Medical Device Daily National Editor

Sen. Ted Kennedy is battling it, along with thousands of others without famous names. Those with glioblastoma multiforme (GBM) brain cancer have almost no hope of cure, only something that will extend the weeks and months left to them.

Working to extend that time to years is NovoCure (Haifiz, Israel).

The company reported "current" data, one might say, at the recent meeting of the Society of Neuro-Oncology (SNO; Bellaire, Texas), demonstrating the ability of its electricity-generating device to increase the efficacy of chemotherapy for treating brain cancer.

The company's Novo-TTF (tumor-treating field) device, in both a pilot clinical trial and an in vitro study, was used in conjunction with chemotherapy (using the drug temozolomide), enhancing that treatment in newly-diagnosed patients with GBM.

The Novo-TTF-100A device uses electric fields for extending patient survival, by improving the anti-tumor effects of chemotherapy.

Mike Ambrogi, U.S. general manager for NovaCure, noted that there are a number of device systems for oncology diagnosis and initial treatment, but few devices offering "ongoing chronic treatment of cancer."

Thus, the Novo-TTF offers "a new paradigm for treating solid tumors," he told Medical Device Daily, and offering a unique opportunity both for patients and the company.

For these patients, there are "not a lot of options," he said, with survival frequently no more than two years, even with the best therapies.

The device delivers electric energy through four sets of insulated electrodes — described as looking somewhat like bandages — embedded in a cap placed over the patient's scalp. The TTFields pass through the scalp to the tumor site, with the cap tethered to a battery-powered control unit, called a TTField-generating box.

Weighing just 6 pounds, the box is carried by the patient in a case looking like an over-the-shoulder satchel, allowing freedom of movement, with the company promoting the advantage of its being non-invasive.

The patient wears the device continuously – though it is removable for brief personal care – for as long as the disease is stable or regressing, and NovoCure provides 24/7 technical support.

Ambrogi said the main therapeutic target is as an adjunct to chemotherapy, not to supplant it, though it might find standalone use where patients cannot tolerate other therapies.

Reported at the SNO meeting was data from one arm of a two-armed study of 10 patients evaluating efficacy/safety of the device in combination with chemotherapy (employing the drug temozolomide) in 10 patients with newly diagnosed GBM. The results of the study were compared to historical control outcomes of chemotherapy when given alone.

The patients received Novo-TTF treatment for up to 18 months, with feasibility, toxicity, time to disease progression and overall survival the main endpoints.

Median time to disease progression was 155 weeks in patients treated with combined chemotherapy and the Novo-TTF, compared to 31 weeks in control patients treated with chemotherapy alone. Half of patients were still progression-free at the end of the trial, according to the company.

Median overall survival was greater than 40 months in the combination of two arms, compared to 14.7 months reported for historical controls. Eight of the 10 patients were still alive at the end of this study.

Also presented at SNO was data from the in vitro study, using both treatments together on GMB cells in culture, that data mirroring pilot study results.

NovoCure also is conducting a Phase III clinical trial of 236 patients at more than 20 centers in the U.S. and Europe for treatment of recurrent GBM, and Ambrogi told MDD that the company has completed enrollment of 200 patients.

Half of trial enrollees receive the Novo-TTF treatment, the other half receive what the company terms "the most advanced glioblastoma treatments currently practiced as the best standard of care ..."

He said that the company hopes to complete this trial in 1Q09, do a six-month follow-up of patients and, it is hoped, file for FDA clearance before the year is out.

Best-case scenario, he said – though also noting the unpredictability of FDA action – would see product commercialization in 2010.

According to the company, the electric current – described as "low-intensity, intermediate-frequency, alternating fields" – delivered to the tumor slows its growth by disrupting the proliferation of the cancer cells.

TTFields, NovaCure says, cause the cancer cells to pile up and break apart as they multiply. Additionally, the particular type of electric charge being used damages and interrupts the polar structures that produce electrical activity within the cell as it attempts to divide, it says.

The device produces a slight warming of the scalp but the only adverse effect is an occasional mild irritation at the electrode sites.

Importantly, the company said that in pre-clinical and clinical studies to date, the electric fields have shown no injury to slower-dividing healthy cells, indicating the ability to treat the cancer without harming surrounding tissue.

In other activity:

• NovaCure said it plans to launch a Phase III clinical trial in 2009 evaluating the treatment in combination with standard chemotherapy in patients with newly diagnosed GBM.

• The company also is doing clinical studies with limited numbers of patients for breast and lung cancers. In these applications, larger electrodes are embedded in material wrapped around the chest or breasts.

• The company in December 2007 received the CE mark for the device for use in treating recurrent and newly diagnosed GBM. But rather than pursuing commercialization in European markets, the company is putting its focus, Ambrogi said, on the development of robust data that it can take to the FDA and the Centers for Medicare & Medicaid Services. He said the firm is analyzing various "scenarios" concerning how to approach CMS and the establishment of pricing.

NovoCure is venture-backed, with Ambrogi characterizing the company as "very well funded – I don''t see [financing] as a problem at the moment."

The company was founded by Professor Yoram Palti, MD, PhD, in 2000 to build on his research in electrophysiology and biomedical engineering, focused on electrical fields to treat cancer. Palti is a professor of physiology and biophysics at the Technion–Israel Institute of Technology (Haifa) and formerly an associate professor of physiology at the University of Maryland School of Medicine (Baltimore).