PORTSMOUTH, N.H., May 29, 2012 /PRNewswire/ -- Novocure™, a commercial stage private oncology company, announced today that data from pre-clinical and clinical studies evaluating NovoTTF™ therapy will be presented and published online as part of the 48th Annual Meeting of the American Society for Clinical Oncology (ASCO) in Chicago, IL, June 1-5, 2012.
The data include the trial design of an ongoing Phase III (IDE) clinical trial of tumor-treating fields (TTFields) together with temozolomide compared to temozolomide (TMZ) alone in patients with newly diagnosed glioblastoma, and experimental data testing TTFields treatment in non-small cell lung cancer and pancreatic cancer.
In addition to these updates, NovoTTF™ therapy will be highlighted at an ASCO Educational Session on Monday, June 4 at 11:30 am in room S406 titled "Glioblastoma: Taking the Standard of Care to the Cutting Edge." The lecture will be presented by Dr. Philip H. Gutin, Chair of the Department of Neurosurgery and Co-Executive Director of the Brain Tumor Center, Memorial Sloan Kettering Cancer Center, New York, New York.
Presenter: Dr. Philip H. Gutin, Memorial Sloan Kettering Cancer Center, New York
Date/Time: Monday, June 4, 11:30 am
Session: ASCO Educational Session
Location: room S406
A future perspective on NovoTTF therapy will be presented as a part of the ASCO Industry Expert Theater on Sunday, June 3 from 11:30 am-12:30 pm in the ASCO Oncology Professionals Hall.
Presenters: Dr. Eilon D. Kirson, Chief Science Officer and Head of Research and Development, Novocure Inc.
Dr. Angela Davies, Chief Medical Officer, Novocure Inc.
Date/Time: Sunday, June 3, 11:30 am – 12:30 pm
Location: ASCO Oncology Professional Hall
Novocure will unveil its ongoing pivotal phase III study, EF14, in newly diagnosed glioblastoma, discussing trial design and rationale at a poster session. The EF14 study is aimed at establishing NovoTTF therapy in the front line setting with current standard of care and is a follow-up to the successful phase III study, EF11, of NovoTTF monotherapy in recurrent glioblastoma.
Presenter: Dr. Santosh Kesari, University of California, San Diego
Date/Time: Saturday, June 2, 1:15 pm – 5:15 pm
Session: Poster, S Hall A2
Several clinical trial and experimental data updates will also be published in conjunction with ASCO 2012 and can be found online at http://abstract.asco.org/:
Principal Author: Dr. Miklos Pless, Kantonsspital, Winterthur, Switzerland
Publication number: e18012
Principal Author: Sze Xian Lee, Beth Israel Deaconess Medical Center, Boston, MA Publication number: e21078
Principal Author: Dr. Moshe Giladi, Novocure Ltd. Haifa, Israel
Publication number: e14616
Glioblastoma (GBM) is the most aggressive and most common form of primary brain tumor in the U.S. The disease affects approximately 10,000 Americans each year. Historically, based on literature, the median overall survival time from initial diagnosis is 15 months with optimal treatment, and median survival from the time of tumor recurrence is only 3-5 months without additional effective treatment. The disease is widely recognized as one of the deadliest forms of cancer.
About the NovoTTF™-100A System
NovoTTF™-100A System is a portable, non-invasive medical device designed for continuous use throughout the day by the patient. The device has been shown in both in vitro and in vivo studies to slow and reverse tumor growth by inhibiting mitosis, the process by which cells divide and replicate. The NovoTTF-100A device, which weighs about six pounds (three kilograms), 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. In patients with recurrent glioblastoma brain tumors, the device has shown clinical efficacy comparable to that of active chemotherapies with better quality of life and without many of the side effects of chemotherapy. The NovoTTF-100A has received marketing approval in the US and is a CE Marked device that is cleared for sale in Europe.
The US Food and Drug Administration (FDA) has approved the NovoTTF™-100A System for use as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM), following histologically – or radiologically-confirmed recurrence in the supra-tentorial region of the brain after receiving chemotherapy. The device is intended to be used as monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
Patients should only use the NovoTTF-100A System under the supervision of a physician properly trained in use of the device. Full prescribing information is available at www.novottftherapy.com or by calling toll free 1-855-281-9301.
Caution: Investigational Device: Limited by U.S. law to investigational use for the treatment of newly diagnosed GBM, lung cancer and pancreatic cancer. The safety and effectiveness of the NovoTTF-100A and NovoTTF-100L for these indications has not been established.
Novocure Limited is a private oncology company dedicated to pioneering the discovery and development of a novel therapy for solid tumors called NovoTTF™ that provides physicians and patients with a simple, predictable and empowering approach to treating solid tumors. Novocure's worldwide headquarters is located in the Jersey Isle. Novocure's U.S. operations are based in Portsmouth, NH and the company's research center is located in Haifa, Israel. For additional information about the company, please visit www.novocure.com
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