PHILADELPHIA–(BUSINESS WIRE)–Nov. 15, 2004-
-Hemispherx Biopharma, Inc. (Amex:HEB) announced that the Department of Health and Human Services CFS Advisory Committee recently held its fifth meeting in Washington, D.C. Representatives from the Social Security Administration, the Food and Drug Administration and Health Resources and Services Administration were on hand to answer questions about Chronic Fatigue Syndrome (CFS) and the issues surrounding treatment and for the purposes of educating the public about the disease.
During this session, Utah clinician Dr. Lucinda Bateman made a presentation on behalf of her patients, who are enrolled in a double-blind study of Ampligen, a drug produced and sold by Hemispherx. Dr. Bateman believes that Ampligen offers substantial clinical benefit to "carefully selected patients." She reported that several of the patients at her site were able to return to more active lives and that there were relatively few side effects in her group. Dr. Bateman urged the FDA to approve the drug. Mary Schweitzer, Ph.D., echoed Dr. Bateman's support for approval of Ampligen, a drug that she has been able to benefit from through special cost recovery provisions that allow her to purchase the drug although it has not yet been approved for marketing.
Several of the speakers offered their appreciation for the committee's efforts and the dedication to important issues that committee members have demonstrated in their first year of work. Ampligen is an experimental, specifically configured, double-stranded RNA drug. The experimental product has completed a phase 3 clinical trial for the potential treatment of CFS. 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 94 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. Its flagship products include Alferon N(R) and the experimental antivirals 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 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 including SARS. The Alferon(R) asset for overseas sales for a category of STD is currently being acquired by the Company as part of a multi-step purchase contract of inventory, intellectual property, commercial licenses and GMP approved facilities, which house the biological operations.