Novocure, a privately-held Jersey Isle oncology company, has enrolled the first patients in the EF-21 Study, a prospective randomized clinical study of NovoTTF Therapy for patients with brain metastases from non-small cell lung carcinoma (NSCLC) cancer. NovoTTF Therapy is an anti-mitotic treatment delivered continuously throughout the day by the NovoTTF-100A System.
Eilon Kirson, M.D., Ph.D., Novocure's chief science officer and head of R&D, said, "The study builds on a prior clinical study evaluating the efficacy of the therapy as a treatment for primary NSCLC tumors."
The first patients have been enrolled by Na Homolce Hospital in Prague, Czech Republic and the Medical University Hospital in Vienna, Austria. The EF-21 Study is now open to enrollment at four centers in Austria, Czech Republic, Israel and Italy, and will include centers in Sweden, Poland and Spain.
"Novocure is committed to performing clinical trials across a broad range of solid tumor cancers," said Asaf Danziger, Novocure's CEO.
The EF-21 Study is a multi-center, open-label study designed to test the efficacy, safety and neurocognitive outcomes of NovoTTF Therapy for the treatment of NSCLC patients with controlled systemic disease, following stereotactic radiosurgery for one to five brain metastases. The EF-21 Study is open to enrollment and will recruit 60 patients in Austria, Czech Republic, Israel, Italy, Poland, Spain and Sweden.
NovoTTF Therapy and the NovoTTF-100A System 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 tumor growth by inhibiting mitosis, the process by which cells divide and replicate. The delivery system weighs about six pounds and creates a low intensity, alternating electric field within the tumor that exerts physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death prior to division. NovoTTF Therapy is not approved for the treatment of brain metastases. The safety and effectiveness of the therapy in this indication has not been established.