In parallel with the clinical study program, Clavis Pharma in collaboration with partners are developing an in vitro diagnostic (IVD) method to enable the identification of AML patients with low nucleoside transporter hENT1 expression in blast cells.
The hypothesis is that patients with low hENT1 level will benefit less from cytarabine (current standard therapy) than patients with high hENT1 level and thus benefit from elacytarabine.
Once the association between hENT1 level in blast cells and cytarabine response has been established, a cut-off value for
the definition of hENT1-low expression can be determined.
As elacytarabine is independent of the nucleoside transporter hENT1 for entry into the cell, it is reasoned that newly diagnosed AML patients with low hENT1 level would benefit more from elacytarabine than for cytarabine treatment.
The assay under development will run on flow cytometry systems widely used in haematology laboratories and integrate with standard leukemia diagnostic practice.