Shares of Galena Biopharma (GALE) Trade up 22% on 5 Year NeuVax Efficacy Data
Tweet
Share
E-mailGet Alerts GALE Hot Sheet
Join SI Premium – FREE
Shares of Galena Biopharma Inc. (Nasdaq: GALE) are trading up over 22 percent to $0.66 per share following five years wort of data from the ongoing NeuVax Phase 2 trial at the 34th Annual CTRC-AACR San Antonio Breast Cancer Symposium.
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).
"Five years of data is a significant milestone, and NeuVax continues to show a decrease in recurrences for these women with breast cancer who would otherwise have no treatment options to maintain their disease-free state," said Rosemary Mazanet, M.D., Ph.D., Chief Medical Officer of Galena. "Our Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) trial dosing regimen will include the booster inoculations and is expected to commence in the first half of 2012 under an FDA-approved Special Protocol Assessment."
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).
"Five years of data is a significant milestone, and NeuVax continues to show a decrease in recurrences for these women with breast cancer who would otherwise have no treatment options to maintain their disease-free state," said Rosemary Mazanet, M.D., Ph.D., Chief Medical Officer of Galena. "Our Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) trial dosing regimen will include the booster inoculations and is expected to commence in the first half of 2012 under an FDA-approved Special Protocol Assessment."
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Alphabet (GOOGL) soars 16% on Q1 results beat, first-ever dividend
- Western Digital (WDC) posts FQ3 earnings, revenue beat; shares down
- Methanex (MEOH) Appoints Roger Perreault to its Board
Create E-mail Alert Related Categories
Corporate NewsSign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
