PORTSMOUTH, NH December 2 Novocure, a commercial stage private oncology company, has announced that prominent neuro-oncologists at four clinical centers in the U.S. will be the first to provide access to its Tumor Treating Fields (TTFields) device, NovoTTF-100A System, for the treatment of recurrent glioblastoma multiforme (GBM). GBM is a deadly brain tumor affecting approximately 10,000 Americans each year.
The NovoTTF device, approved by the Food and Drug Administration in April 2011, will be available for prescription use in the U.S. initially through several noted brain cancer research centers whose staff have completed training in the use of this unique device. The neuro-oncologists and their centers are:
Novocure expects to train the following clinicians and their staff at the following clinical sites by year end:
"We are pleased to be working closely with these prestigious clinicians and their clinical staff to provide GBM patients with an effective treatment option, and one which does not have the usual debilitating side effects of traditional chemotherapy," said Gabriel Leung, Novocure's Chairman of Global Commercialization. "The clinical staff at these centers have mastered the training and received the certification needed to provide the Novocure TTF therapy to patients. We recognize and appreciate the time and effort dedicated by these individuals to ensure their patients have access to this new treatment."
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. 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 most aggressive and deadly forms of cancer.
TTF therapy, a novel platform technology for the treatment of solid tumors, provides physicians with a fourth treatment modality for cancer in addition to surgery, radiation therapy and chemotherapy.
TTF therapy has been shown in vitro and in vivo to effectively inhibit tumor growth by inducing cell death. TTF takes 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. TTF therapy is delivered using non-invasive, insulated transducer arrays that are placed directly on the skin in the region of the tumor. TTF therapy does not deliver any electric current to the tissue; it does not stimulate nerves or muscles or heat the tissue. 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
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 without many of the side effects of chemotherapy. The most commonly reported side effect from NovoTTF treatment was a mild-to-moderate rash beneath the electrodes. 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.
|Contact: Frank Leonard|
Edelman Public Relations