This decision was based upon positive clinical data generated in a 500-subject, Phase I/II study recently completed by Iomai. Guided by data from this study, Iomai will begin a Phase II dose-ranging study designed to identify the optimum dose of antigen and adjuvant that can be used in a one-dose or two-dose regimen to enhance the immune response to a H5N1 influenza vaccine.
Stanley Erck, president and CEO of Iomai, said: “The Iomai immunostimulant patch has the potential to change how we react to an influenza pandemic, and we will move ahead quickly with the development of this technology. Based on the data from this new Phase II study, Iomai and HHS will evaluate whether to proceed next with a pivotal Phase III trial.”