Galena Biopharma Discontinues NeuVax Phase 3, PRESENT Interim Analysis

(RTTNews) - Galena Biopharma, Inc. (GALE) announced the recommendation from the Independent Data Monitoring Committee or IDMC on the interim analysis for Galena's NeuVax (nelipepimut-S) Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVaxTreatment) clinical trial.

On June 27, 2016, the IDMC recommended that the PRESENT trial be stopped due to futility. This planned safety and futility interim analysis was triggered after 70 qualifying disease free survival (DFS) events were reached, and a total of 71 events were reviewed by the IDMC.

"We are extremely disappointed with the outcome of the PRESENT futility analysis," said Mark Schwartz, President and Chief Executive Officer.