Privately held NovoCure (Haifa, Israel) is taking its cancer treatment device into a pivotal trial – squaring off against one of the most aggressive cancers: glioblastoma multiforme (GBM), the brain cancer that generally kills its victims in about a year.
Apparently the early data are so promising that some heavyweight backers are now on board. The company just reported completing a new funding round with investors Pfizer (New York), Johnson & Johnson (New Brunswick, New Jersey) and Index Ventures.
"We're very happy to have them on our team of investors," Mike Ambrogi, U.S. general manager for NovaCure, told Medical Device Daily. "Prior to this fundraising round they weren't involved. Both companies have vast experience and we look forward to their input, but they are not directly involved in R&D. But we have the opportunity to draw upon their counsel."
NovoCure's pilot study in Europe, which was the basis for its investigational device exemption approval, included 10 patients, of whom seven are still alive today, five years out.
"If all of the patients were to expire now, we would have median overall survival of 62 months vs. 14.6 months for temozolomide (chemotherapy) alone," Ambrogi said. "We continue to follow these patients and they continue to live. Five of 10 are progression free, meaning there's been no recurrence and they aren't on any treatment of any kind."
Although the amount of the investment that came from the pharma giants was undisclosed, Ambrogi said it's enough to get the company's promising treatment through trials and, if all goes well, into commercialization.
The Novo-TTF device aims to zap solid tumors via specially tuned, low-intensity electrical fields known as tumor treating fields (TTF) to disrupt cell division. Rapidly dividing cancer cells are either broken apart or fail to divide properly when attacked by these electrical fields. Healthy surrounding cells aren't affected, yielding a targeted treatment with minimal side effects.
"To date, the only known side effect is a reddening of skin, dermatitis, where the electrodes are attached, which is to be understood, given that it's warm and moist," Ambrogi said. "Other than that, no adverse events have been attributed to the device."
The patient wears a cap on the scalp that's embedded with non-invasive, insulated electrodes. Those electrodes, which look like bandages, are attached by wires to a battery operated, six-pound portable device – carried in an over-the-shoulder satchel – that generates the fields. Patients wear the cap for up to 24 hours a day
In the new 283-patient trial, investigators will study the efficacy of the Novo-TTF device for newly diagnosed GBM patients in combination with standard-of-care chemotherapy, temozolomide (made by Schering-Plough [Kenilworth, New Jersey]), compared with chemotherapy alone in patients with newly-diagnosed GBM. Two-thirds of the patients will receive treatment with the Novo-TTF device while the rest will receive only chemotherapy.
"The primary endpoint is progression-free survival time," Ambrogi said. "We are also expecting to show overall survival benefit."
Study centers are now enrolling patients in the U.S., Europe and Israel. The trial is expected to last two years with a one-year follow-up. If all goes well, the company will be ready for a PMA submission in 2012.
NovoCure also recently completed enrollment for a 236-patient, multi-center, randomized pivotal trial studying the safety and efficacy of the Novo-TTF device treating patients with recurrent GBM compared to standard-of-care chemotherapy. Ambrogi pointed out that patients with newly diagnosed and recurrent GBM are treated quite differently, hence the separate trials. The results of this trial will be presented to the FDA as part of a PMA application planned for early next year.
"The way the tumor reacts is different in newly diagnosed GBM vs. recurrent," he pointed out. "Typically newly diagnosed patients have minimal disease. In recurrent cases the tumor is potentially more aggressive and responds differently to treatment."
The company's device was invented by NovoCure's founder, Yoram Palti, MD, PhD, who began testing the technology in the basement of his home more than a decade ago. "He theorized how it could work and then verified it in the lab," Ambrogi said. "We believe it's a pretty strong platform."
That platform, he added, will be applicable to other cancers too. A small trial – 42 patients with non-small cell lung cancer is currently being conducted in Switzerland.
"These are late-stage patients who failed first-line treatment," Ambrogi said. "We're seeing some promising early results."
But the company is focused on the GBM indication right now. "We started on brain cancer because it's a pretty tall hurdle. Patients don't have a lot of options. The prognosis for a GBM patient is fairly dire and we think we can have a pretty significant impact. We believe we can be successful and make a big difference to these particular patients," he said.
Ambrogi said he is not aware of any other company developing a device that uses alternating electric fields to arrest cell growth, making NovoCure a pioneer in this approach to cancer treatment.
—Compiled by Lynn Yoffee, MDD Writer