|December 04, 2001
|Hemispherx Comments on New Report From U.S. Agency for Healthcare Research and Quality -- AHRQ -- on Chronic Fatique Syndrome -- CFS --
| CFS Is Recognized, Defined, and Number of Sufferers Are Estimated
Phase III Level Ampligen® Yielded the Most Promising Results of All Therapies Surveyed
Philadelphia, PA, Tuesday, December 04, 2001: Hemispherx Biopharma, Inc. (AMEX: HEB), a leading company in the development of immune based therapies primarily addressing the diseases of Chronic Fatigue Syndrome and HIV AIDS commented today that a recent report of the United States Agency for Healthcare Research and Quality (AHRQ) confirmed the existence of, and further defined the disease Chronic Fatigue Syndrome and indicated that ``of all the therapies surveyed, Ampligen® yielded the most promising results.''
The National Institute of Allergy and Infectious Diseases nominated the topic for an evidence based review and the Agency for Healthcare Research and Quality contracted with the San Antonio Evidence-based Practice Center(EPC) for the study.
In commenting on the existence and definition of the disease the study indicated, ``There are four well-recognized case definitions of CFS ... A few comparative research studies support the concept of a condition characterized by prolonged fatigue and impaired ability to function, which is captured by the case definitions.''
The study estimated the number of U.S. sufferers at less than 1 percent of the population, further refining the estimate to a range on the low side of .04 percent to a high side range of 2.6 percent. This would indicate a range of sufferers from between one million on the low side to approximately 7 million on the high side.
The immunologic therapies that were assessed included agents such as immunoglobulin, Ampligen®, Acyclovir, Interferon, and transfer factor. The performance of Ampligen® was rated as follows, ``A single randomized placebo-controlled trial found twice weekly infusions of intravenous Ampligen®, an agent with immunomodulatory and antiviral effects, improved physical functioning, activity level, and cognitive functioning and did not affect depression or anxiety. This high-quality double-blind trial included 92 severely debilitated patients who met the 1988 C. D.C. definition for CFS. It had a six month follow-up, and 9 percent dropout rate.''
In summarizing the performance of Ampligen®, as compared to the other immunologically based agents that were surveyed, the report concluded, ``Ampligen®, an investigational drug that is not approved by the Food and Drug Administration, given intravenous to severely debilitated patients yielded the most promising results.''
Dr. William Carter, the Chief Executive Officer of Hemispherx commented on the report as follows, ``This report confirms the overall position we have taken regarding the existence of this disease, the number of Americans who suffer from it, the seriousness of its impact on people who have the disease, and the potential efficacy of our lead drug Ampligen®, which is the only investigational therapy being developed at the Phase III level.''
Hemispherx Biopharma, based in Philadelphia, is a pharmaceutical company engaged in the manufacture and global clinical development of new drug entities in the nucleic acid (NA) class for chronic viral diseases and disorders of the immune system including CFS, HIV and hepatitis. Its flagship products are Ampligen® -- being developed for CFS and drug resistant HIV -- and Polyandenur being developed for hepatitis B and C. It is conducting phase III trials in CFS and phase IIb trials in HIV/AIDS. For more information visit the company's Web site at www.hemispherx.net
William A. Carter, M.D., CEO & Chairman, Hemispherx Biopharma, Inc. (215) 988-0080
Dianne Will, Investor Relations, (518) 398-6222, Fax: (518) 398-6223
Robert Giordano, Institutional Investors, KCSA, (212) 230-1727, Fax: (212) 230-1734
HEB's Web Site: 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 risks of competition, changing market conditions, changes 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. Accordingly, actual results including financial results may differ materially from those in any forward-looking statements. Additionally, all the referenced investigational drugs and associated technologies of the company 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.