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Summary: The press release by biopharmaceutical company Cyclacel Pharmaceuticals is a report on the progress of a Phase II study of sapacitabine, an oral drug that is used to target malignant cells by interfering with DNA synthesis. The ongoing trial is studying patients age 60 and older who have MDS with IPSS scores rated Intermediate-2 or High-Risk and who have failed treatment with Vidaza or Dacogen. In other words, it's a second line of defense for these patients.
Sapacitabine is also being tested in Phase III studies on AML patients.
A Phase II study tests efficacy of a treatment, in this case sapacitabine at 3 dosing schedules. A Phase III study tests a treatment in a head-to-head comparison with another treatment, or in comparison with no treatment.
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