Generex' subsidiary to submit flu vacc to FDA

Canada's Generex Biotechnology says that its wholly-owned immunotherapeutics subsidiary, Antigen Express, will meet with the Food and Drug Administration on February 10 to discuss the filling of an Investigational New Drug application for its novel H5N1 avian influenza vaccine, Li-Key/H5.

The firm says that its Antigen Express technology circumvents the problem of the slow rate of manufacture and requirement of several treatments associated with current influenza vaccines because it uses a synthetic peptide to induce a strong T-helper cell immune response. The company argues that, because its vaccine can be manufactured synthetically and is not reliant on expensive cell culture or vaccine cultivation in hens eggs, it is possible to produce large quantities of the product using its existing facilities.