Clinical Trial for Newly Diagnosed Glioblastoma Opened in Korea
ST. HELIER, Jersey, May 7, 2013 /PRNewswire/ -- Novocure announced today that the EF-14 pivotal clinical trial for patients with newly diagnosed glioblastoma (GBM) brain tumors has enrolled its first patient in Korea. This randomized, controlled trial is designed to enroll approximately 700 patients and will test the efficacy and safety of NovoTTF™ Therapy when added to the current best standard of care 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 tumor growth by inhibiting mitosis, the process by which cells divide and replicate. The device inhibits mitosis by creating 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.
"Newly diagnosed GBM patients in the United States, Europe and Asia may now enroll in the EF-14 Clinical Trial, underscoring Novocure's commitment to providing global access to NovoTTF™ Therapy." said Eilon Kirson, M.D., Ph.D., Novocure's Chief Science Officer and Head of Research and Development, "We look forward to working with our principal investigators in Korea to enroll EF-14."
The EF-14 clinical trial is designed to evaluate potential benefits of NovoTTF Therapy when given as a concurrent therapy with standard of care temozolomide chemotherapy. The trial is currently enrolling patients at more than 70 hospitals around the world, and will include nine centers in Korea. The opening of the trial in Korea followed a full review of the clinical trial protocol and device by the Korea Food and Drug Administration (KFDA).
About 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 vitro and in vivo 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 a tumor 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 United States for patients with newly diagnosed glioblastoma and has not been approved by the FDA for sale in this indication.
Novocure Limited is a private Jersey Isle oncology company pioneering a novel therapy for solid tumors. Novocure's US 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
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