Antisoma plc announces that the Accede phase III trial of AS1413 (amonafide) in secondary Acute Myeloid Leukaemia (secondary AML) did not meet its primary endpoint. Development of AS1413 will be discontinued.

Glyn Edwards, CEO of Antisoma, said: “We have not seen a benefit with AS1413. 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.”

Antisoma’s pipeline of products comprises: AS1411, a novel aptamer drug with potential in blood cancers and solid tumours; early data from the ongoing phase II b trial in AML show this is likely to be inconclusive, so this trial will be terminated and development will be pursued through other approaches, DCAMs (Dendritic Cell Autoimmune Modulators), a programme of small-molecule kinase inhibitors in preclinical development with potential as oral therapeutics for autoimmune diseases, and PPMID, a new and highly targeted approach to cancer treatment under preclinical development in a collaboration with The Institute of Cancer Research.

As at 31 December 2010, the company had cash resources of approximately £23.4 million. Steps will be taken immediately to reduce expenditure significantly.

Accede was a single pivotal, randomised, controlled trial in which 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). The primary endpoint of the study was the rate of complete remission with or without recovery of normal blood counts.

Antisoma is a London Stock Exchange-listed biopharmaceutical company that develops novel products for the treatment of cancer.