Novocure™ Enrolls First Patient in a Pilot Study of Tumor Treating Fields (TTFields) Together with Paclitaxel for the Treatment of Recurrent Ovarian Cancer
Trial will test the potential synergy between a taxane and TTFields in the treatment of recurrent ovarian cancer
ST. HELIER, Jersey, Oct. 30, 2014 /PRNewswire/ -- Novocure announced today that the first patient has been enrolled in the INNOVATE study, an open-label pilot clinical study of TTFields together with weekly paclitaxel for patients with recurrent ovarian cancer.
"The INNOVATE study builds on published preclinical research that shows clear synergy between TTFields and taxanes in different human and animal cancer models, including ovarian cancer," said Uri Weinberg, MD, PhD, Vice President, Research and Development at Novocure. "The study also builds on prior clinical experience of safely combining TTFields with chemotherapy in glioblastoma, pancreatic adenocarcinoma and non-small cell lung cancer."
"We are very happy to be the first center to treat an ovarian cancer patient with TTFields in combination with weekly paclitaxel as part of this clinical trial," said Luis Manso, MD, Medical Oncologist at the 12 de Octubre Hospital in Madrid, Spain. "As a regional treatment, we believe TTFields therapy has the potential to change the course of this locally spreading disease, by exerting its anti-mitotic effect within the entire peritoneal cavity. The potential for clinical synergism with paclitaxel and the expected low toxicity profile of TTFields in the abdomen, make this an exciting and experimental approach to treating ovarian cancer".
"The majority of women with ovarian cancer are diagnosed at an advanced stage, and many suffer from the severe side effects of multiple lines of chemotherapy. Through this pilot study, we hope to understand the safety and preliminary efficacy of TTFields in combination with a chemotherapy regimen," said Asaf Danziger, Chief Executive Officer of Novocure. "Novocure is committed to developing TTFields as a low toxicity, effective therapy for multiple solid tumor cancers."
INNOVATE
INNOVATE is an open-label pilot clinical study designed to test the feasibility, safety and preliminary efficacy of TTFields therapy together with weekly paclitaxel for the treatment of recurrent ovarian carcinoma. INNOVATE is anticipated to enroll 30 patients from Spain, Germany, Belgium and Switzerland. For more information please refer to www.clinicaltrials.gov.
About Ovarian Cancer
Ovarian cancer is the leading cause of mortality among gynecologic malignancies and the fifth most common cause of cancer death in women in the United States. Each year, approximately 250,000 women worldwide are diagnosed with ovarian cancer and 140,000 die from the disease. Ovarian cancer incidence increases with age and the median age at time of diagnosis is 63 years. The 5-year survival rate is 44% and the majority of patients present at advanced stage with 61% having metastatic disease.
Tumor Treating Fields (TTFields)
TTFields 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. TTFields are not approved for the treatment of ovarian cancer. The safety and effectiveness of TTFields in this indication has not been established.
About Novocure
Novocure Limited is a private Jersey Isle oncology company pioneering a novel therapy for solid tumors. Novocure's United States 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.
Media Contact:
Peter Melnyk, Novocure
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(212) 767-7534
Investor Contact:
Ashley Cordova, Novocure
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(212) 767-7558
SOURCE Novocure
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