Brain tumor drug gets PRIME designation
US cancer-selective gene therapy company Tocagen (Nasdaq: TOCA) has announced that its Toca 511 (vocimagene amiretrorepvec) treatment of patients with high grade glioma (HGG), a type of brain tumor, has received PRIME (PRIority MEdicines) designation from the European Medicines Agency (EMA).
Toca 511, an investigational biologic, and an investigational small molecule, Toca FC, are designed to be used together. They are Tocagen’s lead product candidate, a cancer-selective immunotherapy currently under evaluation in an international, randomized Phase II/III 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 included clinical data from a Phase I resection study in patients with recurrent brain cancer and results from various preclinical models.
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