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Antisoma Accede trial fails to meet primary endpoint

Antisoma's Accede a single pivotal, randomised, controlled Phase III AS1413 (amonafide) trial failed to meet its primary endpoint in acute myeloid leukaemia (secondary AML).

The primary endpoint of the study was the rate of complete remission with or without recovery of normal blood counts.

In Accede trial, a regimen of AS1413 and cytarabine was compared with standard AML remission-induction therapy of daunorubicin and cytarabine (‘7+3’) in patients with secondary AML (AML following MDS or chemotherapy/radiotherapy treatment of another cancer).

Antisoma CEO Glyn Edwards said they have not seen a benefit with AS1413 and this is hugely disappointing for patients, investigators, investors and employees.

"We will now become smaller and focus on maximising the value of our other programmes," Edwards said.