Pharmaceutical Business review

Generex to conduct first human H5N1 trial

Antigen Express, a wholly owned subsidiary of Generex, designed the vaccine using its proprietary platform technology and has been conducting preclinical studies since 2004.

Generex commented that the vaccine being developed by Antigen Express is based upon simple peptide-synthesis technology and can thus be manufactured easily, and at inexpensive cost.

The vaccine is unlike traditional egg-based vaccines that rely on biological systems for vaccine production, making their availability during a pandemic extremely limited. The preclinical studies conducted with the synthetic vaccine suggest that it may be used with more traditional vaccines to extend their utility and prevent mortality.

The Antigen Express vaccine consists of specific fragments of the H5 protein from the H5N1 influenza virus that have been modified to enhance their potency in stimulating CD4+ T helper cells. The T helper cells are essential in the development of a strong immune response against the virus.

“The trials in Lebanon will complement nicely the studies planned for the US,” said Dr Eric von Hofe, president of Antigen Express. “We know that bird flu is a threat that shows no signs of going away soon. Coupled with the lack of any widely available vaccine, it is paramount to begin testing the synthetic vaccine being developed at Antigen Express as rapidly as possible.”