Clinical Development Strategy
Phase 2b Trial
TVAX is currently planning to evaluate TVI-Brain-1 in a randomized Phase 2b study in patients with newly diagnosed glioblastomas. This multi-site trial expects to enroll a total of 60 - 72 patients and will measure overall survival as its primary endpoint, with 6-month progression-free survival a secondary endpoint. The company expects to initiate the study in Q3 2013 with data from the study’s interim analyses potentially available in 2014 and 2015.
The company believes that this trial may adequately support accelerated approval of TVI-Brain-1 by FDA and, at a minimum, would provide data that could be used to power the planned pivotal Phase 3 study.
Pivotal Phase 3 Trial
The company has received authorization from FDA to conduct a pivotal Phase 3 clinical trial with TVI-Brain-1. The planned trial will be a multi-center, randomized, open label, two parallel group study comparing the safety and efficacy of surgery, conformal radiotherapy and TVI-Brain-1 with surgery, conformal radiotherapy and temozolomide (Temodar) in patients with newly diagnosed glioblastoma.
The study is anticipated to enroll approximately 400 patients at approximately 30 clinical trial sites throughout the United States. Overall survival will be the primary endpoint for the study with 6-month progression free survival as the secondary endpoint.