Haifa, Israel - May 29, 2007 - New early data showed that an investigational device that specifically targets rapidly growing cancer cells with intermediate frequency electrical fields -- called Tumor-Treating Fields (TTFields) -- more than doubled the median overall survival rates in patients with recurrent glioblastoma multiforme (GBM), the most common and aggressive type of malignant brain tumor. These survival rates observed in the data were compared to historical data. This research, which includes the results of cell culture, animal and early phase human trials, appears in the current issue of the Proceedings of the National Academy of Sciences (PNAS).
The device, called the Novo-TTF, uses electrical fields to disrupt tumor growth by interfering with cell division of cancerous cells, causing them to stop proliferating and die off instead of dividing and growing. Healthy brain cells rarely divide and have different electrical properties than cancerous brain cells. This allows the device to target cancer cells without affecting the healthy cells.
At the time of publication, researchers found that among the 10 patients with recurring GBM treated with the Novo-TTF, the median length of time to disease progression was 26.1 weeks; progression free survival at six months was 50 percent; and median overall survival was 62.2 weeks. This is more than double the rates reported in historical data - approximately 9.5 weeks, 15.3%, and 29.3 weeks, respectively.
"The novel mechanism of action of the Novo-TTF relies on the physical properties of the cancer cells, their shape and size, rather than the chemical make-up. We believe that this distinction enables the device to stop local proliferation and metastasis of cancer, which would explain the efficacy observed in these early findings," said Dr. Elion Kirson lead author and Vice President of Research and Development, NovoCure. "Based on our preliminary research, we believe that there is a high probability that TTFields may prove to be an effective and safe approach to treating a large number of human cancers."
Based on these positive early findings, patient enrollment has begun for a large-scale phase III clinical trial to further clarify the efficacy and safety of the Novo-TTF in the treatment of recurrent GBM. The research is being conducted at 12 leading cancer centers across the United States, and eight centers in Europe. More information on the trial can be found at www.novocuretrial.com or by calling 800-978-0265.
The single-arm, pilot trial of the safety and efficacy of Novo-TTF treatment was performed on 10 patients for a total of 280 weeks. Efficacy analysis was performed for 10 recurrent GBM patients by comparing time to tumor progression (TTP), progression-free survival (PFS) at 6 months and overall survival (OS) in recurrent GBM patients to these endpoints in historical data.
An unfavorable side effect profile is a major limitation of all current cancer treatments. The ten patients involved in this study received treatment for a total of 280 weeks without a single treatment related adverse event. The only device related side effect seen was a mild to moderate contact dermatitis beneath the field delivering electrodes, which responded well to the application of topical cream and periodic electrode relocation.
The Novo-TTF is a non-invasive medical device developed by NovoCure Ltd. that is currently being evaluated in a Phase III clinical trial for the treatment of recurrent glioblastoma multiforme (GBM). The device 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.
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 treating cancer with electrical fields. In addition to Professor Palti, NovoCure has assembled a world class team of experts who have spent their entire careers inventing, building, or commercializing innovative medical products. Please visit our website to see the biographies for NovoCure's team (www.novocuretrial.com/about.html).