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news.An independent committee evaluating the safety, efficacy and futility of Icagen's phase III trial of ICA-17043 for the treatment of sickle cell disease, has recommended that enrollment should continue for patients on concurrent hydroxyurea therapy, but that dosing of patients not taking concurrent hydroxyurea should be stopped.
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For currently enrolled patients not on hydroxyurea, the data monitoring committee (DMC) recommended that dosing with the study drug should be discontinued and that patients proceed to the end of study follow-up period. Approximately half of the patients enrolled in the study to date are not on concurrent hydroxyurea therapy.
The DMC also requested additional data and will reconvene when these are available. No specific safety issues were identified.
“The DMC carefully considered the available data in carrying out their review,” said Dr Seth Hetherington, senior vice president of clinical and regulatory affairs at Icagen. “We have notified the FDA of the recommendations of the DMC, and are implementing these recommendations beginning with notification of the investigators.”
ICA-17043 is a novel small molecule ion channel inhibitor under development for the chronic prophylactic treatment of sickle cell disease. This novel drug candidate is taken orally and is being developed for once-a-day dosing. The drug has received both fast track designation and orphan drug designation from the FDA.