MST valuation of RAC, page-7

They are assuming a 140 patient trial for EM R/R AML:

• 40 patients in Australia (and NZ) over 9 sites
• 50 patients in Europe
• 50 patients in the US

Start in Australia first and expand to other locations later (probably next year).

By focusing on EM R/R AML patients (which are normally excluded from AML clinical trials), they will have an edge in recruitment.

They indicate RACE has will start the trial with single-agent Bisantrene for first course of treatment (wording implies multiple cycles) and then switch to Bisantrene in combination with Cytarabrine for the consolidation course (wording implies multiple cycles). The aim is to achieve Measurable Residual Disease (MRD) before bridging to a bone marrow transplant.

This last part about MRD is interesting ... they could do the MRD assay after both the first course of treatment (single agent) and the consolidation course (combination).

That will would give some good data on how Bisantrene performs as a single agent for MRD ... which in theory would provide a dataset for considering the later application of Bisantrene as a front-line therapy.