Hemispherx BioPharma, Inc (AMEX:HEB) continues to surge today and has gained 49.4% from my alert yesterday at $.33. HEB has traded as high as $.494 during today’s trading session and last traded at $.493 for a gain of 20.18% from Friday’s close! HEB shares have traded as high as $.57 over the past 52 weeks, which is 13.5% off that high at last traded stock price.
On January 11, the Food and Drug Administration FDA granted an extension for the Company to modify its New Drug Application NDA in response to a Complete Response Letter CRL received November 25, 2009 for the Chronic Fatigue Syndrome therapeutic indication. The extension will remain open while Hemispherx submits an amended NDA.
On January 17, HEB was granted two new United States Patents for the use of Alferon® LDO (Low Dose Oral Interferon Alfa-n3). Alferon® LDO (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 known problem with recombinant interferon. Alferon® LDO 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 for prevention for viral diseases including influenza.
Last Thursday, ANMAT (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica), the agency responsible for the national regulation of drugs, foods and medical technology in Argentina, approved the sale and distribution of Alferon N Injection® (under the brand name “Naturaferon”) in Argentina. In June 2010, Hemispherx agreed to provide GP Pharm an option to market Alferon N Injection®, its FDA-approved natural interferon, in Argentina and other Latin America countries. In December 2010, GP Pharm exercised this right and in July 2011 GP Pharm submitted an application for approval to ANMAT.
Alferon N Injection® (Interferon alfa-n3 (human leukocyte derived)) is already approved in the US for the treatment of refractory or recurring external condylomata acuminate (genital warts) in patients 18 years of age or older. A major multi-million dollar investment scale-up of Alferon N Injection® manufacturing is underway at Hemispherx’s New Brunswick, NJ facility
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