What is recurrent High Grade Glioma?
Recurrent High Grade Glioma (HGG) refers to Grade 3 or Grade 4 brain tumors (e.g. glioblastoma, anaplastic astrocytoma) that have returned or increased in size following treatment, typically involving surgery, radiation therapy and/or chemotherapy.
What is a clinical research study?
Clinical research studies are designed to evaluate new investigational treatments that have not yet been proven to be safe and effective in people and are not licensed by the Food & Drug Administration (FDA) or any other government agency. Investigational treatments like Toca 511 (vocimagene amiretrorepvec) & Toca FC (extended-release version of 5-fluorocytosine) can only be administered in a clinical research study.
What is Toca 511 & Toca FC?
Toca 511 & Toca FC is an investigational combination product that is designed to deliver chemotherapy selectively to the tumor and activate the immune system against the tumor. Toca 511 is a live gamma retrovirus that has been built to infect and carry a gene selectively into cancer cells. Toca FC is a special formulation of a type of antibiotic, called 5 FC, which is approved by the FDA to treat fungal infections. The gene (called CD) in Toca 511 is designed to turn 5 FC into 5 FU, which is a potent anti-cancer drug, selectively within the tumor.
The proposed mechanism of action video can be seen here.
What is the Toca 5 study?
Toca 5 is a Phase 2/3 clinical trial that will evaluate the safety and effectiveness of Toca 511 & Toca FC in people with recurrent HGG. Approximately 170 people will be enrolled in the Phase 2 portion of the study at leading neuro-oncology centers in the United States, Canada and other countries around the world.
Specifically, the Toca 5 trial is a Phase 2/3 randomized, open-label study of Toca 511 and Toca FC versus standard of care.
A patient may qualify for this study if the patient:
- has glioblastoma or anaplastic astrocytoma at 1st or 2nd recurrence (including this recurrence)
- has had prior surgery, radiation and chemotherapy
- is between 18 years old and 75 years old
How can I learn more about the Toca 5 study?
Toca 511 & Toca FC are investigational products. An investigational product is one that has not been proven to be safe and effective for this use and is not licensed by the US Food and Drug Administration or any other government agency. An investigational product can only be administered in a research study.