First patient enrolled pilot clinical trial of NovoTTF Therapy plus gemcitabine for pancreatic adenocarcinoma

Novocure announced today that the first patient has enrolled in the EF-20 Study, an open label, pilot clinical trial of NovoTTF Therapy plus gemcitabine as first-line therapy for patients with locally advanced and metastatic pancreatic adenocarcinoma. NovoTTF Therapy is an anti-mitotic treatment delivered continuously with a wearable, home-use medical device.

"The EF-20 study builds on extensive preclinical research demonstrating the effectiveness of NovoTTF Therapy alone and in combination with gemcitabine in significantly decreasing tumor burden in animal and human cell pancreatic models," said Uri Weinberg, MD, PhD, Vice President, Research and Development of Novocure. "The study also builds on prior clinical experience safely combining NovoTTF Therapy with chemotherapy for the treatment of glioblastoma and non-small cell lung cancer (NSCLC)."

"We are excited to be the first center to treat a pancreatic cancer patient with NovoTTF Therapy in combination with gemcitabine, as part of the EF-20 clinical trial," said Manuel Benavides, MD, PhD, Head of the Medical Oncology department at the Carlos Haya University Hospital in Malaga, Spain. "NovoTTF has a unique mechanism that acts regionally on the primary tumor and the main sites of metastasis. This anti-mitotic activity could change the course of this devastating disease for many patients."

"Pancreatic cancer is a deadly disease and among the leading causes of cancer-related deaths worldwide. The EF-20 clinical trial will study the safety and preliminary efficacy of NovoTTF Therapy in combination with gemcitabine," said Asaf Danziger, Chief Executive Officer of Novocure. "Novocure is committed to developing NovoTTF Therapy for solid tumor cancers, like pancreatic cancer, with poor prognoses."

The EF-20 Study

The EF-20 Study is an open-label study designed to test the feasibility, safety and preliminary efficacy of NovoTTF Therapy, frequency tuned to 150 kHz, together with gemcitabine for the first-line treatment of locally advanced and metastatic pancreatic adenocarcinoma. The EF-20 Study is open for enrollment and will recruit 20 patients from centers in Spain, Germany and Switzerland. For more information please refer to www.clinicaltrials.gov.

NovoTTF Therapy

NovoTTF Therapy is delivered by a portable, non-invasive medical device designed for continuous use throughout the day by the patient. The device 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 pancreatic adenocarcinoma. The safety and effectiveness of the therapy in this indication has not been established.

Data published in the journal Pancreatology showed that the application of NovoTTF Therapy to pancreatic cancer cells in vitro leads to a significant decrease in cell count and reduced ability to form clones. The efficacy of NovoTTF Therapy was enhanced both in vitro and in vivo when combined with chemotherapy used in the treatment of pancreatic cancer.