A phase I, first-in-human study of YM155, a small-molecule inhibitor of the anti-apoptosis protein survivin, has indicated that the drug can be safely administered and might have anti-tumour activity.

A range of YM155 doses were administered for 127 cycles to 41 patients who had solid malignancies that were refractory to standard therapy or for whom there was no standard therapy. In general, toxicities were reversible, and severe toxicities were rare. At the maximum tolerated dose (MTD), the plasma concentrations of YM155 exceeded those shown to have anti-tumour activity in preclinical models. Indeed, several tumour responses were observed in patients receiving YM155 at or below the MTD. Of five patients with chemotherapy-refractory non-Hodgkin lymphoma, one complete and two partial responses lasting 8, 24+ and 48+ months were observed. Two of nine patients with hormone-refractory and docetaxel-treated prostate cancer had prostate-specific antigen responses.

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