Hemispherx Biopharma to Present First Phase 3 Data on Ampligen in Chronic Fatigue Syndrome at the 17th International Conference on Antiviral Research
International Conference on Antiviral Research
PHILADELPHIA–(BUSINESS WIRE)–April 13, 2004– Primary Endpoint Data Presented at International Conference to be Held May 2-6, 2004
Hemispherx Biopharma, Inc. (AMEX: HEB) announced today that the Executive Committee of the 17th International Conference on Antiviral Research, to be held in Tucson, Arizona, has accepted the Company’s late breaker abstract, assigned number “LB-5”, and scheduled in Oral Session VII on Thursday, May 6, 2004 at 3:45 p.m.
Professor William M. Mitchell, Professor at Vanderbilt University, Department of Pathology, will conduct the presentation. The abstract will disclose the first results obtained from the Company’s phase 3 clinical trial in Chronic Fatigue Syndrome (CFS) with its experimental immunomodulator Ampligen(R), examining the primary efficacy endpoint, physical performance, as determined by treadmill duration.
About the 17th International Conference on Antiviral Research
The purpose of the International Conference on Antiviral Research is to provide an interdisciplinary forum at which investigators involved in basic, applied, and clinical research worldwide can meet to review recent developments in all areas of antiviral research. Specific topics to be covered in the program include synthesis and chemistry, biochemistry and mechanism of action, molecular biology and drug targeting, in vitro evaluation, animal models, pharmacokinetics, toxicology, and clinical trials. Within these areas of interest, there will be invited overview speakers, oral presentations, and poster presentations. The 17th International Conference on Antiviral Research will be held in Tucson, Arizona, USA. All scientific sessions will be held at the Hilton El Conquistador Hotel.
About Chronic Fatigue Syndrome
CFS is well defined by various governmental agencies as a serious debilitating disease in which patients suffer from multiple symptoms, including profoundly disabling fatigue with chronic flu-like symptoms. The U.S. Center for Disease Control and Prevention (CDC) has added CFS to its top priority list of emerging infectious diseases. CFS is estimated to affect over 500,000 people in the U.S., and an equal number in Europe.
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 the virus directly. The experimental product is currently in a phase 3 clinical trial for the potential treatment of CFS and in two Phase 2b clinical trials for the potential treatment of HIV/AIDS. The FDA has granted Ampligen Treatment IND Status and Orphan Drug Status.
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 400 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 indications.
Hemispherx Biopharma, Inc.
Dianne Will, 518-398-6222
Cormac Glynn, 212-732-4300