24 July 2017 - Tocagen today announced the EMA has granted Toca 511 (vocimagene amiretrorepvec) PRIME (PRIority MEdicines) designation for the treatment of patients with 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.

The PRIME designation application was based on clinical data from a Phase 1 resection study in patients with recurrent brain cancer and results from various preclinical models. Clinical data include results published in Science Translational Medicine, including safety data, patient survival data and durable, complete or partial tumour shrinkage determined by independent radiology review. Pre-clinical data include results published in Neuro-Oncology detailing proposed mechanisms of action for Toca 511 & Toca FC. These clinical and pre-clinical data were also reviewed by the U.S. FDA and resulted in the granting of breakthrough therapy designation for Toca 511 & Toca FC in recurrent high grade glioma in February 2017.

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