Hemispherx Biopharma to Report New Data on Pivotal Phase III Study in CFS; Company Expands Pivotal Study Results at Upcoming 44th ICAAC Meeting (44th Interscience Conference on Antimicrobial Agents and Chemotherapy)

Business Wire - August 2, 2004

PHILADELPHIA -- Hemispherx Biopharma, Inc. announced today that an abstract entitled "Chronic Fatigue Syndrome (CFS): Phase III, Randomized, Double-Blinded Clinical Trial Shows Significant Improvement in the Primary Endpoint, Exercise Treadmill Duration, with Ampligen" has been accepted by the 44th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). ICAAC, sponsored by the American Society of Microbiology, is one of the largest and most prestigious infectious disease meetings in the world. The 44th annual conference will be held in October 2004 in Washington, DC.

About Chronic Fatigue Syndrome

CFS is defined by various governmental agencies worldwide as a serious debilitating disease in which patients suffer from complex symptoms, including primarily disabling fatigue, associated with chronic flu like symptoms, which profoundly impaired physical performance. The CDC has added CFS to its top priority list of emerging infectious diseases. CFS is a worldwide disease estimated to affect over 500,000 people in the U.S. and similar number in Europe and the Far East, including Japan.

About Ampligen(R)

Ampligen is an experimental, double stranded RNA drug acting potentially as an immunomodulator and antiviral. Based on in vitro studies, Ampligen is believed to modulate the immune system as well as inhibit viruses directly. The experimental product is in Phase III testing for the potential treatment of CFS and in two Phase IIb clinical trials for the potential treatment of HIV/AIDS. The FDA has already authorized Ampligen Emergency Treatment/Cost Recovery IND Status and Orphan Drug Status. Treatment status was authorized after an earlier reported study of 24 weeks duration consisting of 92 patients with severe CFS randomized to receive either Ampligen or Placebo. Only governmental regulatory agencies can make a definitive determination that the presumed efficacy/safety ratio of any new drug supports its potential commercial introduction for any disorder, including potential CFS treatment.

At ICAAC, new data on the pivotal CFS trial (234 patients) will include physiological measurements of oxygen consumption as well as quantitative measurements of physical performance capacity when patients are provided either Ampligen or placebo for 40 consecutive weeks under well-controlled conditions.

About Hemispherx

Hemispherx Biopharma, based in Philadelphia, is an advanced-stage biopharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of various 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 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(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, Inc.

Investor Relations:

Dianne Will, 518-398-6222

ir@hemispherx.net

www.hemispherx.net

CEOcast

Kevin Theiss, 212-732-4300

ktheiss@ceocast.com

SOURCE: Hemispherx Biopharma, Inc.

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