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Hemispherx Biopharma to Present Audited Results of Ampligen(R) Clinical Trials on Chronic Fatigue Syndrome at 5th International Conference on HHV; Studies Show Medically Significant Improvements Among CFS Patients

Posted on: Wednesday, 3 May 2006, 09:00 CDT

Hemispherx Biopharma, Inc. (AMEX: HEB), will today present the audited results of the Company's experimental therapeutic Ampligen(R) clinical trials in Chronic Fatigue Syndrome at the 5th International Conference on HHV-6&7 in Barcelona, Spain. The presentation shows that the tests achieved improvements far above the levels considered medically significant.

The studies, presented by Dr. William Mitchell Director, Professor at Vanderbilt University and member of the Board with Hemispherx Biopharma, were conducted with Ampligen(R), an experimental double-stranded RNA (dsRNA) with established broad antiviral and immunomodulatory properties that has been studied extensively in the treatment of Chronic Fatigue Syndrome (CFS). A total of five open-labeled and two double-blinded, placebo-controlled trials were done with over 750 subjects.

The primary endpoints for these studies, treadmill performance, clearly demonstrate the results achieved. In the recently completed Phase III trial, patients receiving Ampligen(R) for 40 weeks improved exercise treadmill performance by 14.8% compared to the placebo group, and 12.9% by intent to treat analysis. That's twice the minimum level considered to be medically significant, which is 6.5%.

Ampligen(R) treatment in chronically debilitated CFS populations has demonstrated levels of improvements in both physical well-being and quality of life that can be linked with dysregulation of gene expression associated with energy metabolism. The improvements in exercise duration are significantly correlated to improvements in oxygen utilization and physical performance.

Chronic Fatigue Syndrome has been back in the headlines lately through new research just released by the Centers for Disease Control (CDC). The exhaustive studies presented by the CDC have been described as the most credible scientific evidence yet that a combination of genetics and stress can induce CFS. It was only a few years ago that CFS met with wide skepticism as a condition not only hard to diagnose but perhaps even non-existent. The new research from CDC--conducted by 20 scientists on new genetic and environmental insights--helps pinpoint the genetic predispositions behind this elusive ailment.

Today, CFS is estimated to affect nearly 1 million Americans. The economic impact in the United States, as assessed in a June 2004 study from the CDC, is also severe: The study estimated the total value of annual lost productivity to be $9.1 billion, with $2.3 billion from lost house hold productivity and $6.8 billion from lost labor force productivity. The study did not take into consideration spending on off-label drugs by CFS patients (approximately $8.0 billion) or Social Security benefits extended to CFS patients (approximately $1.5 billion).

Hemispherx Biopharma, which has worked on the front lines of CFS research and treatment for more than a decade, plans to file a new drug application (NDA) for Ampligen(R), which was developed specifically for the potential treatment of CFS, by the end of the year.

The 5th International Conference on HHV is sponsored by the HHV (human herpes virus) 6 Foundation, a non-profit entity formed to foster basic and clinical research into HHV-6 and its diseases. The research of Hemispherx is highlighted under this year's focus on antivirals and immunomodulatory treatments.

About Hemispherx Biopharma

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. Hemispherx Biopharma's flagship products include Alferon(R) and the experimental immunotherapeutics/antivirals Ampligen(R) and Oragens(TM). Alferon(R) is approved for a category of STD infection, and Ampligen(R) and Oragens(TM) represent experimental nucleic acids being developed for globally important viral diseases and disorders of the immune system. Hemispherx's platform technology includes large and small agent components for potential treatment of various chronic viral infections. Hemispherx has in excess of 140 patents comprising its core intellectual property estate, a fully commercialized product (Alferon(R) N) and GMP certified manufacturing facilities for its novel pharma products. For more information please visit www.hemispherx.net

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

Source: Business Wire

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