GlobeImmune Inc. announced that a randomized Phase 2 clinical trial designed to investigate the safety and efficacy of GI-6301 in combination with radiation therapy in patients with chordoma is open for enrollment at the National Cancer Institute. The Company believes that the GI-6301 Tarmogen(R), exclusively licensed to Celgen Corporation, has demonstrated promising initial results in chordoma patients evaluated in a recent Phase 1 study. The literature suggests that, while radiation can often achieve temporary local control, it rarely results in tumor shrinkage.

The GI-6301-02 Phase 2 clinical trial is a randomized, double-blind, placebo controlled trial of GI-6301, in combination with standard of care radiation for patients with locally advanced, unresectable chordoma. The primary endpoint for the trial will be overall response rate (ORR) defined as complete response (CR) or partial response (PR) by RECIST, a scoring system used to evaluate tumor response, after up to 24 months of treatment. Participants randomized to the placebo arm will be allowed to cross-over to receive GI-6301 at time of confirmed disease progression.

This Phase 2 trial was designed together with the Company's collaborators at the NCI.