EMA Grants PRIME Designation to Toca 511 in High-Grade Glioma
The European Medicines Agency granted Tocagen a PRIME designation for its Toca 511 (vocimagene amiretrorepvec) treatment for high-grade glioma.
Toca 511 and Toca FC are currently under evaluation in an international, randomized Phase II/III clinical trial, in patients with first or second recurrence of glioblastoma brain tumors or anaplastic astrocytoma.
The PRIME designation was based on clinical data from a Phase I resection study in patients with recurrent brain cancer and results from various preclinical models. The data also resulted in an FDA Breakthrough Therapy designation in February 2017.