Standard treatment for newly diagnosed high grade glioma (Grade 3 or Grade 4) includes surgical removal of as much of the tumor as possible followed by radiation therapy and chemotherapy with temozolomide. Unfortunately, despite these measures, the tumor often recurs and participation in a clinical trial may be recommended.
Tocagen™ is conducting investigational clinical trials of Toca 511 & Toca FC at select neuro-oncology centers in the United States (participating centers are shown in the right hand panel of this page).
- Has a recurrent high grade glioma (Grade 3 or Grade 4)
- Has had prior surgery, radiation and chemotherapy
- Is at least 18 years of age
In these studies, Toca 511 is given one time by either injection into the brain tumor (Intratumoral Study), into the wall of the resection cavity at the time of tumor removal (Toca 5 Study, Resection Study), or intravenously with a subsequent injection into the wall of the resection cavity at the time of tumor removal (Intravenous Study). After waiting several weeks to allow Toca 511 to spread through the tumor, repeat courses (cycles) of oral Toca FC (extended-release formulation of 5-FC) are taken. In addition to the direct killing of cancer cells, we believe that the immune system is selectively activated by the local tumor killing, with resultant systemic anti-tumor immunity. A schematic of how Toca 511 and 5-FC is designed to work is shown below.
Looking Ahead: Future Development of Toca 511 & Toca FC
Based on preclinical data, we believe Toca 511 & Toca FC may have therapeutic benefit in multiple other solid tumor cancers. We are also encouraged by our ongoing intravenous clinical trial in patients with HGG in which Toca 511 crossed the blood brain barrier and was detected selectively in HGG brain tumors. We are now planning to initiate a clinical trial, Toca 6, for patients with metastatic breast, lung, colorectal, melanoma and renal cancers, all of which can spread to the brain and other organs. In this trial, Toca 511 will be given intravenously and we plan to evaluate viral presence in tumor samples and evaluate tumor shrinkage.
Based on findings from our preclinical research and clinical trials to date, we plan to investigate the combination of Toca 511 & Toca FC with other treatments. We are planning to initiate a clinical trial, Toca 7, for patients with newly diagnosed HGG where our treatment will be investigated in combination with surgery, radiation, and chemotherapy. We are also considering the combination of our treatment with other immunotherapies.
Learn more about Tocagen Clinical Trials:
Brain Cancer (High Grade Glioma)
Toca 511 & Toca FC