HAIFA, Israel, Nov. 19, 2013 /PRNewswire/ -- Novocure announced today that the first patients have enrolled 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.
"The EF-21 Study builds on extensive preclinical research on the effect of NovoTTF Therapy in preventing cancer from metastasizing to the brain in animal models," said Eilon Kirson, M.D., Ph.D., Novocure's Chief Science Officer and Head of Research and Development. "The study also 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 Chief Executive Officer. "We look forward to working with our EF-21 Study investigators to evaluate NovoTTF Therapy as a treatment for patients with brain tumors from metastatic lung cancer."
The EF-21 Study
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. For more information please refer to http://www.clinicaltrials.gov/ct2/show/NCT01755624.
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.
Novocure Limited is a private Jersey Isle oncology company pioneering a novel therapy for solid tumors. Novocure's U.S. operations are based in New York, NY and Portsmouth, NH and the company's research center is located in Haifa, Israel. For additional information about the company, please visit www.novocure.com.
Frank Leonard, Novocure