Tocagen reports Phase I data for glioma candidate, moves to Phase III

Tocagen Inc. (NASDAQ:TOCA) reported data from 53 evaluable patients with recurrent high-grade glioma in a Phase I trial showing that vocimagene amiretrorepvec/extended release flucytosine (Toca 511/Toca FC) led to a clinical benefit rate (CBR) of 30.2%, including 6 complete responses, plus 10 cases of stable disease. Median duration of response has not been reached at a median 35.1 month follow-up. The 12-, 24- and 36-month overall survival (OS) rates were 49.1%, 24.5% and 13.4%, respectively. The treatment was well tolerated. Patients received a single administration of 1.4x10⁷ to 4.8x10⁹ transducing units of Toca 511 into the resection cavity wall followed by 135 to 220 mg/kg cyclic Toca FC daily.

The open-label, U.S. trial's primary endpoint is safety and dose-limiting toxicities (DLTs). Secondary endpoints include OS and progression-free survival (PFS)...