation can destroy the clinical benefit of IFN. SARS should be considered a potential indication for Alferon®, which is at an experimental stage of development for this disorder and which has a commercial approval in Singapore and other areas of Asia for a specific STD category, including refractory lesions caused by HPV virus.
Ampligen® and U.S. Government Sponsored ongoing Studies with SARS
Ampligen® is a experimental, double stranded RNA drug acting potentially as an immunomodulator and antiviral. Based on in vitro studies, Ampligen® is believed to stimulate the immune system as well as destroy viruses directly. The product is currently in Phase 3 clinical trials for the potential treatment of Chronic Fatigue Syndrome (CFS) and in two Phase 2b clinical trials for the potential treatment of HIV/AIDS. SARS, which is believed to be a coronavirus and the HIV virus both belong to the group of ribose nucleic acid (RNA) viruses which frequently change and mutate, though the coronavirus is less complex than the HIV virus. The Company and the U.S. Government sponsored researchers are currently evaluating the Company’s RNA drug platform as a potential treatment against human SARS. Results are expected to be announced shortly.
The Company is taking all appropriate steps to enlarge its patent estate with respect to its Alferon® and Ampligen® technology for the potential treatment of human coronaviruses including SARS. The two drugs are also believed to operate synergistically in certain laboratory tests.
About Hemispherx
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.
Contact(s):
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 Alferon® do not imply that the product will be specifically approved commercially for these other treatment indications. 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.
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