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NOVEL DEVICE SHOWN TO BENEFIT SURVIVAL FOR BRAIN CANCER
PATIENTS WHEN COMBINED WITH CHEMOTHERAPY
Israel – January 22, 2009 – Newly published data show that the Novo-TTF device combined with standard chemotherapy (temozolomide) demonstrated a three-fold increase in time to progression (TTP) and a five-fold increase in overall survival (OS) for patients with newly diagnosed glioblastoma multiforme (GBM), when compared to historical controls. This study of the Novo-TTF, a non-invasive medical device that uses low intensity alternating electric fields to destroy cancer cells was published in BMC Medical Physics in January.
In the pilot trial, 10 patients with newly diagnosed GBM were treated with combination therapy of standard chemotherapy and the Novo-TTF device. The study showed that combination therapy prolonged TTP by nearly 30 months and increased survival by more than 25 months compared to historical results of patients receiving standard chemotherapy alone. According to updated pilot data recently presented at the annual Society for Neuro-Oncology meeting late last year, eight of the 10 patients were still alive 49 months after the study began. Patients in the study did not experience any device-related, systemic, adverse events.
“We are excited about the publication of these pilot study results as they indicate the potential effect the Novo-TTF device may have on chemotherapy in the treatment of newly diagnosed GBM,” said Eilon Kirson, MD, Medical Director, NovoCure Ltd. “many patients with GBM do not live beyond 12 months on standard therapy, but these data show that the Novo-TTF device combined with chemotherapy may enhance its efficacy and lead to much longer survival.”
The study also included an initial In vitro study that showed the Novo-TTF device enhanced the efficacy of standard chemotherapy (temozolomide) treatment when applying both treatments together to GBM cells in culture. Data from these studies were recently presented during the annual Society for Neuro-Oncology meeting in November 2008.
The Novo-TTF device disrupts cancer cell proliferation and tumor growth by generating low intensity, intermediate frequency, alternating electric fields within a tumor. These electric fields exert forces on polar structures within the dividing cancer cells that prevent tumor growth. In pre-clinical and clinical studies to date, the electric fields have shown no effect on non-dividing, healthy cells in the same region, suggesting that the device can treat cancer without harming surrounding tissue, unlike chemotherapies that are typically associated with high toxicity resulting in serious side effects. The Novo-TTF is currently an investigational medical device and is not yet FDA approved.
NovoCure recently published data from its human pilot study for patients with later stage GBM tumors that recurred after surgery and radiation. The results of this study preliminarily indicate that the Novo-TTF more than doubled the median overall survival rates for recurrent GBM patients relative to historical data.
NovoCure is currently conducting a Phase III clinical trial at more than 20 centers in the US and Europe for patients with recurrent GBM and is planning to launch a Phase III clinical trial to evaluate Novo-TTF treatment in combination with standard chemotherapy in patients with newly diagnosed GBM in 2009. Please refer to www.novocuretrial.com or call 1 (800) 978-0265 for more information on the ongoing trial.
STUDY DETAILS
The in vitro study looked at the effects of TTFields alone and in combination with DTIC, a precursor of MTIC (the active metabolite of temozolomide) in human GBM cells. The results demonstrated that, when applied together with DTIC, TTFields drastically increased the sensitivity of GBM cells in culture to DTIC.
The open-label, single-arm prospective pilot clinical trial evaluated the efficacy and safety of the Novo-TTF device in combination with standard chemotherapy (temozolomide). Twenty patients were enrolled in the trial, 10 patients with newly diagnosed GBM were treated with combination therapy and 10 patients with recurrent GBM were treated with the device alone as salvage therapy. The results of the study were compared to concurrent and historical control outcomes of standard chemotherapy when given alone. All patients were followed on a monthly basis and received treatment with the device for up to 18 months. The primary endpoints were feasibility, toxicity, time to disease progression and overall survival. No device-related, systemic, adverse events were noted throughout treatment with the Novo-TTF device. A mild to moderate skin irritation appeared beneath the device electrodes in all patients.
Median time to disease progression was 155 weeks in the 10 patients treated with combined standard chemotherapy and the Novo-TTF device, compared to 31 weeks in concurrent control patients treated with standard chemotherapy alone. Half of patients were still progression-free at the end of the trial. Median overall survival was reported at 39 months at the time of publication and was recently updated by the company to be greater than 49 months in the combination trial, compared to 14.7 months reported for historical controls.
ABOUT NOVO-TTF
The Novo-TTF, developed by NovoCure Ltd., is a portable non-invasive medical device that disrupts the division of cancer cells in the brain using alternating electrical fields delivered by means of insulated electrodes applied to the surface of the scalp. The electrodes look like bandages with wires attached. The device is powered by a small lightweight battery pack. Patients carry the Novo-TTF device in a specialized over-the-shoulder bag and receive continuous treatment without changing their daily routine.
ABOUT NOVOCURE
NovoCure Ltd. is a private company dedicated to developing innovative cancer treatments. Professor Yoram Palti, M.D., Ph.D. founded NovoCure in 2000 to develop his research in electrical fields as a treatment for cancer. Please visit our website to learn more (www.novocuretrial.com).
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