Tocagen Inc (Nasdaq:TOCA) has completed the planned enrolment of 380 patients in a pivotal Phase 3 trial of its lead product candidate, a potential new treatment for an aggressive form of brain cancer, the gene therapy company reported on Wednesday.

This randomised, multi-centre study, known as Toca 5, will evaluate the safety and efficacy of Toca 511 & Toca FC compared to standard of care in patients undergoing resection for recurrent high grade glioma (HGG), one of the most common and aggressive primary brain cancers.

Toca 511 & Toca FC is a two-part cancer-selective immunotherapy comprised of an investigational biologic, Toca 511, and an investigational small molecule, Toca FC.

Completing enrolment in Toca 5 triggers the next milestone payment of USD2m from ApolloBio, the licensor of Toca 511 & Toca FC within the greater China region.

Tocagen announced in August that the Toca 5 study would continue without modification after an independent data monitoring committee completed the first interim analysis. The second interim analysis is expected in the first half of 2019, followed by the final planned safety and efficacy analyses by the end of 2019.