A total of 17 patients were enrolled for the Phase I study. Asymptomatic hypokalemia was the only dose limiting toxicity (DLT) observed. Analysis of the data showed an increase in pharmacodynamic activities as demonstrated by increase in the activities of natural killer, CD8 and type II dendritic cells.
Edward Bradley, chief scientific officer, said: “The increased function in T, NK, and dendritic cell populations at a dose that is well tolerated is exactly what we had hoped to see in this Phase I trial, and we look forward to the Phase IIa program which is now ready to enroll patients.”