|May 10, 2004
|HEMISPHERX BIOPHARMA LAUNCHES NEW HIV CLINICAL PROGRAM IN AFRICA WITH COST EFFECTIVE ANTIVIRAL DELIVERY
| Key Collaboration with the World Foundation Aids Research and Prevention
Philadelphia, PA, Monday, May 10, 2004: Hemispherx Biopharma, Inc. (AMEX: HEB) announced today that it entered into an agreement with the World Foundation Aids Research and Prevention to launch a clinical trial in HIV with its experimental product Alferon LDO®, a low dose oral, fully natural, alpha interferon cocktail.
The study will be performed at the Centre Integré de Recherches Biocliniques d’Abidjan (CIRBA), an internationally accredited center of clinical and immuno-virologic research for the study of HIV infection in Ivory Coast. The Center is recognized as a leading venue for treating HIV, possessing the latest biotech capabilities in both virologic and immunologic research. The Center is intended to serve as a treatment and research model for the entire African continent. Currently, in the Clinical Center, launched in 1998, more than 400 HIV+ patients are being followed.
This well controlled trial will determine the effect on virus load and immune system of Alferon LDO® in a protocol of treatment of naïve, early stage, African patients. Specifically, the main endpoints of the study will be measurements of viral load and CD4 numbers. Forty asymptomatic HIV+ patients, naïve to antiretroviral therapy, will be selected. Twenty will receive placebo and twenty will be treated with Alferon LDO®, orally dosed every other day for a period of 6 months. The trial is expected to initiate during this quarter. Hemispherx believes, due to its low cost of delivery, that Alferon LDO® could be particularly effective in developing countries, where AIDS has reached epidemic proportions.
The World Foundation Aids Research and Prevention will take responsibility for the coordination of the trial, including patient accrual and clinical investigators. Professor Montagnier, President of the Foundation, actively campaigns on a global scale for new treatment efforts and his recommendations are widely covered by the AIDS community, the world press and government agencies. On May 1st, 2004, Dr. Luc Montagnier and Dr. Robert Gallo were inducted into the National Inventors Hall of Fame for their invention of HIV Isolation and Diagnosis. The National Inventors Hall of Fame Museum recognizes the lives and accomplishments of its inductees, which include the world’s most influential inventors. After Dr. Louis Pasteur, Professor Montagnier is the second Frenchman ever to have received such an honor.
About Professor Luc Montagnier
Professor Montagnier has been an active researcher in oncology and virology for almost four decades. Throughout the 1970’s and 1980’s he focused on RNA tumor viruses and did extensive work on interferon in both animal and human systems. In 1983, as head of the Viral Oncology Unit at the Pasteur Institute in Paris, he and his colleagues discovered the human retrovirus, which later became known as HIV-1, the etiologic agent of AIDS. In 1985, his team isolated the second human AIDS virus, HIV-2. Since then, he has coordinated the work of a distinguished group of collaborators on the mechanism of AIDS pathogenesis.
About Alferon LDO®
Alferon LDO®, the first low dose oral, fully natural, alpha human interferon experimental cocktail, derived from an approved parenteral interferon form, is believed to work by stimulating an immune cascade response in the cells of the mouth and throat, enabling it to bolster an immune response through the entire body orally. Oral interferon biological activity has been shown at less than 0.1% of the doses administered through the traditional injection routs. Oral interferon administration would potentially be much more economically feasible for patients, including those in developing nations with limited access to a medical infrastructure. Alferon LDO®, an experimental immunotherapeutic, with its affordability, ease of use, favorable side-effect profile, no production of antibodies, and broad range of potential activity, thus is a prime candidate for potential treatment of various dreaded disorders in third world countries.
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® 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) 398-6369
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. 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 AlferonÒ do not imply that the product will ever be specifically approved commercially for these other treatment indication.