Novocure™ Receives Humanitarian Use Device Designation for Treatment of Pleural Mesothelioma – Digital Journal


ST. HELIER, Jersey–(Business Wire)–Novocure (NASDAQ:NVCR) announced today that United States Food and Drug
Administration (FDA) has designated it’s Tumor Treating Fields
(TTFields) delivery system as a Humanitarian Use Device (HUD) for the
treatment of pleural mesothelioma.

HUD designation covers devices that treat rare, orphan diseases or
conditions. The HUD designation is the first step in obtaining a
Humanitarian Device Exemption (HDE) for the treatment of pleural
mesothelioma with TTFields. Novocure enrolled the last patient in its
STELLAR trial, a phase 2 pilot trial in pleural mesothelioma, in March
2017 and, with final data collection in 2018, is evaluating its options
to file an HDE application with the STELLAR data. An approved HDE would
allow Novocure to market TTFields in combination with standard of care
chemotherapy as a treatment for pleural mesothelioma in the United

“Due to the clinical and pathological course of mesothelioma, standard
treatment methods rarely lead to a complete cure and new effective
treatments are desperately needed. Our interim data from the STELLAR
trial give us hope that TTFields used in combination with standard of
care chemotherapies may increase survival for patients with mesothelioma
without significantly increasing side effects,” said Dr. Eilon Kirson,
Novocure’s Chief Science Officer and Head of Research and Development.
“We are pleased that the FDA has recognized orphan status for
mesothelioma and acknowledges the urgent demand for new treatment

Novocure’s ongoing STELLAR trial includes 80 patients with unresectable,
previously untreated malignant pleural mesothelioma. STELLAR’s primary
endpoint is overall survival and secondary endpoints are progression
free survival, response rate, and treatment-emergent toxicity. Interim
results presented in December 2016 at the International Association for
the Study of Lung Cancer (IASLC) 17th World Conference on
Lung Cancer suggest improvements in progression free survival and
one-year survival rates when TTFields is added to standard chemotherapy.
Forty-two STELLAR patients who received treatment with TTFields plus
pemetrexed and cisplatin or carboplatin experienced a 12-month survival
rate of 79.7 percent and median progression free survival of 7.3 months.
Median survival had not been reached at the time of presentation due to
limited follow-up time, with an average follow-up time of 11.5 months.
No device-related serious adverse events were reported.

“We believe that treatment with TTFIelds affects fundamental aspects of
cell division and may have broad applicability across a variety of solid
tumors,” said Asaf Danziger, Chief Executive Officer of Novocure. “We
are pleased to receive HUD designation as it is a major step towards a
second regulatory approval for TTFields in the United States.”

Treatment with TTFields is not approved for the treatment of
mesothelioma by the U.S. Food and Drug Administration. The safety and
effectiveness of TTFields therapy for mesothelioma has not been

About Novocure

Novocure is an oncology company developing a profoundly different cancer
treatment utilizing a proprietary therapy called TTFields, the use of
electric fields tuned to specific frequencies to disrupt solid tumor
cancer cell division. Novocure’s commercialized product, Optune, is
approved for the treatment of adult patients with glioblastoma. Novocure
has ongoing or completed clinical trials investigating TTFields in brain
metastases, non-small cell lung cancer, pancreatic cancer, ovarian
cancer and mesothelioma.

Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New
Hampshire, Malvern, Pennsylvania, and New York City. Additionally, the
company has offices in Germany, Switzerland and Japan, and a research
center in Israel. For additional information about the company, please
or follow us at

Forward-Looking Statements

In addition to historical facts or statements of current condition, this
press release may contain forward-looking statements. Forward-looking
statements provide Novocure’s current expectations or forecasts of
future events. These may include statements regarding anticipated
scientific progress on its research programs, development of potential
products, interpretation of clinical results, prospects for regulatory
approval, manufacturing development and capabilities, market prospects
for its products, and other statements regarding matters that are not
historical facts. You may identify some of these forward-looking
statements by the use of words in the statements such as “anticipate,”
“estimate,” “expect,” “project,” “intend,” “plot,” “believe” or other
words and terms of similar meaning. Novocure’s performance and financial
results could differ materially from those reflected in these
forward-looking statements due to general financial, economic,
regulatory and political conditions as well as more specific risks and
uncertainties facing Novocure such as those set forth in its Annual
Report on Form 10-K filed on February 23, 2017, with the U.S. Securities
and Exchange Commission. Given these risks and uncertainties, any or all
of these forward-looking statements may prove to be incorrect.
Therefore, you should not rely on any such factors or forward-looking
statements. Furthermore, Novocure does not intend to update publicly any
forward-looking statement, except as required by law. Any
forward-looking statements herein speak only as of the date hereof. The
Private Securities Litigation Reform Act of 1995 permits this discussion.

Media and Investors:
Ashley Cordova, 212-767-7558

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