Cyclacel Reports On Sapacitabine Program: A Fly In The Ointment?
This article was originally published in The Pink Sheet Daily
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.
You may also be interested in...
Cyclacel Continues AML Trial Of Sapacitabine Despite Futility Analysis
The oncology biotech is plowing ahead with its late-stage study of sapacitabine, despite unfavorable findings during an interim analysis.
Dacogen Leukemia Indication Would Require New Clinical Trial, FDA Tells Eisai
The agency declined to approve decitabine for use in elderly patients with acute myelogenous leukemia because the pivotal study failed to demonstrate a statistically significant survival benefit in the pre-specified primary analysis. FDA’s “complete response” letter tracks with a negative evaluation by the Oncologic Drugs Advisory Committee in February.
Mesoblast’s Late-Stage Pipeline Could Be Game Changing: Are Investors Paying Attention?
Mesenchymal cell specialist Mesoblast came back from a near-death experience in 2016 when Teva returned a key asset. But recent success in a Phase III trial in acute GVHD has brought it some attention. Now it needs to repeat the achievement in advanced heart failure and find a partner for its burgeoning pipeline.