Hemispherx Biopharma, Inc., a specialty pharmaceutical company, engages in the clinical development of new drug therapies based on natural immune system enhancing technologies for the treatment of viral and immune based chronic disorders in the United States. Products Ampligen: The company’s double-stranded RNA (ribonucleic acid) drug product, trademarked Ampligen, is an experimental, unapproved drug that would be administered intravenously. Ampligen is undergoing clinical development for the treatment of Chronic Fatigue Syndrome Treatment (CFS). Ampligen has received various designations, including Orphan Drug Product Designation (FDA), Treatment IND with Cost Recovery Authorization (FDA) and ‘promising’ clinical outcome recognition based on the evaluation of certain summary clinical reports (AHRQ or Agency for Healthcare Research and Quality). Ampligen represents the first drug in the class of large (macromolecular) RNA (nucleic acid) molecules to apply for New Drug Application (NDA) review. Alferon N Injection Alferon N Injection is the registered trademark for the injectable formulation of natural alpha interferon, which was approved by the FDA for the treatment of certain categories of genital warts. Alferon is the only natural-source, multi-species alpha interferon approved for sale in the U.S. for the intralesional (within lesions) treatment of refractory (resistant to other treatment) or recurring external genital warts in patients 18 years of age or older. Alferon N Injection contains a multi-species form of alpha interferon. The company’s natural alpha interferon is produced from human white blood cells. Alferon LDO (Low Dose Oral) Alferon LDO is an experimental low-dose, oral liquid formulation of Natural Alpha Interferon. It is an experimental immunotherapeutic, which works 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. The company has an FDA authorized protocol to conduct a Phase II, double-blind, adaptive-design, randomized, placebo-controlled, dose-ranging study of Alferon LDO for the prophylaxis and treatment of seasonal influenza of more than 200 subjects. Patents and Non-Patent Exclusivity Rights As of December 31, 2014, the company had 25 patents worldwide with 27 additional pending patent applications comprising its intellectual property. History Hemispherx Biopharma, Inc. was founded in 1990.
hemispherx biopharma inc (HEB:NYSE Amex)
One Penn Center
1617 JFK Boulevard
Philadelphia, PA 19103
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