Tocagen, a clinical-stage, cancer-selective gene therapy company, recently announced that it has completed patient enrolment approximately three months ahead of schedule for their Toca 5 Phase 3 clinical trial
The Toca 5 trial is a multi-centre clinical study consisting of 380 individuals with recurrent high-grade glioma. The aim of the trial is to test the safety and efficacy of a gene therapy compared to the current standard of care.
The gene therapy consists of two drugs, Toca 511 and Toca FC that have the ability to cross the blood - brain barrier and target the tumour cells. The drugs work together, with Toca 511 containing the protein which has the ability to convert Toca FC to the anti-cancer drug, 5-fluoracil.
High-grade gliomas are aggressive, fast-growing tumour that have a high chance of recurrence. Patients with recurrent high-grade gliomas have a median survival of approximately seven to nine months. With such poor prognosis, there is a huge unmet need for treatments to improve the survival and quality of life of patients with high-grade gliomas.
This treatment could have a tremendous clinical impact, as it could significantly increase the survival of individuals diagnosed with recurrent high-grade gliomas.
"Achieving our enrolment goal ahead of schedule is a testament to the enthusiasm and dedication of our investigators and study coordinators as well as the participating patients, families and patient advocates," said Asha Das, M.D., senior vice president and chief medical officer of Tocagen. "Achieving this enrolment goal takes us one step closer towards a potentially transformative new treatment option for patients with brain cancer."