Hemispherx BioPharma (HEB)

[STOCK_MOMO]

The two platform drugs of Hemispherx, Alferon(R) N and Ampligen(R), have certain unique structural attributes and developmental histories which suggest potential incremental value with respect to inclusion in various Ebola therapeutic cocktails under development. First, both drugs have mechanisms of action, which are multifaceted by working thru cellular "molecular cascades" (i.e. multiple mediators which protect cells from viral pathogenesis) rather than target viral targets whose specificity is vulnerable to mutational change. Cellular antiviral pathways of innate immunity are not subject to the mutational pressures of rapidly dividing viruses, which suggests that - even in the face of viral mutation - products activating innate immunity may continue to show biological activity. For example, work at the Japanese National Institutes of Health (Journal of Infectious Diseases (2007) 196:1313) indicated that Ampligen(R) affords wider cross-clade protection apparently through epitope expansion when added to existing influenza vaccines, an observation which has recently been extended clinically at the University of Alabama Clinical Research Center (Vaccine (2014) http://dx.doi.org/10.1016/j.vaccine.2014.07.078). Secondly, both drugs are unusually effective against highly virulent viruses such as SARS, as noted by Singapore investigators (Emerging Infectious Disease (2004) 10(4):581) and independent US health researchers (Virology (2009) 395:210). Alferon(R) N has also demonstrated superior potency to that shown by recombinant alpha interferons (AIDS Research Human Retroviruses.1993; 9:1115-111) and ability to afford apparent clinical benefit in the presence of antibodies against recombinant interferons (Journal of Interferon and Cytokine Research.2012; 32:95-9). Ampligen(R) is also active against the Respiratory Syncytial Virus (RSV) which is organized in a pattern very similar to EBOV genome and both the viruses are "negative sense" RNA viruses.