FDA Authorizes Alferon LDO Clinical Study For Treatment And Prevention Of Influenza
PHILADELPHIA, Jan. 4, 2011 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company" or "Hemispherx") announced today that the Food and Drug Administration (FDA) has lifted a clinical hold on its Phase II, double-blind, adaptive-design, randomized, placebo-controlled, dose-ranging study of Alferon® LDO [oral interferon alfa-n3 (human leukocyte derived)] for the prevention and treatment of influenza. The FDA noted that they had completed the review of a submission dated November 12, 2010 which provided a Complete Response to the Agency's reasons for continuing this study on clinical hold. In previous 10-K and the recent 10-Qs, Hemispherx provided background information on the clinical hold items.
Dr. William A. Carter, Chairman and Chief Executive Officer, stated, "We are very pleased to have resolved these issues with the FDA and now turn our focus to how best to move this program forward with possible clinical studies in the U.S. and in other parts of the world." Oral administration of Alferon® LDO, an experimental therapeutic, with its anticipated affordability, ease of administration, and broad range of potential bioactivity, could be a breakthrough treatment or preventative for viral diseases.
Alferon® Low Dose Oral (LDO)Alferon® LDO [Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)] is an experimental low-dose, oral liquid formulation of Natural Alpha Interferon and like Alferon N Injection® should not cause antibody formation, which is a problem with recombinant interferon. It is an experimental immunotherapeutic believed to work by stimulating an immune cascade response in the cells of the mouth and throat, enabling it to bolster systemic immune response through the entire body by absorption through the oral mucosa. Oral interferon could be economically feasible for patients and logistically manageable in development programs in third-world countries primarily affected by influenza and other emerging viruses. Oral administration of Alferon® LDO, with its anticipated affordability, low toxicity, expected non-production of antibodies, and broad range of potential bioactivity, could be a breakthrough treatment or prevention for viral diseases.
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