Additional Relevant Details
Launch of the expansion phase follows a poster presentation of preliminary data at the Society for Immunotherapy of Cancer 2015 Annual Meeting, where data from 9 patients showed that AXAL could be safely administered with prophylactic antibiotics up to 1 x1010 CFU, a tenfold increase from prior dosing regimens at 1 x 109. Adverse events at this high dose were consistent with previous experience with predominately grade 1 or grade 2, transient events that self-resolved or were resolved with anti-inflammatory agents (NSAIDS) and antiemetics. The high dose expansion phase will include 15 patients.