|March 30, 2005
|Hemispherx Biopharma to Present New Phase III Results in Chronic Fatigue Syndrome Treatment at 18th International Conference on Antiviral Research
|Philadelphia, PA, Wednesday, March 30, 2005: Hemispherx Biopharma (AMX: HEB) has accepted an invitation, from the conference’s committee chairperson to present at the 18th International Conference on Antiviral Research in Barcelona, Spain on April 10, 2005. The presentation will be entitled “Correlation of Increased Oxygen Utilization with Enhanced Treadmill Performance in Patients with Chronic Fatigue Syndrome (CFS) as a Function of AmpligenÒ”. Dr. William Mitchell, MD Ph.D. from Vanderbilt University and a director at Hemispherx, will deliver the oral presentation.
The phase III clinical study, which completed the formal dosing in the fourth quarter of 2004, is the most comprehensive clinical study ever conducted in CFS.
According to recent reports by the Centers for Disease Control and prevention (CDC), CFS, a disease that affects between 400,000 and 800,000 Americans, is more serious than multiple sclerosis in respect to medical severity and overall economic impact on society. This was reported in the CFS Advisory Committee Report dated January 5, 2005.
The phase III clinical trial for AmpligenÒ compares the outcomes of patients on the experimental therapeutic drug AmpligenÒ versus patients on placebo. This trial was conducted over a 64-week observational period. Pooled data from 29 earlier studies of CFS treatment interventions, as reported by the Center for the Advancement of Health, found that people who have the syndrome respond at a lower rate to placebos than patients with other diseases. This finding refutes the commonly held belief that symptoms of CFS are influenced by psychological factors rather than by physiological disturbances.
The phase III clinical trial, which was conducted over five years, involved an enrollment of more than 230 severely debilitated CFS patients and was conducted at twelve medical centers throughout the United States. Physiologists who frequently traveled to each testing site in order to ensure standardized testing measurements and data collection systems carried out the trial.
Hemispherx had originally targeted a late 2004 filing date of its new drug application for AmpligenÒ. In order to comply with the recently expanded regulatory guidelines that place a greater emphasis on the safety and efficacy of all new experimental drug candidates, the company is now incorporating a larger sample of data from its previous trials. The NDA filing will now include data accumulated from 40,000 administrations of studied drug to over 700 CFS patients.
Dr. William A. Carter, CEO of Hemispherx said, “Considerable time and capital have gone into the AmpligenÒ studies on CFS. The peer-reviewed data are very encouraging and we are confident that we may have the first drug that addresses the immense need for a capable treatment for CFS. Hence, it is important, given the recently amended regulatory guidelines, that we provide the regulatory bodies with a more comprehensive NDA filing then we originally anticipated in order to thoroughly demonstrate the long-term safety profile of AmpligenÒ and thereby ensure the greatest possibility of success.”
In parallel, the company is transferring selected components of its overall manufacturing process to its own Good Manufacturing Practice (GMP) facilities in order to improve its own efficiency and compliance procedures, and bringing it in line with worldwide drug manufacturing standards.
Presently, Hemispherx wholly owns a 43,000 sq. foot facility in New Brunswick, New Jersey, which contains the capacity for manufacturing Alferon-N, the only natural interferon product that is commercially available for the treatment of Human Papilloma Virus infection, a disease affecting 20 million Americans according to National Institutes of Health statistics.
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® and the experimental antiviral products, Ampligen® 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®) and GMP certified manufacturing facilities for its novel pharma products. For more information please visit www.hemispherx.net .
Hemispherx Biopharma, Inc.,
Dianne Will, Investor Relations
(518) 398-6222, Fax: (518) 398-6369
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 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 and Oragens) 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®, and this determination can only be legally made by regulatory bodies. Clinical trials for other potential indications of the approved biologic Alferon N do not imply that the product will ever be specifically approved commercially for these other treatment indications including avian flu.