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Re: lasers post# 16993

Wednesday, 06/29/2016 2:12:24 PM

Wednesday, June 29, 2016 2:12:24 PM

Post# of 34576
What is simply amazing about NeuVax failure IMO is that after P1 and P2 trials, the FDA approved the 700 persons P3 trial and then recommeded halting by the FDA IDMC due to a large number of failures. Considerable expense $ has neen lost by Galena.

Galena Biopharma Discontinues NeuVax™ (nelipepimut-S) Phase 3, PRESENT Interim Analysis based on Independent Data Monitoring Committee Recommendation
Jun 29, 2016

SAN RAMON, Calif., June 29, 2016 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs, today announced the recommendation from the Independent Data Monitoring Committee (IDMC) on the interim analysis for Galena’s NeuVax™ (nelipepimut-S) Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) clinical trial. On June 27, 2016, the IDMC recommended that the PRESENT trial be stopped due to futility. The letter is attached to the Form 8-K filed today and available on the Company’s website. This planned safety and futility interim analysis was triggered after 70 qualifying disease free survival (DFS) events were reached, and a total of 71 events were reviewed by the IDMC.



http://investors.galenabiopharma.com/investors/press-releases/press-release-details/2016/Galena-Biopharma-Discontinues-NeuVax-nelipepimut-S-Phase-3-PRESENT-Interim-Analysis-based-on-Independent-Data-Monitoring-Committee-Recommendation/default.aspx

These are the only three P2 trials for NeuVax listed on the clinical website

https://clinicaltrials.gov/ct2/results?term=NeuVax+and+Phase2&Search=Search

$TPIV vaccine TPIV100 will no doubt be re-examined by Mayo and $TPIV R&D techs and do a complete detail comparison with NeuVax.

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