Tocagen Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead oncology product, Toca 511 & Toca FC, for the treatment of recurrent high grade glioblastoma, which includes both glioblastoma multiforma and anaplastic astrocytoma. A clinical study called Toca 5 will be initiated later this year in patients with recurrent glioblastoma or anaplastic astrocytoma.
The FDA’s Fast Track program is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need, with the goal of getting important new drugs to patients earlier. Fast Track designation allows for more frequent interactions with the FDA review team, including meetings to discuss the drug’s development plan to support potential drug approval and the opportunity to submit sections of an NDA on a rolling basis as data become available.
Toca 511 & Toca FC is an immuno-oncology therapy designed to selectively transform cancer cells to produce a chemotherapy drug within the tumor while also activating the immune system against the tumor with local and systemic benefits. Toca 511 is a retroviral replicating vector (RRV) that selectively delivers a gene for the enzyme cytosine deaminase to the cancer cells. The patient then takes oral cycles of Toca FC, a novel formulation of an antifungal drug, which is converted into the FDA-approved chemotherapy drug, 5-fluorouracil (5 FU). As a result, infected cancer cells are selectively killed, subsequently activating the immune system to recognize cancer cells while leaving healthy cells unharmed. 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.
Source: Tocagen Inc.
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