Published On: Thu, Jun 30th, 2016

Galena Biopharma Inc (NASDAQ:GALE) Falls Following IDMC’s Review of NeuVax Trial

Galena Biopharma Inc (NASDAQ:GALE) has announced that the company has stopped the phase-3 clinical trial of NeuVax, following recommendations from the Independent Data Monitoring Committee. The IDMC conducted and interim analysis of the trials, being conducted by GALE, to recommend that the trials be stopped on account of futility. It should be noted here that the drug achieved a total of 70 qualifying disease free survival events.

The CEO of Galena, Mark W. Schwartz, voiced his disappointment at the result of the analysis. He also thanked the staff and the patients and their families and even lauded their bravery, for participation in the trial. The CEO also revealed that the study is not going to be un-blinded as yet and the company would review the data on its own, prior to making a final decision. Mr. Schwartz also announced to hold a conference call, to provide an update on the path ahead, sometime in the next week.

Following the announcement, shares of GALE plummeted from their closing price on Tuesday, of $2.03. Some analysts had predicted the failure of NeuVax, following its clinical data, filed 4-years ago. It should be noted here that NeuVax was Galena’s most advanced and most important pipeline drug. Analysts also believe that the IDMC’s letter indicates that NeuVax might have even performed worse than the placebo group. However, in its letter, the IDMC disclosed that a re-evaluation of the study was possible, if a systematic reversal in the study drug treatments is observed.

Earlier GALE had made some progress with another one of its pipeline drugs, the GALE-401, which is undergoing five phase-1 trials. The safety data for the drug was presented at the European Hematology Association’s 21st Congress. The drug was found to be well tolerated in patients and could possibly be the next option for GALE, if the NeuVax trial is abandoned.

Galena Biopharma Inc (NASDAQ:GALE) dropped a massive 82.76%, during the June 29 trading session, after having a trade volume of 79.98 million, to close at a share price of $0.350.

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