This trial is the first to study Optune in combination with an
investigational drug
Novocure (NASDAQ:NVCR) announced today a new arm for a phase 1b
study to evaluate the safety of marizomib and temozolomide in
combination with Optune, Novocure’s Tumor Treating Fields
(TTFields) delivery system, as adjuvant treatment for patients with
newly diagnosed glioblastoma (GBM) following radiation therapy with
concurrent temozolomide. The trial is the first to study Optune in
combination with an investigational drug.
Marizomib is a novel, brain-penetrant proteasome inhibitor
developed by Triphase Accelerator Corporation and acquired by
Celgene Corporation. Celgene is responsible for marizomib’s
development.
“This collaboration marks an important first step toward testing
Optune with a promising new investigational compound for the
treatment of GBM,” said Principal Investigator Dr. Roger Stupp,
Associate Director for Strategic Initiatives at the Robert H. Lurie
Comprehensive Cancer Center of Northwestern University. “Optune is
the first treatment in over a decade to improve survival in GBM. I
believe that combining Optune with new pharmacologic treatments in
clinical trials, like this phase 1b study, will help advance our
understanding of how to treat this devastating disease.”
Celgene and Triphase modified their current phase 1b
multicenter, open-label study of marizomib in combination with
temozolomide and radiotherapy in patients with grade IV malignant
gliomas to include Optune. A cohort of 12 GBM patients will be
treated with Optune in combination with marizomib and temozolomide
after initial treatment with radiation and temozolomide has been
completed.
The primary objective for the Optune portion of the study is to
determine the safety of the combination of marizomib and
temozolomide with the addition of Optune in patients entering the
adjuvant treatment phase. Secondary objectives for the Optune
portion of the study include assessing preliminary clinical
activity of the combination of Optune, marizomib and temozolomide
in patients entering adjuvant therapy, progression-free survival
and overall survival. The protocol has been submitted to an
institutional review board, and this arm of the trial is expected
to open in the third quarter of 2017.
“We believe TTFields has the potential to be an excellent
development candidate in combination with other solid tumor cancer
treatments,” said Dr. Eilon Kirson, Novocure’s Chief Science
Officer and Head of Research and Development. “As innovators in
cancer treatment, we know collaboration is essential to improve
patient outcomes. We hope this is the first collaboration of
many.”
Tumor Treating Fields in combination with temozolomide and
marizomib is experimental for the treatment of glioblastoma.
Limited by law to investigational use only.
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,
Japan and Israel. For additional information about the company,
please visit www.novocure.com or follow us at
www.twitter.com/novocure.
About Optune
In the United States, Optune is intended as a treatment for
adult patients (22 years of age or older) with
histologically-confirmed glioblastoma multiforme (GBM).
In the United States, Optune with temozolomide is indicated for
the treatment of adult patients with newly diagnosed,
supratentorial glioblastoma following maximal debulking surgery and
completion of radiation therapy together with concomitant standard
of care chemotherapy.
In the United States, for the treatment of recurrent GBM, Optune
is indicated following histologically-or radiologically-confirmed
recurrence in the supratentorial region of the brain after
receiving chemotherapy. The device is intended to be used as a
monotherapy, and is intended as an alternative to standard medical
therapy for GBM after surgical and radiation options have been
exhausted.
Important Safety Information
Contraindications: Do not use Optune if you have an
active implanted medical device, a skull defect (such as, missing
bone with no replacement), or bullet fragments. Use of Optune
together with implanted electronic devices has not been tested and
may theoretically lead to malfunctioning of the implanted device.
Use of Optune together with skull defects or bullet fragments has
not been tested and may possibly lead to tissue damage or render
Optune ineffective.
Do not use Optune if you are known to be sensitive to conductive
hydrogels. In this case, skin contact with the gel used with Optune
may commonly cause increased redness and itching, and rarely may
even lead to severe allergic reactions such as shock and
respiratory failure.
Warnings and Precautions: Use Optune only after receiving
training from qualified personnel, such as your doctor, a nurse, or
other medical personnel who have completed a training course given
by Novocure (the device manufacturer).
Do not use Optune if you are pregnant, you think you might be
pregnant or are trying to get pregnant. It is not known if Optune
is safe or effective in these populations.
The most common (≥10%) adverse events involving Optune in
combination with temozolomide were low blood platelet count,
nausea, constipation, vomiting, fatigue, scalp irritation from
device use, headache, convulsions, and depression.
The most common (≥10%) adverse events seen when using Optune
alone were scalp irritation from device use and headache.
The following adverse reactions were considered related to
Optune when using the device alone: scalp irritation from device
use, headache, malaise, muscle twitching, fall and skin ulcer.
All servicing procedures must be performed by qualified and
trained personnel.
Do not use any parts that do not come with the Optune Treatment
Kit, or that were not sent to you by the device manufacturer or
given to you by your doctor.
Do not wet the device or transducer arrays.
If you have an underlying serious skin condition on the scalp,
discuss with your doctor whether this may prevent or temporarily
interfere with Optune treatment.
Please see http://www.optune.com/safety to see the Optune
Instructions For Use (IFU) for complete information regarding the
device’s indications, contraindications, warnings, and
precautions.
About Marizomib
Marizomib is an investigational, proteasome inhibitor initially
developed by Triphase Accelerator Corporation and now owned by
Celgene Corporation. Marizomib has been shown to irreversibly bind
to all three proteasome subunits (β5 chymotrypsin-like, β2
trypsin-like, and β1 caspase-like). In early clinical trials,
marizomib has demonstrated brain penetration activity. Marizomib is
being developed in both intravenous (IV) and in early oral
formulations as a potential proteasome inhibitor for hematologic
malignancies and solid tumors. The IV formulation has been
evaluated in more than 390 patients in multiple clinical studies in
patients with solid and hematologic malignancies, including
multiple myeloma either as a single agent or in combination with
dexamethasone, a histone deacetylase inhibitor,
anti-angiogenic/anti-VEGF or an immunomodulatory drug. Marizomib is
not approved in any country for any indications.
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,”
“plan,” “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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170724005581/en/
NovocureAshley Cordova, 212-767-7558acordova@novocure.com
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