In November, 2015 Tocagen reported interim data from three ongoing Phase 1 studies of Toca 511 in combination with Toca FC in 116 patients with recurrent high grade glioma. The data continued to show potential benefits, including a favorable safety profile and extended overall survival (OS) in patients with recurrent high grade glioma (HGG) compared to historical benchmarks
In 43 patients with recurrent HGG, mostly with glioblastoma, where Toca 511 was administered at the time of tumor removal, landmark survival at 12 and 24 months was 52.5 percent and 31.6 percent, respectively, a statistic that is not typically reported in recurrent brain cancer studies due to low survival at 2 years post recurrence.
Furthermore, the subset of 30 patients that mirrors entry criteria and the clinical setting for enrollment in Toca 5, our Phase 2/3 clinical trial, had an approximate six-month improvement in median overall survival compared to historical benchmarks.
Tocagen has obtained Fast Track designation from the U.S. Food and Drug Administration for Toca 511 & Toca FC for the treatment of recurrent HGG. The Fast Track program is intended to expedite or facilitate the process for reviewing a new product if it is intended for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition.
Tocagen has also obtained orphan drug designation for the treatment of GBM. Orphan drug designation makes Toca 511 & Toca FC eligible for a period of orphan drug exclusivity, if approved, subject to certain exceptions.