23 February 2017 - Tocagen today announced the U.S. FDA has granted Toca 511 & Toca FC breakthrough therapy designation for the treatment of patients with recurrent high grade glioma.
Toca 511 & Toca FC is currently under evaluation in an international, randomised Phase 2/3 clinical trial, which is designed to serve as a potential registrational study. The trial involves patients with first or second recurrence of glioblastoma or anaplastic astrocytoma who are undergoing resection.
Enrolment in the Phase 2 portion of the trial has completed and top-line results are anticipated in the first half of 2018.