Tocagen announces restructuring in wake of late-stage study failure of Toca 511, Toca FC in high-grade glioma

Tocagen on Thursday announced a restructuring of its operations as part of efforts to focus its resources on the clinical development of Toca 511 and Toca FC. Under the overhaul, the company is slashing its workforce by approximately 65% to about 30 employees by the end of the year.  

Last month, Tocagen's shares plunged more than 80% after the company reported that a Phase III study evaluating Toca 511 and Toca FC in patients with recurrent high-grade glioma undergoing resection failed to meet its primary endpoint of overall survival compared to standard-of-care treatment. Specifically, the findings revealed that median overall survival in patients receiving Toca 511 and Toca FC was 11.1 months, compared to 12.2 months in those given standard-of-care treatment, with the trial's secondary endpoints also failing to show a meaningful difference between the treatment arms. At the time, CEO Marty Duvall indicated that Tocagen would "be conducting an operational review."

Earlier this year, Tocagen disclosed that the study would continue as planned following an interim analysis conducted by an independent Data Monitoring Committee. The first planned interim analysis conducted in 2018 had also reached the same conclusion.

"With the extended cash position from this restructuring, our immediate priorities are to complete the analysis of the Toca 5 trial data, present the results thereof at the upcoming Society for Neuro-Oncology Annual Meeting in November 2019 and interact with the regulatory agencies to determine potential next steps for Toca 511 and Toca FC in recurrent high grade glioma," Duvall commented.

For related analysis, read ViewPoints: Tocagen takes one on the chin.

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