Icagen Ends Study of Treatment for Sickle Cell Disease

Icagen announced that, following a planned meeting of the independent data monitoring committee (DMC) for the company's Phase III ASSERT trial of senicapoc for the treatment of sickle cell disease in adults, the DMC recommended that the trial be terminated because of the low probability of achieving a reduction in crisis rate, the primary endpoint.

In making its recommendation, the DMC 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. Icagen has informed the FDA of its plan to terminate the study. The company will analyze final data when available and consider future options for the development of senicapoc.

At a previous meeting in September 2006, the DMC recommended that the ASSERT trial continue to enroll only those patients who are on concurrent hydroxyurea therapy.

Senicapoc is a small-molecule ion channel inhibitor under development for the chronic prophylactic treatment of sickle cell disease. The drug has received both fast-track designation and orphan drug status from the FDA.