The trial is being conducted in patients with recurrent high-grade glioma

An Independent Data Monitoring Committee recommended the study continue without modification

Reports confirm that Tocagen Inc, a clinical-stage and cancer-selective gene therapy firm, has recently announced that the pivotal Phase 3 trial of Toca 5, to evaluate Toca FC and Toca 511 in patients having recurrent high-grade glioma (HGG), would continue without any modification.

The move apparently follows a strategic interim evaluation of data organized by an Independent Data Monitoring Committee (IDMC). The IDMC completed its analysis and recommended the clinical trial can continue without modifications. The global clinical trial enrolled patients from over two periods of time and in November 2018, had completed full enrollment of 403 patients.

According to Marty Duvall, CEO of Tocagen, suggestions from the IDMC have encouraged the company to continue with the Toca 5 clinical trial without any modification and it expects to report the final evaluation of the Phase 3 clinical trial of Toca 5 by 2019 end.

In the final analysis, the long-term follow-up of the patients, mainly for those randomized in the second enrollment period, will be vital in evaluating both primary and secondary endpoints.

Seemingly, the Toca 5 clinical trial is one of the biggest randomized trials conducted in patients with recurrent high-grade glioma. The global trial is a Phase 3 multi-center trial evaluating the efficacy and safety of Toca FC and Toca 511 as compared to standards of care in patients experiencing resection for recurrent HGG.

Citing reliable sources, a total of 257 events will offer the clinical trial 85% power to identify a hazard ratio of 0.685. The European Medicines Agency had approved Toca 511 PRIME or Priority medicines designation for the treatment of glioma, while the U.S. FDA had given it Breakthrough Therapy Designation for the treatment of recurrent HGG.

The lead product of Tocagen is a two-way cancer-selective immunotherapy including Toca 511, a new investigational biologic and Toca FC, a new investigational small molecule.

 Source Credit: https://finance.yahoo.com/news/tocagens-toca-5-pivotal-phase-200500398.html