Cyclacel shares fall as sapacitabine disappoints in Phase III acute myeloid leukemia trial
The announcement that Cyclacel Pharmaceuticals’ (Nasdaq: CYCC) Phase III trial of sapacitabine was unlikely to meet its primary endpoint caused shares in the company to fall as much as 69%.
The drug was being studied for its efficacy in treating patients with acute myeloid leukemia, and a planned interim analysis by the study’s independent data and safety monitoring board said it was "unlikely for the study to reach statistically significant improvement in survival."
The Phase III study, SEAMLESS, was a randomized trial of 486 patients aged 70 years or over with acute myeloid leukemia who were unfit for or have refused intensive chemotherapy. They received oral sapacitabine, alternating with decitabine or decitabine alone, with overall survival set as the primary endpoint.
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