Hemispherx Receives FDA Approval To Expand CFS Program

/ Number of Patients More Than Double in Cost-Recovery Treatment Philadelphia (PROTEXT) - Hemispherx Biopharma, Inc. (Amex:HEB) today said that it has received authorization from the Foodand Drug Administration (FDA) to more than double the number ofpatients undergoing treatment in its cost-recovery program forChronic Fatigue Syndrome (CFS). In the first quarter, Hemipsherx announced that activetreatment of patients in a confirmatory Phase III clinical trialof its drug Ampligen(R) was underway in a 40-week protocol thatinvolved placebo-controlled, double- blind testing. Today's announcement concerns the parallel clinical activityin the U.S. in which now more than 100 patients suffering fromseverely debilitating CFS will pay for Ampligen(R) to be usedduring the clinical program. The Company said that a key part ofits drug development strategy has been to use various incentivesthat the FDA has made available to Hemispherx, including thiscost recovery program. With the new FDA authorization, it is estimated that more than200 patients with CFS, which is also known as MylagicEncephalomyelitis (ME) in Europe, are involved in the combinedprograms. Patients are currently being evaluated in San Diego;Los Angeles/Irvine, California; San Francisco Bay/InclineVillage, Nevada; Tulsa, Oklahoma; Miami/Hollywood, Florida;Chicago; Salt Lake City; Charlotte, North Carolina;Philadelphia/Delaware Valley region, Pennsylvania; Montgomery,Alabama; Washington, D.C.; New York City and three sites in theNew York City/Long Island/Northern New Jersey area. These sitesrepresent the top CFS/ME investigators in the U.S. Hemispherx,which is based in Philadelphia, also has offices in Brussels,Belgium, and antiviral drug development facilities in Rockville,Maryland. At the end of last year, Hemispherx Biopharma Europe, asubsidiary company, filed a full marketing application inBrussels and London that covers the 15-country membership in theEuropean Union. The Company also has said that additionalapplications for full marketing approval in other countries areexpected, based on clinical results to date. Patients not eligible for the Phase III confirmatory trial inthe U.S. may seek treatment under the expanded treatment protocoladministered by the Hemispherx and Olsten Health Services, asubsidiary of Olsten Corporation. Timely information can beobtained on a Hot Line at 888-559-4623, managed by Olsten HealthCare. To the Company's knowledge, Hemishperx is the only companywith authorized Phase III studies in the U.S. for CFS and theonly company with a pending application for full marketingapproval in any major pharmaceutical market world-wide. TheCenters for Disease Control estimates that CFS affectsapproximately 500,000 Americans and various medical studiessuggest a similar number of Europeans are affected as well. Hemispherx Biopharma, which is based in Philadelphia, is apharmaceutical company engaged in the manufacture and globalclinical development of new drug entities in the nucleic acid(NA) class for chronic viral diseases and disorders of the immunesystem including CFS, hepatitis B and hepatitis C. Information contained in this news release, other thanhistorical information, should be considered forward-looking andis subject to various risk factors and uncertainties. Forinstance, the strategies and operations of Hemispherx involverisks of competition, changing market conditions, changes in lawsand regulations affecting these industries and numerous otherfactors discussed in this release and in the Company's filingswith the Securities and Exchange Commission. Accordingly, actualresults may differ materially from those in any forward-lookingstatements. ots Original Text Service: Hemispherx Biopharma,Inc. Internet: http://www.newsaktuell.de Contact: William A.Carter, M.D. CEO and Chairman of Hemispherx Biopharma, Inc. (USA)215-988-0080; or Media - William J. Jenks (USA) 212-232-2222,fax, (USA) 212-232-3232, or Investor Relations - Sharon Will(USA) 212-572-0762, fax, 212-572-0764 Web site:http://www.hemispherx.com

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