Cyclacel Pharmaceuticals (Cyclacel) has reported topline survival data for the primary endpoint of the phase 2 study of sapacitabine. It is intended for the treatment of elderly patients who are aged over 70 years, with either newly diagnosed acute myeloid leukemia (AML) or AML in first relapse.
The study was a three-arm randomized trial evaluating three dosing schedules of sapacitabine. The primary endpoint of one-year survival is approximately 30% each on two out of the three schedules tested. Details of the results from this study will be presented at an upcoming medical conference.
Spiro Rombotis, president and chief executive officer of Cyclacel, said: “We are pleased to report such encouraging survival data from our phase 2 study. The data provide a strong rationale supporting the continued development of this novel agent with a differentiated mechanism of action.
“We are currently working with the FDA to design a Phase 3 registration study for sapacitabine in patients with hematological malignancies. We are concentrating our efforts on advancing sapacitabine into late stage development. In addition we are exploring its potential in solid tumors both as a single agent and in combinations. If Phase 3 trials are successful, sapacitabine could emerge as the first oral drug for the treatment of AML and MDS.”
Survival in elderly patients aged 70 or older with newly diagnosed AML (myeloid leukemia) remains poor. A recent, randomised study comparing tipifarnib, an investigational drug with a different mechanism to sapacitabine, with best supportive care in this population reported 1-year survival of 15% for the tipifarnib arm and 18% for the best supportive care arm, said the company.