Galena Biopharma Inc (NASDAQ:GALE) recently announced the results of its meeting with Data Safety Monitoring Board (DSMB) for its clinical trials associated with NeuVax™ (nelipepimut-S) plus trastuzumab, meant for breast cancer patients. The clinical trial of the company’s latest treatment for breast cancer is being conducted in conjunction with the two investigator-sponsored (IST) combination, NeuVax™ (nelipepimut-S) and trastuzumab.
The new trial focuses on breast cancer patients so as to learn about NeuVax™ (nelipepimut-S)’s ability to perform in combination with trastuzumab and the HER2 vaccine nelipepimut-S. The clinical trials will assess the treatment’s ability to put off recurrence of breast cancer among patients in adjuvant setting.
The clinical run passes safety concerns
An independent futility assessment was performed by DSMB in the backdrop of NeuVax Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVaxTreatment) termination. The board performed its assessment for NeuVax plus trastuzumab combination. After the assessment, the board reported that none of the trials posed any safety concerns. Also, none of these trials can be considered futile.
DSMB said that the interim efficacy analysis shall be performed for the trial by the end of this year, 2017. Meanwhile, the Executive Vice President and Chief Medical Officer of the company, Bijan Nejadnik said, “The recommendations from the DSMB are very positive and the studies were not deemed futile. Given these findings, the trials can continue per the DSMB recommendation.”
IST trials with different methodology
It is important to note that the new combination trial of the company, IST is designed with a different methodology. The design does not include proactive imaging, as done earlier for the PRESENT trial. The new trial, according to company presents potent therapeutic options to avoid recurrence of breast cancer among the patients.
Meanwhile, the company hopes that it shall reach interim efficacy analysis for the Phase 2b HER2 1+/2+ trial before deadline.