VBI Vaccines announced that the independent data and safety monitoring board, or DSMB, completed its third and final safety assessment of Part A of the ongoing Phase 1/2a clinical study of VBI-1901 in recurrent glioblastoma, or GBM, patients. After reviewing the complete safety data from the fully enrolled, high-dose patient cohort, the DSMB unanimously recommended the continuation of the Phase 1/2a study without modification. Part B of the study, which is expected to enroll a cohort of up to 10 additional patients, will be an extension of the optimal therapeutic dose level from Part A of the study. The company will define the optimal dose following availability of expanded immunologic data and survival data from all three dose cohorts in Part A, which are expected later in the first half of 2019.
https://thefly.com/landingPageNews.php?id=2860869
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