Galena (GALE) Reports Statistically Significant Data for NeuVax from Phase 2

December 7, 2011 7:06 AM EST
Galena Biopharma (Nasdaq: GALE), announced five year efficacy data from the ongoing NeuVax Phase 2 trial at the 34th Annual CTRC-AACR San Antonio Breast Cancer Symposium. The event is being held December 6-10, 2011 at the Henry B. Gonzalez Convention Center in San Antonio, Texas.

A presentation entitled, "Long-term clinical benefit of adjuvant breast cancer vaccine: 5 year efficacy of E75 with multiple booster inoculations," was given today during Poster Session 1. The results of the current long-term median follow-up at sixty months showed that the NeuVax (E75 plus GM-CSF) breast cancer vaccine is safe and well–tolerated, and demonstrates efficacy in preventing breast cancer recurrence in optimally-dosed and boosted patients. A total of 187 patients were enrolled in the study, with 108 in the Vaccine Group and 79 in the Control Group. Of the 53 patients who received at least one booster inoculation, a statistically significant disease-free survival rate of 95.9% was seen versus 79.7% in the control group (hazard ratio of 0.20; p=0.016). Several patients remain on study, and Galena estimates reporting final results of the five-year follow-up in the second half of 2012. For the combined intention-to-treat population, including those patients not getting boosters as well as those patients sub-optimally dosed, a strong trend to prevention of recurrence was still observed with the vaccine treated patients demonstrating a disease-free survival rate of 89.4% versus the 79.7% in the control group (hazard ratio of 0.52; p=0.098).


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