Drug Development

Galena implodes as trial monitors call a halt to a failed PhIII cancer study

Shares of Galena ($GALE) were eviscerated this morning, dropping 78% after the biotech announced that it had stopped a Phase III study of its lead cancer vaccine NeuVax after the monitoring committee flagged it for failing to help breast cancer victims.

Proving yet again that an entire wave of cancer vaccines has been a disappointing flop, the San Ramon, CA-based biotech says it will now assess the program — but it doesn’t look good.

Galena CEO Mark W. Schwartz

Galena CEO Mark W. Schwartz

“To date, the trial has not been un-blinded other than by the IDMC, and we need to evaluate the data,” says CEO Mark W. Schwartz in a statement. “We expect to host a conference call next week to provide a preliminary review of the PRESENT trial and an update on all of our immunotherapy and hematology clinical development programs.”

NeuVax, or nelipepimut-S, is designed to whip up a T cell response targeting HER2 positive cancer cells. Galena believed that it had the right design to hunt down and destroy migrating cells that could trigger a recurrence of cancer. But like several predecessors, that proved not to be the case.

Galena spelled out the disaster in a filing with the SEC:

“On 24 June 2016, the assembled Independent Data Monitoring Committee met to review the efficacy and safety data available for the aforementioned protocol. At this time the DMC recommends that the study be stopped for futility unless it is determined that there has been a systematic reversal in the study drug treatments in the two arms, in which case the IDMC should reevaluate the clinical evidence. The IDMC recommends that this be investigated as quickly as possible and, in the meantime, that this information be disclosed only to any individual(s) with a need to know about the procedures used to clarify the current situation. Finally, the DMC requests that Galena Biopharma inform the IDMC members of the outcome of this investigation and any decision with respect to discontinuation of the clinical trial as soon as possible.”


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