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Phase II Trial Demonstrates Elacytarabine may Increase Survival Threefold in Patients with Late-Stage Leukaemia

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Clavis Pharma ASA has announces positive final results from a Phase II trial of its novel investigational cancer drug, elacytarabine (CP-4055), in patients with late-stage acute myeloid leukaemia (AML).

In the trial, elacytarabine showed statistically significant superior efficacy compared to published clinical data for late-stage AML. Based on these encouraging results an elacytarabine registration study is being planned.

Key results compared to published clinical data: Elacytarabine is a novel cytotoxic agent being developed by Clavis Pharma for the treatment of hematologic cancers and solid tumors, especially those resistant to existing agents.

One particularly difficult-to-treat patient group is late-stage acute myeloid leukaemia (AML) patients who have failed two previous therapeutic regimens. There is currently no standard therapy available for these patients and life expectancy is very short. It is in this patient group that Clavis Pharma has evaluated the safety and efficacy of elacytarabine.

In the Phase II study, 61 patients with late stage AML who failed to respond or relapsed after two separate rounds of treatments received third-line therapy (also called second salvage) with intravenous elacytarabine. The response to treatment was compared with a detailed historical outcome analysis of 594 similar second salvage AML patients, who were treated at the MD Anderson Cancer Center.

Median overall survival in the elacytarabine study was an impressive three times that of the historical control patients (5.5 months vs. 1.5 months). Further follow up on survival is ongoing.