We will have more commentary around the trial design when ethics approval arrives and everything is lockdown. Based on the assumption that ethics is happy with the design of the trial, the 5 doses are designed to start at what should be an effective dose and acheive the max tolerated dose (MTD) on the third dose. It is great having so much historical data around bisantrene that allows us to "guess" this with high accuracy. We saw something similar in the Sheba 2 trial where the MTD was the starting dose making the Phase 1 stage as short as is possible.
The intention of the trial is cardioprotection, not anticancer as in a small trial like this we can disentangle the efficacy of added bisantrene from the efficacy of doxorubicin alone. This means we won't be looking at multi-day dosing per cycle as doxorubicin is not given this way. In a different trial where the aim is anticancer activity multi-day dosing is something I would be very keen for us to explore.
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