On August 23, 2018 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, reported the Toca 5 pivotal Phase 3 trial continues without modification following a planned first interim analysis of data conducted by an Independent Data Monitoring Committee (IDMC) (Press release, Tocagen, AUG 23, 2018, View Source;p=RssLanding&cat=news&id=2364611 [SID1234529156]). The IDMC completed its analysis at 50% of events occurring in patients with brain cancer and recommended the trial continue without modification. The global trial is enrolling robustly and nearing full enrollment.
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"We are pleased with the outcome of the interim analysis of the Toca 5 trial by the independent Data Monitoring Committee and the global trial continues. The Toca 5 trial is nearing completion of full enrollment of patients ahead of the projected schedule. We plan to conduct the second interim analysis in the first half of 2019 after 75% of events have occurred," said Asha Das, M.D., senior vice president and chief medical officer of Tocagen.
Toca 5 is a Phase 3, randomized, multi-center study evaluating the safety and efficacy of Toca 511 & Toca FC compared to standard of care in patients undergoing resection for recurrent high grade glioma (HGG). The primary endpoint of the trial is overall survival (OS). The statistical plan for the primary endpoint assumes a median OS of 9.8 months for the control arm versus 14.3 months for the Toca 511 & Toca FC arm. A total of 257 events will provide the study with 85% power to detect a hazard ratio of 0.685. The U.S. Food and Drug Administration (FDA) has granted Toca 511 & Toca FC Breakthrough Therapy Designation for the treatment of recurrent HGG and the European Medicines Agency (EMA) has granted Toca 511 PRIME (PRIority MEdicines) designation for the treatment of glioma. More information about the Toca 5 trial can be found on ClinicalTrials.gov using the clinical trial identifier NCT02414165.
About Toca 511 & Toca FC
Tocagen’s lead product candidate is a two-part cancer-selective immunotherapy comprised of an investigational biologic, Toca 511 and an investigational small molecule, Toca FC. Toca 511 (vocimagene amiretrorepvec) is a retroviral replicating vector (RRV) that selectively infects cancer cells and delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered, extended-release formulation of the prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells in the tumor microenvironment resulting in anti-cancer immune activation and subsequent tumor killing.