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| |  New Chronic Fatigue Drug Available in U.S. and Canada PHILADELPHIA, June 26, 1997 -- Five clinical sites across the United States have received approval to participate in the FDA-approved Ampligen(R) treatment protocol for patients with Chronic Fatigue Syndrome (CFS). Ampligen, developed by HemispheRx Biopharma, Inc., is a new drug under development for potential restoration of physical and cognitive functions of patients with CFS. This is the first specific FDA approval for treatment with cost recovery for this disorder. An estimated 500,000-to-2,000,000 patients in the U.S. suffer from CFS. This first approval for treatment with cost recovery means that patients reimburse the cost of the drug, allowing the company to recover a portion of the research, development and manufacturing costs associated with its development to date. Patients also absorb the cost of twice weekly drug infusion and lab tests. The treatment program in the U.S. initially will be directed towards the most severely disabled patients who are expected to be treated for 24 weeks followed by medical evaluation and reassessment. Simultaneously, sales of Ampligen have also begun in Montreal and Vancouver under the Canadian Emergency Drug Release Program. The approval in Canada covers patients in all stages of the disease, where the CFS patient population is estimated at more than 100,000. As in the United States, patients on the treatment may also absorb additional costs associated with drug infusion and medical oversight. The five sites approved in the United States are New York City, Charlotte, NC, Houston, TX, Charleston-area, SC, Philadelphia-area, PA and San Francisco Bay/Reno, NV area. All sites have received or are awaiting confirmation from their local Review Boards or Ethics Committees that they may begin treating patients with Ampligen. Treatment will begin as soon as customary baseline lab tests, scheduled over two weeks, are completed. In addition to the five approved sites, an additional twelve sites are under consideration for approval to treat CFS patients with Ampligen. CFS, also known as Chronic Fatigue Immune Dysfunction (CFIDS), or Myalgic Encephalomyelitis (ME), is a serious and complex illness that affects a vast number of different body systems. It is generally characterized by disabling fatigue, problems with concentration and memory, flu-like symptoms, pain in the joints and muscles, sleep disorders, etc. As a result, the Centers for Disease Control (CDC) has assigned the disorder to its priority one list of "new and reemerging infectious diseases" in the U.S. Hemispherx is a biopharmaceutical company engaged in the manufacture and global clinical development of new drug entities in the nucleic acid (NA) class for chronic viral disease and disorders of the immune system. The Company is working with regulatory agencies, physicians and patients to help ensure that epidemic diseases are prevented, managed and cured with maximum benefit and minimum costs to patients and society. This press release contains statements of a forward-looking nature regarding future events. These statements are only predictions and actual events may differ materially. Please refer to documents that Hemispherx files from time to time with the Securities and Exchange Commission for a discussion of certain factors that could cause actual results to differ materially from those contained in the forward-looking statements. More information on: Hemispherx, Ampligen
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