05/21/2019 | Press release | Distributed by Public on 05/21/2019 14:48
Tocagen Inc. (NASDAQ:TOCA), a clinical-stage, cancer-selective gene therapy company, today announced the Toca 5 Phase 3 clinical trial evaluating Toca 511 & Toca FC in patients with recurrent high grade glioma (HGG) continues without modification following a planned interim analysis of data conducted by an Independent Data Monitoring Committee (IDMC). The IDMC completed its analysis and recommended the trial continue without modification. The global trial enrolled patients across two periods of time and completed full enrollment of 403 patients in November 2018.
Tocagen Inc. (PRNewsfoto/Tocagen Inc.)
'We are encouraged by the recommendation from the IDMC to continue the Toca 5 trial without modification and are looking forward to reporting the final analysis of the Toca 5 trial by the end of the year,' said Marty Duvall, chief executive officer of Tocagen. 'We believe the longer-term follow-up of patients in the final analysis, particularly for those randomized in the second enrollment period, will be important in assessing both primary and secondary endpoints.'
The Toca 5 trial is one of the largest randomized trials conducted in patients with recurrent high grade glioma. The international trial is a Phase 3 multi-center trial evaluating the safety and efficacy of Toca 511 & Toca FC compared to standard of care in patients undergoing resection for recurrent high grade glioma (HGG). The primary endpoint of the trial is overall survival (OS). The statistical plan for the primary endpoint assumes a median OS of 9.8 months for the control arm versus 14.3 months for the Toca 511 & Toca FC arm. A total of 257 events will provide the trial with 85% power to detect a hazard ratio of 0.685. The U.S. Food and Drug Administration (FDA) granted Toca 511 & Toca FC Breakthrough Therapy Designation for the treatment of recurrent HGG and the European Medicines Agency (EMA) granted Toca 511 PRIME (PRIority MEdicines) designation for the treatment of glioma. More information about the Toca 5 trial can be found on ClinicalTrials.gov using the clinical trial identifier NCT02414165.