The European Medicines Agency (EMA) has granted orphan medicinal product (orphan drug) designation to Tocagen’s Toca 511 (vocimagene amiretrorepvec) & Toca FC (flucytosine) for the treatment of patients with glioma, a type of brain tumor. 

Toca 511 & Toca FC is currently under evaluation in a global Phase 3 trial, called Toca 5, involving patients with first or second recurrence of high-grade glioma (HGG), namely glioblastoma or anaplastic astrocytoma, who are undergoing resection.
 

“The EMA’s granting of orphan medicinal product designation to Toca 511 & Toca FC emphasizes the urgent need for new therapies that may benefit patients living with glioma,” said John Wood, vice president, regulatory affairs and quality, at Tocagen. “We are committed to working closely with the EMA under this orphan designation and our previously announced PRIME (PRIority MEdicines) designation to bring our product candidate to European patients and physicians as quickly as possible.”

Gliomas, particularly HGGs, are among the most common and aggressive primary brain cancers. The total number of patients with HGG expected to be diagnosed in 2018 is approximately 190,000 worldwide and approximately 36,000 in Europe.