Hemispherx BioPharma (HEB)

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$HEB - Hemispherx Announces Primate Research Showing Alferon® LDO Protection from Pulmonary Damage Associated with Infection by Highly Pathogenic Influenza Virus

Monday, September 22, 2014

http://www.hemispherx.net/content/investor/default.asp?goto=799

….WHO Reports Global Flu Reaches 5 Year High in Southern Hemisphere

Philadelphia, PA, Monday, September 22, 2014: Hemispherx Biopharma, Inc. (NYSE MKT: HEB) (the “Company” or “Hemispherx”), announced today a peer-reviewed publication entitled “Protection from Pulmonary Tissue Damage Associated with Infection of Cynomolgus Macaques by Highly Pathogenic Avian Influenza Virus (H5N1) by Low Dose Natural Human IFN-a Administered to the Buccal Mucosa” in the current issue of Antiviral Research 2014. This publication is a collaborative project conducted at Viroclinics Biosciences BV, Rotterdam, an internationally recognized research facility for the study of influenza viruses. The biohazard laboratories are directed by Prof. Albert D. M. E. Osterhaus, an internationally known virologist specializing in the study of pandemic influenza. Highly pathogenic avian influenza A (H5N1) virus is endemic in wild birds in Asia and the Middle East, causing disease and transmissibility in domestic poultry. Infection of humans with H5N1 is associated with a high mortality rate (~60%) due to an alveolar destructive primary viral pneumonia frequently expressed clinically as acute respiratory distress syndrome (ARDS) (Abdel-Ghafar et al. NEJM 2008;358:261-273).

On September 8, 2014, the World Health Organization (WHO) said that the Southern Hemisphere’s flu season is still underway in many countries, notable in Australia, where some flu markers are at a 5-year high. In Northern Hemisphere countries, flu remained at interseasonal levels.

Based on a report of efficacy following oral administration of Alferon® N (Cummins et al. AJVR 2005;66:164-176), a study was initiated to determine whether an experimental low dose oral formulation (Alferon® LDO) of the natural IFN-a (Alferon N Injection®) could blunt the pathogenesis of a highly pathogenic influenza virus, H5N1. Using an established non-human primate model for H5N1 infection (Kuiken T, et al. Vet Pathol 2003;40:304-310), the collaborative team evaluated the potential for the prophylactic treatment of the pulmonary damage characteristic of fatal cases from primary influenza virus pneumonia using Alferon® LDO.

The study, funded by Hemispherx, demonstrates a dose-dependent prophylactic mitigation of the pulmonary damage characteristic of human fatal cases from primary influenza virus pneumonia with Alferon® LDO. At the highest oral dose (62.5 IU/kg body weight) used, there was a marked reduction in the alveolar inflammatory response in contrast to the hemorrhage and inflammatory response observed in the untreated control animals. The mitigation of severe damage to the lower pulmonary airway was observed without a parallel reduction in viral titers. Clinical trial data will be necessary to establish the prophylactic human efficacy of Alferon® LDO for highly pathogenic influenza viruses.

Alferon® N is the only natural alfa-interferon (IFN) which has received a full FDA approval for commercial sales. Alferon® N is approved under a biological product license for manufacture in Hemispherx’s New Brunswick, NJ facility for treatment of refractory or recurring general warts in adults. Alferon® LDO is an experimental oral formulation of Alferon® N that has been used in limited clinical trials to date in various viral conditions including HIV/AIDS.