First patient enrolled in EF-14 trial in South Korea
Novocure's EF-14 pivotal trial for patients with newly-diagnosed glioblastoma (GBM) brain tumours has enrolled its first patient in South Korea. This randomised, controlled trial is designed to enrol approximately 700 patients and will test the efficacy and safety of the company's NovoTTF therapy when added to the current best standard-of-care, temozolomide chemotherapy, for newly-diagnosed GBM.
NovoTTF therapy is delivered by a portable, non-invasive medical device designed for continuous use throughout the day by the patient. The device, the NovoTTF-100A system, has been shown in in vitro and in vivo studies to slow and reverse tumour growth by inhibiting mitosis. The delivery system weighs approximately 6lbs and creates a low-intensity, alternating electric field within a tumour that exerts physical forces on electrically-charged cellular components, preventing the normal mitotic process and causing cancer cell death prior to division. The device is an investigational device in the US for patients with newly-diagnosed GBM and has not been approved by the FDA for sale in this indication.
The trial is currently enrolling patients at more than 70 hospitals around the world, and will include nine centres in South Korea. The opening of the trial in South Korea followed a full review of the trial protocol and device by the South Korean FDA.