Ann: Zantrene AML trial in Israel advances to Phase 2, page-100

@Davisite

I'm hoping you can provide more clarity around this trial for me (and possibly others).

I'm certain you know it in great detail, however here as some screenshots for others -

Announcement date - 27th May 2022







Announcement 7th July 2023 -
" To date, 20 heavily pre-treated patients with relapsed and refractory AML have been enrolled, with only two further patients required to meet the first stage of the Simon two stage decision point"
"Observations in this open label protocol have been compelling, with several patients being effectively bridged to allogenic stem cell transplant with curative intent."

Idon't fully understand the Simon two-stage trial design, but given the fact they have enrolled 20 patients into the trial, would this constitute as a successful trial?

All things being equal, would the response rate in the lead-in stage be a strong indicator of the efficacy stage response rates? Or are they both entirely separate (excluding the obvious of different patients' prognoses, etc).

Cheers