By June 1, a total of 15 clinical centers in the U.S. will be certified to use the NovoTTF™-100A System to treat patients with recurrent glioblastoma multiforme (GBM).
PORTSMOUTH, N.H., May 25, 2012 /PRNewswire-Asia/ -- Novocure™, a commercial stage private oncology company, announced that by June 1, eight additional clinical centers of excellence will join the seven existing clinical centers that provide Novocure's Tumor Treating Fields (TTFields) therapy to patients with recurrent GBM. These fifteen clinical centers are among the leading cancer centers in the U.S.
GBM is both the deadliest and most common form of primary brain tumor in the U.S., diagnosed in approximately 10,000 Americans each year. Based on the literature, the median overall survival time from initial diagnosis for patients with GBM 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.
The NovoTTF-100A™ device was approved by the U.S. Food and Drug Administration (FDA) in 2011 for the treatment of recurrent GBM. It is available in the U.S. for prescription use from centers whose clinical staff has been trained in the use of the system.
The additional clinical centers and their contacts are:
These eight new clinical centers join the seven existing centers where NovoTTF therapy has been available for recurrent GBM patients since the end of last year:
"As we continue to expand the number of clinical centers where NovoTTF therapy is provided, including some of the most prestigious cancer centers in the world, our hope is that more patients can be helped with this effective treatment option which does not have the debilitating side effects seen with traditional chemotherapy," said Gabe Leung, Chairman of Global Commercialization. "As more physicians gain clinical experience with NovoTTF therapy, we believe it will take its place as a standard of care for this difficult to treat disease."
TTFields therapy, a novel platform technology for the treatment of solid tumors, provides physicians with a fourth treatment modality for recurrent GBM in addition to surgery, radiation therapy and chemotherapy.
TTFields therapy has been shown in vitro and in vivo to effectively inhibit tumor growth by inducing cell death. TTFields take advantage of the electrical characteristics, geometrical shape and replication rate of dividing cancer cells - all of which makes them susceptible to the effects of alternating electric fields. The therapy is delivered via non-invasive, insulated transducer arrays that are placed directly on the skin in the region of the tumor. TTFields therapy is frequency-tuned to target cancer cells and avoid harming normal cells. It creates an artificial, alternating electric field within the tumor which disrupts cancer cell division and can cause complete destruction of the dividing cancer cells.
About the NovoTTF-100A System
The 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 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 most commonly reported side effect from NovoTTF-100A treatment was a mild-to-moderate rash beneath the transducer arrays. The NovoTTF-100A has received marketing approval in the U.S. 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.
About Novocure
Novocure Limited is a private oncology company pioneering a novel therapy for 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
Media contacts:
Peter Melnyk
Pmelnyk@novocure.com
(631) 697-7457
Frank Leonard
Fleonard@novocure.com
(215) 854-4095
