Swiss pharmaceutical group Helsinn and US-based oncology firm MEI Pharma have begun dosing patients in a Phase III clinical trial of pracinostat and azacitidine combination to treat adults with newly diagnosed acute myeloid leukaemia (AML).

Pracinostat is an investigational, oral inhibitor of histone deacetylase (HDAC), while azacitidine is a chemical analogue of a nucleoside called cytidine that is found in DNA and RNA.

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The randomised, double-blind, placebo-controlled Phase III trial is designed to evaluate the combination therapy in up to 500 patients who are aged above 75 and are not suitable to receive standard induction chemotherapy.

The treatment period will be based on 28-day cycles, during which pracinostat will be given three times a week for three weeks and azacitidine will be given for seven days of each cycle, with a one-week no treatment period in between the drug administrations.

"We are very pleased that pracinostat is moving into Phase III, showing the continued momentum of the clinical programme."

The primary endpoint of the trial is overall survival, while the secondary endpoints include morphologic complete remission (CR) rate, event free survival (EFS) and duration of CR.

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Helsinn Group vice-chairman and CEO Riccardo Braglia said: “Helsinn was delighted to be able to announce our strategic partnership with MEI Pharma last year, leveraging on the potential of pracinostat, which was demonstrated in the Phase II study.

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“We are very pleased that pracinostat is moving into Phase III, showing the continued momentum of the clinical programme.”

During the Phase II trial, the combination therapy is reported to have demonstrated a 19.1 median overall survival, 62% one-year survival and 42% CR rate with durable responses.

The combination had received breakthrough therapy designation from the US Food and Drug Administration (FDA) for newly diagnosed AML in patients aged 75 and above.