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Trials & Filings

MEI Doses First MDS Patient

Tests pracinostat in patients failing HMA therapy

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

MEI Pharma has dosed the first patient in a Phase II clinical trial of pracinostat, the company’s investigational oral histone deacetylase (HDAC) inhibitor, in patients with myelodysplastic syndrome (MDS) who either failed to respond or maintain a response to a hypomethylating agent (HMA) alone.

The primary objective in the trial is to determine if the addition of pracinostat to Vidaza or Dacogen can improve clinical responses or rescue previous responses achieved with a HMA alone. This two-stage trial is expected to enroll as many as 76 patients into two groups: patients who have had disease progression or have relapsed following a clinical response to either Vidaza or Dacogen therapy, and patients with stable disease who failed to respond to their initial HMA therapy. Preliminary data from this open-label trial is anticipated by December 2014.

The primary endpoint of the trial is clinical improvement rate, defined as the proportion of patients with complete remission (CR), partial remission (PR) and hematologic improvement (HI). Secondary endpoints include overall response rate, CR rate, HI rate, duration of response, progression-free survival, time to progression and overall survival.

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