NEW YORK –(Business Wire)– May 3, 2005 — Chronic Fatigue Syndrome (CFS) diagnosis and current potential medical management for the debilitating disease were highlighted at a scientific symposium held recently in New York City. The conference, sponsored by Hemispherx Biopharma (AMEX:HEB), included presentations by CFS experts Dr. Richard N. Podell, a graduate of Harvard Medical School and presently affiliated with Robert Wood Johnson Medical School and Dr. Lucinda Bateman from Johns Hopkins University. Dr. Bateman, who directs the Fatigue Consultation Clinic in Salt Lake City, Utah, presented a comprehensive introduction and overview of CFS, giving the medical community an opportunity to get a better sense of the magnitude of the disease both in terms of individual suffering and economic costs.
Dr. Podell summarized the investigational therapeutic Ampligen(R) Phase III results for which he was a Principal Investigator. Dr. Podell also participated in earlier evaluations of the investigational and experimental treatment of CFS. Both physicians received consultative fees from the Company for conducting the clinical investigations and reporting results at peer reviewed scientific meetings.
CFS is a debilitating disease that affects between 400,000 and 1,000,000 Americans and an equal number of Europeans. There is currently no effective treatment available in the marketplace. CFS imparts profound deficits in oxygen consumption on its sufferers, which impairs their ability to perform functions necessary to maintain a basic quality of life. According to a report by the Centers for Disease Control and Prevention (CDC), CFS is more serious than multiple sclerosis with respect to medical severity and the overall economic affect that it has on society. This was reported in the CFS Advisory Committee Report dated January 5, 2005. Health professional interested in learning more about Hemispherx’ investigational and research programs in CFS and allied disorders may contact the Company at IR@Hemispherx.net.
For several years, Hemispherx has co-sponsored various scientific meetings in CFS and provided research grants/contracts to better understand the disorder. Other sources of information on the disorder may be accessed at: the Center for Disease Control and Prevention (http://www.cdc.gov.ncidod/diseases/cfs/), the National Institute of Health (http://www.niaid.nih.gov/factsheets/cfs.htm), The Chronic Fatigue Syndrome Advisory Committee (http://www.cfids.org/cfidslink/oct-cfsac-update.asp?view=print).
Hemispherx Biopharma, based in Philadelphia, is a biopharmaceutical company engaged in the manufacture and clinical development of new drug entities. Its 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. 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 more than 200 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
The Company’s work in the development of Ampligen(R), following its initial licensure from Johns Hopkins University, has spanned about 1.5 decades. For clarification and amplification of previous Company press releases regarding this extensive development work, early in the process, after the Company concluded an FDA approved well controlled 24 week study of 92 patients with CFS, the FDA, in 1991, placed Ampligen(R) on clinical “hold” because of questions and concerns regarding various potential toxicities, including life-threatening events. Subsequently, following several years of extensive data analysis and further lab tests on selected CFS patients, the FDA, on May 1, 1997, approved the Company’s treatment protocol, Amp 511, under its Investigational New Drug #39,250 utilizing Ampligen(R) in the treatment of patients with severe CFS, and on March 10, 1998 provided written authorization for the Company’s pivotal Phase III, double blind study, Amp 516, utilizing Ampligen(R) in the 64 week treatment of 234 patients with CFS. To date, with more than 750 CFS patients having been treated with study medication (either Ampligen(R) or placebo), no statistical analysis conducted by the Company and/or its independent statistical consultants has revealed a statistically-significant difference in serious adverse events between the two arms of study medication (Ampligen(R) vs. placebo). It should be noted, however, that only regulatory bodies, including the FDA, are allowed to make the determination of drug safety; further, the completion of a Phase III study should not be construed as predicting when, if ever, any drug, including Ampligen(R), would be approved for any commercial sales. For further information on the process of conduct of clinical trials and the steps of regulatory review, please read the relevant sections of the Company’s filings with the Securities and Exchange Commission.
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 including Ampligen(R), and this determination can only be legally made by regulatory bodies. Clinical trials for other potential indications of the approved biologic Alferon N(R) do not imply that the product will ever be specifically approved commercially for these other treatment indications.