Monday, January 03, 2005

Clinical trial with Ampligen

The following is a copy of a report on Ampligen, filed here for future reference incase Ampligen proves to represent a breakthrough for ME/CFS sufferers.

Esteve was granted the exclusive right to market Ampligen(R) in Spain, Portugal and Andorra for the treatment of Chronic Fatigue Syndrome (CFS).

Hemispherx Biopharma Initiates Enrollment in HIV/HEP-C Clinical Program; Clinical Trial with Ampligen in Collaboration with Esteve Laboratorios Targets HIV/HEP-C Twin Epidemics

PHILADELPHIA--(BUSINESS WIRE)--Jan 3, 2005 - Hemispherx Biopharma, Inc. (AMEX: HEB) announced today that its partner Esteve Laboratorios, Spain, initiated a clinical program to evaluate the antiretroviral effect of Ampligen in the treatment of patients infected by HIV-1 (with or without co-infection by HCV) and virological failure with a randomized pilot study in Phase II, controlled with standard treatment.

In March 2002, Hemispherx S.A., a subsidiary of Hemispherx Biopharma, entered into a Sales and Distribution Agreement with Esteve. Pursuant to the terms of the Agreement, Esteve was granted the exclusive right to market Ampligen(R) in Spain, Portugal and Andorra for the treatment of Chronic Fatigue Syndrome (CFS). In addition to other terms and other projected payments, Esteve agreed to conduct, at its expense, certain clinical trials using Ampligen(R) in the patient population co-infected with Hepatitis C and HIV viruses.

At present, no single drug or biological product has been deemed by internationally recognized regulatory agencies as effective against both viruses, when coexisting in the same patients.

About HIV/Hep-C Co-Infection

About 40% of people living with HIV are co-infected with HCV, with disproportional high co-infection rates among intravenous drug users. Both HIV and HCV are chronic viral illnesses, and there are similarities in the mechanisms of viral reproduction (also known as replication) and acute infection. Both HIV and HCV replicate in the body at an incredibly fast rate. Data gathered from 4,000 HIV-infected individuals indicates that liver failure due to HCV is the leading non-AIDS cause of death in people with HIV. Additionally, studies have shown that HIV worsens HCV infection. Individuals co-infected with HIV and HCV are about twenty times as likely to experience liver failure as individuals infected with HCV alone. Just as HIV mutates, resulting in drug-resistant strains, HCV can also mutate. If HCV is under pressure from medications that block replication, it will mutate at increased rates.

About Esteve Laboratorios

Esteve is one of the largest pharmaceutical-chemical corporations in Southern Europe, with an international presence through subsidiaries in Italy and Portugal and worldwide licenses and distributors. Since 1960, Esteve has established strategic alliances with multinational pharmaceutical chemical companies to develop and market their products in Europe. Esteve has established its own successful research and development capabilities, developing new chemical entities and manufacturing active pharmaceutical ingredients with its research products marketed in over 90 countries.

More information about Esteve is available at

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 N(R) and the experimental immunotherapeutics/antivirals Ampligen(R) and Oragens(TM). 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 270 patents comprising its core intellectual property estate, a fully commercialized product (Alferon N(R)) and GMP certified manufacturing facilities for its novel pharma products. For more information please visit

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 Ampligen(R) and Oragens(TM)) 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 Alferon(R) do not imply that the product will ever be specifically approved commercially for these other treatment indication.

Contact Hemispherx Biopharma Investor Relations: Dianne Will, 518-398-6222 or Investor Relations Group John Nesbett / Erik Lux 212-825-3210

Further reading:

Sep. 28, 2004: Hemispherx Biopharma to Present New Data on Activity of Ampligen in Treating Chronic Fatigue Syndrome at Annual CFS Conference

Oct 16, 2004: Ampligen Data Presented at the 7th International Conference for Chronic Fatigue Syndrome


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