DMC ADVISES ICAGEN'S ICA-17043 TRIAL CONTINUE IN SOME PATIENTS
Icagen announced that, following a recent meeting of the independent data monitoring committee (DMC) of the company's Phase III clinical trial for the treatment of sickle cell disease, the DMC recommended that the ASSERT trial continue its enrollment only of patients on concurrent hydroxyurea therapy. This second meeting followed a review of an updated data set as requested by the DMC at a meeting earlier this year.
"As in the treatment of many diseases, combination therapy may prove to be an effective approach in treating patients with sickle cell disease," said Seth Hetherington, senior vice president of Icagen. "We plan to meet with the FDA in the near future to discuss the implications of the DMC's recommendations on our plans for clinical trials of ICA-17043."
ICA-17043 is a small-molecule ion channel inhibitor under development for the chronic prophylactic treatment of sickle cell disease. The drug is being developed for once-a-day oral dosing. ICA-17043 has received both fast-track designation and orphan drug status from the FDA.