Galena tanks as it pulls the plug on NeuVax trial

29 June 2016

Shares of USA-based Galena Biopharma (Nasdaq: GALE) plunged 85.5% to $0.29 in by mid-morning trading, when it was revealed that its most advanced pipeline product, cancer vaccine NeuVax (nelipepimut-S), had failed.

The Independent Data Monitoring Committee (IDMC), following the interim analysis for Galena’s NeuVax Phase III PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) clinical trial, on June 27, 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. An interim analysis of 71 qualifying disease-free survival events failed to show a significant effect from treatment with NeuVax.

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