Cyclacel Continues AML Trial Of Sapacitabine Despite Futility Analysis
This article was originally published in The Pink Sheet Daily
The oncology biotech is plowing ahead with its late-stage study of sapacitabine, despite unfavorable findings during an interim analysis.
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The company will talk to regulators in the US and Europe to see if the drug could be considered in elderly patients with low baseline peripheral white blood cells, who fared better than others in the failed SEAMLESS study.
Cyclacel has made progress on its pivotal trial of lead candidate sapacitabine in AML. But there are questions about its potency as a monotherapy based on an under-reported European trial in which the sapacitabine arm was stopped for futility.
Cancer drugs had a triumphant day at the European Medicines Agency on July 20, led by Pfizer’s Xalkori, with only one (Celgene’s Istodax) failing to make the grade.