A combination of MEI Pharma’s (MEIP) Pracinostat and the chemotherapy Vidaza (azacitidine) failed to improve remission rates compared to azacitidine alone in patients with Myelodysplastic Syndrome (MDS), said the company on Monday morning.
Pracinostat is a histone deacetylase (HDAC) inhibitor and this trial enrolled 102 patients randomized equally to either arm. The combination showed no difference in the rate of complete remission, the study’s primary endpoint, compared to azacitidine, while duration of response, progression free survival, and overall survival data will require longer followup. The company said that these will be reported at a medical conference later this year.
MEI had planned to begin a phase 3 trial of this combination in 1st-line acute myeloid leukemia (AML) yet this year; however, Monday’s press release suggests that the company will not continue testing a combination until more data are available from the phase 2 trial.
MEI dropped 60% to $2.30 in early trading on Monday, in line with the company’s year-end cash position of about $2.35 per share ($78.7 million in cash/equivalents at December 31, 2014).
