FDA Approves the NovoTTF-100A System for the Treatment of Patients With Recurrent Glioblastoma Multiforme (GBM) Brain Tumors

By Novocure, PRNE
Thursday, April 14, 2011

First ever medical device therapy indicated as an alternative to chemotherapy for cancer

WASHINGTON, April 15, 2011 - Novocure today announced that the U.S. Food and Drug Administration (FDA)
approved the NovoTTF-100A System (NovoTTF) for the treatment of adult
patients with glioblastoma multiforme (GBM) brain tumors, following tumor
recurrence after receiving chemotherapy. The portable, wearable device
delivers an anti-mitotic, anti-cancer therapy as patients maintain their
normal daily activities. The NovoTTF is a novel, first-in-class treatment
option for patients and physicians battling glioblastoma.

(Photo: photos.prnewswire.com/prnh/20110415/CG83483-a)

(Photo: photos.prnewswire.com/prnh/20110415/CG83483-b)

"Our device provides patients and physicians with a novel, non-invasive
alternative to chemotherapy that is safe and effective," said Eilon Kirson,
M.D., Ph.D., Novocure's Chief Medical Officer. "The device allows for
continuous treatment without the usual, debilitating side effects that
chemotherapies inflict on recurrent GBM patients and indirectly on their

Results from a 237 patient randomized pivotal trial demonstrated that
compared to patients treated with chemotherapy, NovoTTF treated patients
achieved comparable median overall survival times, had fewer side effects,
and reported improved quality of life scores.

Glioblastoma is the most aggressive and most common form of primary brain
tumor in the United States. The disease affects approximately 10,000
Americans each year. The median overall survival time from initial diagnosis
is 15 months with optimal therapy, and median survival from the time of tumor
recurrence is only three to four months without additional effective
treatment. The disease is widely recognized as one of the most aggressive and
deadly forms of cancer.

"We move forward from today proud of the efforts and accomplishments of
our team, thankful to our investors for their support and guidance, and
humbled by the trust of our patients and physicians," said Asaf Danziger, CEO
of Novocure. "Our next task is to make NovoTTF therapy available as a
treatment option for all recurrent GBM patients in the U.S."

"The FDA approval of the NovoTTF device is the culmination of ten years
of research, development and clinical trials conducted by an exceptional team
of scientists, engineers, and clinicians and built on the original insights
of our founder and CTO Yoram Palti, M.D., Ph.D.," said William F. Doyle,
Novocure's executive chairman. "We look forward to bringing this device to
recurrent GBM patients and their families, and we look forward to developing
NovoTTF therapy for a range of additional solid tumor cancers."

Pivotal Trial Results

The FDA approval was based on data from a randomized pivotal trial of 237
patients with glioblastoma tumors that had recurred or progressed despite
previous surgical, radiation and chemotherapy treatments. Patients treated
with the NovoTTF alone achieved a comparable overall survival time to
patients treated with the physician's choice of the best chemotherapy. The
rate of progression free survival at six months (PFS6) was 21 percent in the
NovoTTF group compared to 15 percent in chemotherapy patients. Also, patients
treated with the NovoTTF had a 14 percent tumor response rate (RR) compared
to 10 percent in chemotherapy treated patients in the trial, and three
complete radiographic responses were observed in the NovoTTF group compared
to none in chemotherapy patients. NovoTTF treated patients reported better
quality of life scores and fewer side effects during the trial compared to
patients treated with chemotherapy. Specifically, quality of life using the
device was better than that of chemotherapy patients in the following
subscale domains: vomiting, nausea, pain, diarrhea, constipation, cognitive
functioning and emotional functioning, all of which are hallmarks of patient
suffering while receiving chemotherapy. The most commonly reported side
effect from NovoTTF treatment was a mild-to-moderate rash beneath the

The NovoTTF-100A

NovoTTF-100A is a portable, non-invasive medical device designed for
continuous use throughout the day by the patient. The device has been shown
in in vitro studies to slow and reverse tumor growth by inhibiting mitosis,
the process by which cells divide and replicate. The NovoTTF-100A device,
which weighs about six pounds (three kilograms), creates a low intensity,
alternating electric field within the tumor that exerts physical forces on
electrically charged cellular components, preventing the normal mitotic
process and causing cancer cell death prior to division. Novocure currently
has U.S. and European marketing approvals for the NovoTTF-100A.

Ongoing Clinical Studies

Novocure is sponsoring an ongoing pivotal trial of the NovoTTF for
patients with newly diagnosed glioblastoma tumors under an approved
investigational device exemption (IDE) application. For additional
information about this trial, please visit www.novocuretrial.com.

About Novocure

Novocure Limited is a private oncology company pioneering a novel therapy
for solid tumors. Novocure's worldwide headquarters is located in the Jersey
Isle. Novocure's U.S. operations are based in Portsmouth, NH and the
company's research center is located in Haifa, Israel. For additional
information about the company, please visit www.novocure.com.

    Frank Leonard, Novocure
    Phone: +1-917-656-3518


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