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Galena’s breast cancer immunotherapy fails in late-stage trials; shares plunge

pharmafile | June 30, 2016 | News story | Research and Development, Sales and Marketing Galena Biopharma, Stock, breast cancer, drug trial 

Shares in Galena Biopharma (Nasdaq: GALE) dropped over 80% after the company said an independent Data Monitoring Committee recommended that the Phase III study of its NeuVax (nelipepimut-S) be stopped due to futility.

Mark Schwartz, chief executive officer, said: “We are extremely disappointed with the outcome of the Present futility analysis.”

The trial was evaluating NeuVax plus GM-CSF versus placebo plus GM-CSF to prevent breast cancer recurrence.

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The trial randomised 758 patients with breast cancer, with the primary endpoint being disease-free survival (DFS). Galena said the interim analysis was conducted after 70 qualifying DFS events.

Galena said it is also currently conducting two breast cancer studies of NeuVax in combination with Roche’s Herceptin (trastuzumab), and a separate mid-stage trial. The company said it is also planning Phase II trials with NeuVax for gastric cancer.

Anjali Shukla

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