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New Government Sponsored Research Points to Gene Malfunction in Chronic Fatigue Syndrome (CFS)

Posted on: Wednesday, 6 July 2005, 09:00 CDT

Exercise Induced Malfunction in Genes Provides New Potential Insight into Mechanism of Ampligen(R) Phase III Clinicals; Exercise Treadmill Improvement as Primary Efficacy Endpoint

Hemispherx Biopharma, Inc. (Amex:HEB) announces that newly published independent studies from Center for Disease Control (CDC) researchers provide molecular evidence on the central role of exercise intolerance in the morbidity of patients suffering from CFS. Although CFS is associated according to CDC criteria with some 12 other debilitating clinical manifestations (fever, myalgia, etc.), the overarching primary symptom is profound exertional fatigue which undermines the quality of life. Following on its recent tradition of intense investigation into medical and economic sequelae of CFS, the CDC now reports ("Exercise responsive genes measured in peripheral blood of women with CFS and matched control subjects", BioMedCentral.com/1472-6793/5/5) that a pool of metabolism (energy) genes, whose function may be associated with bodily functions such as muscle contraction and oxygen consumption, are impaired in women with CFS on exercise challenge. A matched cohort of sedentary healthy women did not exhibit a similar pattern of gene malfunction. Other exercise induced gene abnormalities were also noted, apparently involving the immune system.

Gene abnormalities, such as those described by the CDC researchers, might be the result of inherited weakness in energy transfer/metabolism, or - in the alternative - the gene weakness might be caused by various environmental factors such as exogenous viruses and/or noxious agents such as chemical toxins. Further clinical and molecular research will be needed to distinguish between these various etiological possibilities.

Exercise treadmill impairment is already a recognized "end point" to quantify disability in various chronic diseases, particularly including CFS. Thus, the US Social Security Administration (SSA) has implemented a policy of recognizing the functional impairment on treadmill performance as the basis for partial or complete disability - thereby qualifying CFS sufferers for long-term governmental subsidies (partial, or complete financial support). The average age of onset of CFS is about 35, coinciding with the peak of professional achievement and income potential.

Accordingly, Hemispherx adopted the exercise treadmill testing as the primary therapeutic (efficacy) endpoint in its recently completed Phase III Study (active drug vs. placebo in a one-to-one randomization) of 234 patients evaluated for 64 weeks. By predetermined regulatory/scientific criteria, the drug arm evidenced certain medically and statistically significant changes over the placebo arm. These clinical effects were recently summarized at the peer reviewed XVIII International Congress in Barcelona, Spain. Separate investigations have indicated that double-stranded RNA drug molecules (of which Ampligen(R) is an example) may activate a battery of human genes. Thus it appears that the physical performance changes observed on treadmill testing might be due in part to changes at the gene level. While gene modulation studies were conducted apart from the recently completed Phase III studies (which relied on clinical endpoints) parallel in vitro studies on interferon inducers (such as double-stranded RNAs) have suggested a possible role in modulating gene activity associated with energy transport and metabolism.

About Hemispherx

Hemispherx Biopharma, based in Philadelphia, is a biopharmaceutical company engaged in the manufacture and clinical development of new drug entities. Hemispherx's flagship products include Alferon N(R) and the experimental antiviral products, Ampligen(R) and Oragens(TM). These novel Alferon-N proteins, commercially available for a category of STD infection, and experimental nucleic acids are being developed for globally important chronic diseases and disorders of the immune system including HPV, HIV, CFS and hepatitis and avian flu. Its four major technology platforms include large-and small-agent components for potential treatment of various chronic viral infections, and are being developed with various corporate, governmental and academic collaborators worldwide. Hemispherx has in excess of 150 patents comprising its core intellectual property estate, a fully commercialized product (Alferon N(R)) and GMP certified manufacturing facilities for its novel pharma products. Presently it is expanding its facilities to accommodate GMP production of Ampligen(R). For more information please visit 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) 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. 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 N do not imply that the product will ever be specifically approved commercially for these other potential treatment indications.

Source: Business Wire

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