It is announced that all eight subjects of the first cohort of our phase I study FMPV-1-01 in healthy volunteers now are enrolled. All eight subjects have received their first dose of FMPV-1 co-administered with adjuvant GM-CSF without observation of related adverse reactions.
The phase I study will assess safety and immune response in up to 16 subjects. In a first cohort eight subjects will be enrolled and, depending on the results, a second cohort of another eight subjects given a higher dose of FMPV-1 will follow. It is aimed at completing enrolment and active treatment in the study within the next six months.