MEDICAL DEVICE INNOVATION - Medical Device Daily

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NovoCure brain cancer device
gets backing from big pharmas
By LYNN YOFFEE
Medical Device Daily Staff Writer
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
MEDICAL DEVICE INNOVATION 2010
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.
(This story originally appeared in the Oct. 15, 2009, edition
of Medical Device Daily)
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