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Tocagen announced that the FDA has granted Fast Track status to Toca 511 and Toca FC for the treatment of recurrent high grade glioma, which includes glioblastoma and anaplastic astrocytoma.
Toca 511 and Toca Fc will be evaluated for recurrent glioblastoma or anaplastic astrocytoma in a registrational study, Toca 5, later this year. Interim data from two ongoing clinical trials have shown extended survival compared to historical benchmarks, encouraging dose response effect and durable tumor shrinkage. A study evaluating Toca 511 and Toca FC for additional cancer indications is also planned for 2016.
RELATED: Orphan Drug Designation Granted to Glioblastoma Multiforme Therapy
Toca 511 is a retroviral replicating vector (RRV) which delivers a gene for the enzyme cytosine deaminase (CD) to the cancer cells. Toca FC is an oral antifungal that is converted to 5-fluorouracil (5-FU) that selectively kills infected cancer cells. Immune activation locally in the tumor occurs through a combination of mechanisms which leads to breaking of immune tolerance and activation of the immune system selectively against the cancer cells.
For more information call (858) 412-8400 or visit Tocagen.com.
