Galena Biopharma Inc (NASDAQ:GALE) a biopharmaceutical firm committed to the advancement and commercialization of hematology as well as oncology therapeutics issued the report from a meeting of the DSMB for the two IST combination clinical studies with NeuVax™ plus trastuzumab. The studies are being carried out in breast cancer patients to evaluate the result of the combination of the HER2 vaccine nelipepimut-S and trastuzumab to prevent reappearance in the adjuvant setting.
In light of the initial cessation of the NeuVax Phase 3 PRESENT study last year, the self-determining DSMB executed separate futility evaluations on each of the trastuzumab plus NeuVax combination studies. The DSMB announced that there are no safety issues with either study and neither was identified to be futile.
For the Phase IIb study in subjects with low-to-intermediate HER2 1+/2+, n=242 subjects were assessed, and the approval from the DSMB is to carry on the study with one review to the statistical assessment plan pertaining the timing of the pre-specified provisional assessment.
Considering the lengthy duration of registration for the study, the DSMB decided that the pre-specified provisional efficacy assessment be moved up to 6 months from 12 months after the last subject is enrolled. Closure of enrollment is anticipated in 2Q2017; hence, the DSMB anticipates to perform the provisional efficacy assessment near the end of 2017.
For the Phase II study in high-risk, HER2 3+ subjects, and per the study protocol, the pre-specified provisional safety assessment was also closed on n=50 patients and showed that the agent is taken well with no enhanced cardiotoxicity related with administering NeuVax along with trastuzumab. These results were similar to the data presented last October from the HER2 1+/2+ study. The suggestion from the DSMB is to carry on the HER2 3+ study unmodified.
In the last trading session, the stock price of Galena gained over 17% to close at $1.41.