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Programs: Brain Cancer (High Grade Glioma)
Brain Cancer and Gene Transfer
Tocagen believes that we are at the forefront of next generation therapeutics for treating brain cancer based on gene transfer technology.
We are initially focused on an aggressive type of brain cancer, namely recurrent High Grade Glioma (HGG), which includes Glioblastoma Multiforme (GBM) and anaplastic astrocytomas.
Toca 511 & Toca FC
Toca 511, the key novel component of Tocagen’s first Product Candidate (Toca 511 & Toca FC), was developed using our breakthrough Controlled Active Gene Transfer (CAGT) technology. Tocagen is currently investigating Toca 511 & Toca FC in subjects who have recurrent High Grade Gliomas (HGG). Tocagen is also planning to study Toca 511 & Toca FC in patients with newly diagnosed (primary) brain cancer and in patients with cancers that have metastasized to the brain.
Brain Cancer
According to The Central Brain Tumor Registry of the United States (www.CBTRUS.org), more than 124,000 persons in the United States were living with a diagnosis of primary brain and central nervous system (CNS) cancer in 2004. In 2012, there will be an estimated 22,910 new cases and 13,700 deaths indicating that brain and CNS cancer is one of the most deadly forms of cancer (American Cancer Society: www.cancer.org). The incidence of primary malignant brain cancer has been increasing by about 1.2% each year over the last 30 years (National Comprehensive Cancer Network, NCCN: www.nccn.org). In addition to primary brain and CNS cancer, the NIH estimates that 10-30% of adults with cancer will develop brain metastases (www.nlm.nih.gov). Taking the midpoint of this range and based on an annual incidence of cancer (excluding skin cancers) of 1,596,670 (www.seer.cancer.gov), the annual US incidence of brain metastases is approximately 319,334. Brain metastases are commonly diagnosed in patients with melanoma, breast, and lung cancer.
In the US, each year there are approximately 11,000 new cases of High Grade Glioma (HGG). HGG refers to Grade III and Grade IV gliomas which include anaplastic astrocytoma, anaplastic oligodendroglioma, and Glioblastoma Multiforme (GBM). GBM is the most common form of HGG, accounting for about 50% of all primary brain cancers. Approximately 9,000 new cases are diagnosed each year in the United States (www.CBTRUS.org). Overall, the 1, 5, and 10-year survival rates for patients with GBM are 33.67%, 4.46%, and 2.7% respectively, making it the most fatal form of all primary brain and CNS cancers. Standard of care for the treatment of GBM has essentially remained unchanged for several decades (surgery, radiation, and chemotherapy with an alkylating agent such as temozolamide). Over the last 40 years, optimal treatment from first diagnosis of GBM has improved survival from about 2.5 months to about 12 months (Holland, E.C., PNAS, 2000). In a landmark study led by Roger Stupp, MD, the median survival of subjects was 14.6 months with surgery, radiotherapy and temozolomide and 12.1 months with only surgery and radiotherapy (Stupp, R., NEJM, 2005). Therefore, the need for a breakthrough treatment in this devastating disease is a priority for modern medicine.
Unlike some cancers, GBM does not spread to other organs and it causes adverse symptoms and death by creating pressure on vital brain structures. Thus, control of the brain cancer itself should result in significant improvement in quality of life and outcomes.
Key Facts About HGG Brain Cancer
- HGG include grade 3 and grade 4 tumors such as anaplastic astrocytoma, anaplastic oligodendroglioma, and Glioblastoma Multiforme (GBM).
- Each year, there are over 11,000 newly diagnosed cases of HGG in the US.
- GBM, the most common form of HGG, has an annual incidence of approximately 9,000 in the US and almost all GBM tumors recur.
- GBM is a highly aggressive cancer that infiltrates surrounding brain tissue.
- GBM is the most deadly form of brain cancer with a 5 year survival of <5%.
- Maximal current therapy from several decades of effort (surgery, radiation and temozolomide) has extended median survival to about 14 months.
- Relatively, more years of productive life are lost in patients with GBM brain cancer than any other cancer.
- Temodar (temozolamide) is FDA approved for the treatment of GBM and anaplastic astrocytoma. In patients with GBM, temozolomide (Temodar) provides a median survival advantage of 10 weeks.
- Avastin (bevacizumab) is FDA approved for the treatment of recurrent GBM. Currently, there are no data demonstrating increased survival with bevacizumab (Avastin).
Animal Health Program
Tocagen is currently evaluating Toca 511 & Toca FC in companion dogs afflicted with brain cancer. If you would like more information about this clinical study, please click here or contact us through the Canine Patient Inquiry Form.
Product Candidates
Toca 511 & Toca FC
Also see:
Breakthrough Technology
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