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Cyclacel opens enrollment of sapacitabine Phase 3 trial for AML

October 24, 2015

"We chose decitabine as an active control arm as it is one of the treatment options recommended by the National Comprehensive Cancer Network's Clinical Practice Guidelines. We are pleased to learn that this active control arm is acceptable to AML investigators," said Judy Chiao, M.D., Vice President of Clinical Development and Regulatory Affairs of Cyclacel. "AML in the elderly is a life-threatening disease with high unmet medical need. Patients with AML aged 70 years or older have a poor prognosis, as the majority of these patients are not candidates for intensive induction chemotherapy because of poor tolerability to such therapy and a high risk of relapse because of the lack of effective consolidation and maintenance therapy. If the SEAMLESS study is successful, sapacitabine may significantly improve the outcome of this devastating disease in elderly patients."

The treatment regimen of sapacitabine administered in alternating cycles with decitabine has been found to be safe and efficacious in an on-going pilot study conducted at The University of Texas MD Anderson Cancer Center. In addition, SEAMLESS has a lead-in stage to further confirm the safety and efficacy of the alternating treatment regimen in the multicenter setting.

The FDA has designated sapacitabine as an orphan drug for the treatment of both AML and myelodysplastic syndromes (MDS). 

SOURCE Cyclacel Pharmaceuticals, Inc.