PHILADELPHIA–(BUSINESS WIRE)–Sept. 27, 2004– Compares Activity of Ampligen(R) to Alzheimer Drug for Potential Treatment
Hemispherx Biopharma, Inc. (AMEX:HEB), a leading developer of immune based therapies to treat Chronic Fatigue Syndrome (CFS) and HIV/AIDS, announced today that it will present new data on controlled testing of Ampligen(R) at the upcoming International CFS meeting in Madison, Wisconsin on October 9, 2004. Hemispherx's drug, Ampligen(R), an experimental immunotherapeutic, demonstrated medically and statistically significant increase in the primary endpoint, exercise treadmill duration, compared to placebo after a 40 week period. The Company, at the Conference, will present additional data on its clinical activities.
A number of drugs have been tested, and reported upon, in the treatment of CFS. In the current issue of JAMA, Dr. C. V. Russell Blacker from Exeter, UK and colleagues assessed the outcome of 434 CFS patients who were treated with one of four doses of Reminyl, which is manufactured by Shire Phamaceuticals or with an inactive "placebo". After 16 weeks of treatment, there were no statistically significant differences between any Reminyl or placebo groups in clinical condition on the primary end point, Clinician Global Impression Scale, or for any of the secondary end points. Exploratory regression analysis failed to detect any consistent prognostic factor that might have influenced the primary or secondary outcome measures, as reported in the September 8, 2004 Journal of the American Medical Association. "We remain encouraged that our protocol is the only one that addresses the large unmet medical need of patients with CFS," said William Carter, M.D. "We look forward to initiating steps designed to bring this product to market as rapidly as possible."
About Chronic Fatigue Syndrome CFS is defined by various governmental agencies worldwide as a serious debilitating disease in which patients suffer from complex symptoms, primary profound fatigue which severely limits daily activities. 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 a similar number in Europe and Asia.
About Ampligen(R) Ampligen(R) 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 currently in a Phase III clinical trial for the potential treatment of Chronic Fatigue Syndrome (CFS) and in two Phase IIb clinical trials for the potential treatment of HIV/AIDS. The FDA has already granted Ampligen Treatment IND Status and Orphan Drug Status. Treatment IND status was granted 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 commercial introduction for any disorder, including potential CFS treatment.
About Hemispherx 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 over 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
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.