The primary objectives of the trial include determining the minimum effective immunomodulatory dose of cyclophosphamide to obtain successful immune modulation. Secondary objectives include the safety profile of the combination and gathering any evidence of anti-tumor activity.
The trial (REO 012) is an open-label, dose-escalating, non-randomized trial of Reolysin given intravenously with escalating doses of cyclophosphamide. A standard dose of Reolysin is administered intravenously over five consecutive days, while an intravenous dose of cyclophosphamide is administered three days before Reolysin treatment and continues through the course of the treatment cycle.
James Spicer of King’s College in London, the principal investigator, said: “We are really looking forward to treating patients in this trial. The hope is that it will provide valuable information about the relationship between oncolytic viral therapy and the immune response of the patient.”