Kura Oncology receives fast track designation for tipifarnib in HRAS mutant HNSCC and provides enrolment guidance for AIM-HN trial

Kura Oncology

16 December 2019 - Registration-directed AIM-HN trial expected to complete enrolment in first quarter of 2021.

Kura Oncology today announced that the U.S. FDA has granted fast track designation to the Company’s lead drug candidate, tipifarnib, for the treatment of patients with HRAS mutant head and neck squamous cell carcinomas (HNSCC) after progression on platinum therapy.

The Company also provided enrolment guidance for AIM-HN, its ongoing registration-directed trial of tipifarnib in patients with recurrent or metastatic HRAS mutant HNSCC. The global, multi-centre trial was initiated in November 2018 and was originally projected to take approximately two years to fully enrol. Based on a recent evaluation of current enrolment rates, the Company now expects the trial to complete enrolment in the first quarter of 2021. The slower pace of enrolment is primarily due to delays in site activation and a higher than anticipated screen failure rate. The trial is now open in more than 81 clinical sites in the U.S., Europe and Asia.

Read Kura Oncology press release

Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Fast track