Icagen has terminated a phase III trial of its treatment for sickle cell disease in adults because of the improbability that it will reach the study goal.
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The decision followed a planned meeting with an independent Data Monitoring Committee which recommended that the trial of the sickle cell drug senicapoc be terminated because of the low probability of achieving a reduction in crisis rate, the primary endpoint.
In making their recommendation, the committee noted that data from the trial indicated the expected increases in hemoglobin and hematocrit and decreases in reticulocytes as well as LDH and bilirubin, both markers of hemolysis.
Among the available data, there were no statistically significant differences in safety measurements between the senicapoc and placebo treatment groups.
The company has informed the FDA of its plan to terminate the study. Icagen said it would still analyze final data and consider future options for the development of senicapoc.
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