Galena Biopharma (Nasdaq: GALE) shares rocketed more than 100% to $2.41 in pre-market trading, after the company announced that its independent experts had approved continuation of clinical trials of its breast cancer vaccine. The stock was still up 48.8% at $1.79 in mid-morning activity.
In a reversal of fortunes, the company today announced the results from a meeting of the Data Safety Monitoring Board (DSMB) for the two investigator-sponsored (IST) combination clinical trials with NeuVax (nelipepimut-S) plus trastuzumab. The trials are being run in breast cancer patients to assess the ability of the combination of trastuzumab and the HER2 vaccine nelipepimut-S (administered with the immunoadjuvant granulocyte macrophage-colony stimulating factor) to prevent recurrence in the adjuvant setting.
Last June Galena’s shares tanked after it revealed that its most advanced pipeline product, cancer vaccine NeuVax, had failed in a Phase III study, and its Independent Data Monitoring Committee recommended that the PRESENT trial be stopped due to futility.
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